NDC 68462-391Prescription (Rx only)FDA ANDA · ANDA209495

Esomeprazole Magnesium

Active substance: Esomeprazole Magnesium

FDA labeler: Glenmark Pharmaceuticals Inc., USA

50 formulations • 135 package configurations

All 185 registered NDCs — click to copy

In one line

Esomeprazole Magnesium (Esomeprazole Magnesium) NDC 68462-391 converts to 68462-0391-10 for billing. It is dispensed by a pharmacy and billed directly on the NDC — no HCPCS J-code is required.

FDA Approval & Market Entry Timeline

Official openFDA & DailyMed regulatory registration sequence

Listing: 68462-391 Verified

1. Initial Approval

2021

First U.S. FDA clearance for Esomeprazole Magnesium

2. FDA Application

ANDA209495

Regulatory pathway: ANDA

3. Market Entry Date

Nov 1, 2021

First commercial NDC distribution & launch date

4. Regulatory Status

Active Commercial Listing

Registration valid through Dec 31, 2026

Billing & reimbursement crosswalk

NDC • HCPCS Level II • CPT administration

Reimbursement channel

NDC direct

Oral / Topical formulation billed directly via 11-Digit NDC (No HCPCS J-Code required).

Standard pharmacy claim — no J-Code required

11-digit HIPAA NDC

68462-0391-10

Zero-padded 5-4-2 format

Standard conversion

CPT administration code

Self-Administered (Oral)

Dispensed via retail/mail pharmacy. No clinical administration procedure (CPT) required.

UB-04 revenue code

Rev 0250

0250 (General Pharmacy)

Qualifier: UN

Always verify NDC package code, billable multiplier, and invoice qualifier with specific payer guidelines before claim filing.

Every registered strength and package for Esomeprazole Magnesium, with 10-digit and 11-digit NDC formats
Formulation / role	Package NDC	Product NDC	11-digit HIPAA	Packaging detail
20 mg/1	76420-904-00	76420-904	76420-0904-00	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-904-00)
20 mg/1	76420-904-01	76420-904	76420-0904-01	100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-904-01)
20 mg/1	76420-904-12	76420-904	76420-0904-12	120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-904-12)
20 mg/1	76420-904-30	76420-904	76420-0904-30	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-904-30)
20 mg/1	76420-904-60	76420-904	76420-0904-60	60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-904-60)
20 mg/1	76420-904-90	76420-904	76420-0904-90	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-904-90)
40 mg/1	76420-905-00	76420-905	76420-0905-00	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-905-00)
40 mg/1	76420-905-01	76420-905	76420-0905-01	100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-905-01)
40 mg/1	76420-905-12	76420-905	76420-0905-12	120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-905-12)
40 mg/1	76420-905-30	76420-905	76420-0905-30	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-905-30)
40 mg/1	76420-905-60	76420-905	76420-0905-60	60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-905-60)
40 mg/1	76420-905-90	76420-905	76420-0905-90	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-905-90)
40 mg/1	82804-078-30	82804-078	82804-0078-30	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82804-078-30)
40 mg/1	82804-078-60	82804-078	82804-0078-60	60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82804-078-60)
40 mg/1	82804-078-90	82804-078	82804-0078-90	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82804-078-90)
40 mg/1	71335-2476-1	71335-2476	71335-2476-01	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2476-1)
40 mg/1	71335-2476-2	71335-2476	71335-2476-02	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2476-2)
40 mg/1	71335-2476-3	71335-2476	71335-2476-03	60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2476-3)
40 mg/1	71335-2476-4	71335-2476	71335-2476-04	10 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2476-4)
40 mg/1	71335-2476-5	71335-2476	71335-2476-05	20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2476-5)
40 mg/1	71335-2476-6	71335-2476	71335-2476-06	120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2476-6)
40 mg/1	71335-2476-7	71335-2476	71335-2476-07	180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2476-7)
375 mg/1, 20 mg/1	55111-289-60	55111-289	55111-0289-60	60 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-289-60)
20 mg/1	55910-640-01	55910-640	55910-0640-01	1 BOTTLE in 1 CARTON (55910-640-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
40 mg/1	63304-735-10	63304-735	63304-0735-10	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63304-735-10)
40 mg/1	63304-735-30	63304-735	63304-0735-30	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63304-735-30)
40 mg/1	63304-735-90	63304-735	63304-0735-90	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63304-735-90)
20 mg/1	58602-707-05	58602-707	58602-0707-05	1 BOTTLE in 1 CARTON (58602-707-05) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
20 mg/1	58602-707-61	58602-707	58602-0707-61	2 BOTTLE in 1 CARTON (58602-707-61) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
20 mg/1	58602-707-62	58602-707	58602-0707-62	3 BOTTLE in 1 CARTON (58602-707-62) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
20 mg/1	63304-734-10	63304-734	63304-0734-10	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63304-734-10)
20 mg/1	63304-734-30	63304-734	63304-0734-30	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63304-734-30)
20 mg/1	63304-734-90	63304-734	63304-0734-90	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63304-734-90)
20 mg/1	43598-509-10	43598-509	43598-0509-10	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43598-509-10)
20 mg/1	43598-509-30	43598-509	43598-0509-30	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43598-509-30)
20 mg/1	43598-509-90	43598-509	43598-0509-90	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43598-509-90)
20 mg/1	55319-051-03	55319-051	55319-0051-03	3 BOTTLE in 1 CARTON (55319-051-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
20 mg/1	55319-051-05	55319-051	55319-0051-05	1 BOTTLE in 1 CARTON (55319-051-05) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
20 mg/1	83324-200-14	83324-200	83324-0200-14	1 BOTTLE in 1 CARTON (83324-200-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
20 mg/1	83324-200-42	83324-200	83324-0200-42	3 BOTTLE in 1 CARTON (83324-200-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
20 mg/1	41520-727-01	41520-727	41520-0727-01	1 BOTTLE in 1 CARTON (41520-727-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
20 mg/1	41520-727-03	41520-727	41520-0727-03	3 BOTTLE in 1 CARTON (41520-727-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
40 mg/1	43598-510-10	43598-510	43598-0510-10	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43598-510-10)
40 mg/1	43598-510-30	43598-510	43598-0510-30	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43598-510-30)
40 mg/1	43598-510-90	43598-510	43598-0510-90	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43598-510-90)
20 mg/1	46122-821-59	46122-821	46122-0821-59	3 BOTTLE in 1 CARTON (46122-821-59) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
20 mg/1	46122-821-61	46122-821	46122-0821-61	1 BOTTLE in 1 CARTON (46122-821-61) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
20 mg/1	46122-821-62	46122-821	46122-0821-62	2 BOTTLE in 1 CARTON (46122-821-62) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
20 mg/1	68071-3419-6	68071-3419	68071-3419-06	60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-3419-6)
20 mg/1	42507-774-42	42507-774	42507-0774-42	3 BOTTLE in 1 CARTON (42507-774-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42507-774-00)
Inner component	42507-774-00	42507-774	42507-0774-00	Inner component of kit (42507-774-42)
20 mg/1	70771-1391-3	70771-1391	70771-1391-03	30 GRANULE, DELAYED RELEASE in 1 CARTON (70771-1391-3)
20 mg/1	69168-472-14	69168-472	69168-0472-14	1 BOTTLE in 1 CARTON (69168-472-14) / 14 CAPSULE in 1 BOTTLE
20 mg/1	69168-472-15	69168-472	69168-0472-15	14 CAPSULE in 1 BOTTLE (69168-472-15)
20 mg/1	69168-472-42	69168-472	69168-0472-42	3 BOTTLE in 1 CARTON (69168-472-42) / 14 CAPSULE in 1 BOTTLE
20 mg/1	69168-472-61	69168-472	69168-0472-61	1 BOTTLE in 1 CARTON (69168-472-61) / 14 CAPSULE in 1 BOTTLE
20 mg/1	69168-472-62	69168-472	69168-0472-62	3 BOTTLE in 1 CARTON (69168-472-62) / 14 CAPSULE in 1 BOTTLE
40 mg/1	70771-1392-3	70771-1392	70771-1392-03	30 GRANULE, DELAYED RELEASE in 1 CARTON (70771-1392-3)
500 mg/1, 20 mg/1	76420-889-01	76420-889	76420-0889-01	100 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-889-01)
500 mg/1, 20 mg/1	76420-889-30	76420-889	76420-0889-30	30 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-889-30)
500 mg/1, 20 mg/1	76420-889-60	76420-889	76420-0889-60	60 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-889-60)
500 mg/1, 20 mg/1	76420-889-90	76420-889	76420-0889-90	90 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-889-90)
375 mg/1, 20 mg/1	27241-202-60	27241-202	27241-0202-60	60 TABLET, DELAYED RELEASE in 1 BOTTLE (27241-202-60)
20 mg/1	50090-7990-0	50090-7990	50090-7990-00	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7990-0)
20 mg/1	50090-7990-1	50090-7990	50090-7990-01	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7990-1)
20 mg/1	50090-7990-2	50090-7990	50090-7990-02	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7990-2)
20 mg/1	68382-848-94	68382-848	68382-0848-94	30 GRANULE, DELAYED RELEASE in 1 CARTON (68382-848-94)
20 mg/1	72657-124-42	72657-124	72657-0124-42	3 BOTTLE in 1 CARTON (72657-124-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
20 mg/1	79481-0411-0	79481-0411	79481-0411-00	14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (79481-0411-0)
20 mg/1	79481-0411-1	79481-0411	79481-0411-01	3 BOTTLE in 1 CARTON (79481-0411-1) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
40 mg/1	0904-6581-68	0904-6581	00904-6581-68	60 BLISTER PACK in 1 CARTON (0904-6581-68) / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
375 mg/1, 20 mg/1	76420-890-01	76420-890	76420-0890-01	100 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-890-01)
375 mg/1, 20 mg/1	76420-890-30	76420-890	76420-0890-30	30 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-890-30)
375 mg/1, 20 mg/1	76420-890-60	76420-890	76420-0890-60	60 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-890-60)
375 mg/1, 20 mg/1	76420-890-90	76420-890	76420-0890-90	90 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-890-90)
500 mg/1, 20 mg/1	27241-203-60	27241-203	27241-0203-60	60 TABLET, DELAYED RELEASE in 1 BOTTLE (27241-203-60)
40 mg/1	50090-7991-0	50090-7991	50090-7991-00	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7991-0)
40 mg/1	50090-7991-1	50090-7991	50090-7991-01	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7991-1)
40 mg/1	50090-7991-2	50090-7991	50090-7991-02	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7991-2)
20 mg/1	67877-571-05	67877-571	67877-0571-05	500 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-571-05)
20 mg/1	67877-571-10	67877-571	67877-0571-10	1000 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-571-10)
20 mg/1	67877-571-30	67877-571	67877-0571-30	30 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-571-30)
20 mg/1	67877-571-38	67877-571	67877-0571-38	10 BLISTER PACK in 1 CARTON (67877-571-38) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK
20 mg/1	67877-571-90	67877-571	67877-0571-90	90 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-571-90)
40 mg/1	68382-849-94	68382-849	68382-0849-94	30 GRANULE, DELAYED RELEASE in 1 CARTON (68382-849-94)
20 mg/1	72657-127-42	72657-127	72657-0127-42	3 BOTTLE in 1 CARTON (72657-127-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
20 mg/1	43547-001-03	43547-001	43547-0001-03	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-001-03)
20 mg/1	43547-001-09	43547-001	43547-0001-09	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-001-09)
40 mg/1	67877-572-05	67877-572	67877-0572-05	500 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-572-05)
40 mg/1	67877-572-10	67877-572	67877-0572-10	1000 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-572-10)
40 mg/1	67877-572-30	67877-572	67877-0572-30	30 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-572-30)
40 mg/1	67877-572-38	67877-572	67877-0572-38	10 BLISTER PACK in 1 CARTON (67877-572-38) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK
40 mg/1	67877-572-90	67877-572	67877-0572-90	90 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-572-90)
375 mg/1, 20 mg/1	68788-8906-3	68788-8906	68788-8906-03	30 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8906-3)
375 mg/1, 20 mg/1	68788-8906-6	68788-8906	68788-8906-06	60 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8906-6)
40 mg/1	70518-4581-0	70518-4581	70518-4581-00	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-4581-0)
20 mg/1	71335-1170-1	71335-1170	71335-1170-01	30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1170-1)
20 mg/1	71335-1170-2	71335-1170	71335-1170-02	10 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1170-2)
20 mg/1	71335-1170-3	71335-1170	71335-1170-03	60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1170-3)
20 mg/1	71335-1170-4	71335-1170	71335-1170-04	90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1170-4)
20 mg/1	71335-1170-5	71335-1170	71335-1170-05	42 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1170-5)
20 mg/1	71335-1170-6	71335-1170	71335-1170-06	120 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1170-6)
20 mg/1	71335-1170-7	71335-1170	71335-1170-07	180 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1170-7)
20 mg/1	71335-1170-8	71335-1170	71335-1170-08	20 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1170-8)
40 mg/1	43547-002-03	43547-002	43547-0002-03	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-002-03)
40 mg/1	43547-002-09	43547-002	43547-0002-09	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-002-09)
40 mg/1	43547-002-11	43547-002	43547-0002-11	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-002-11)
20 mg/1	63868-425-14	63868-425	63868-0425-14	1 BOTTLE in 1 CARTON (63868-425-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
20 mg/1	63868-425-28	63868-425	63868-0425-28	2 BOTTLE in 1 CARTON (63868-425-28) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
20 mg/1	63868-425-42	63868-425	63868-0425-42	3 BOTTLE in 1 CARTON (63868-425-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
40 mg/1	72789-391-90	72789-391	72789-0391-90	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72789-391-90)
40 mg/1	82009-034-10	82009-034	82009-0034-10	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82009-034-10)
40 mg/1	82009-034-90	82009-034	82009-0034-90	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82009-034-90)
20 mg/1	68071-3735-3	68071-3735	68071-3735-03	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-3735-3)
20 mg/1	68071-3735-6	68071-3735	68071-3735-06	60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-3735-6)
20 mg/1	80425-0419-1	80425-0419	80425-0419-01	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0419-1)
20 mg/1	80425-0419-2	80425-0419	80425-0419-02	60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0419-2)
20 mg/1	80425-0419-3	80425-0419	80425-0419-03	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0419-3)
20 mg/1	82009-033-10	82009-033	82009-0033-10	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82009-033-10)
20 mg/1	72288-898-01	72288-898	72288-0898-01	1 BOTTLE in 1 CARTON (72288-898-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
20 mg/1	72288-898-03	72288-898	72288-0898-03	3 BOTTLE in 1 CARTON (72288-898-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
20 mg/1	80425-0420-1	80425-0420	80425-0420-01	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0420-1)
20 mg/1	80425-0420-2	80425-0420	80425-0420-02	60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0420-2)
20 mg/1	80425-0420-3	80425-0420	80425-0420-03	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0420-3)
20 mg/1	69618-073-42	69618-073	69618-0073-42	3 BOTTLE in 1 CARTON (69618-073-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
20 mg/1	71335-2505-1	71335-2505	71335-2505-01	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2505-1)
20 mg/1	71335-2505-2	71335-2505	71335-2505-02	10 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2505-2)
20 mg/1	71335-2505-3	71335-2505	71335-2505-03	60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2505-3)
20 mg/1	71335-2505-4	71335-2505	71335-2505-04	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2505-4)
20 mg/1	71335-2505-5	71335-2505	71335-2505-05	42 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2505-5)
20 mg/1	71335-2505-6	71335-2505	71335-2505-06	120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2505-6)
20 mg/1	71335-2505-7	71335-2505	71335-2505-07	180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2505-7)
20 mg/1	71335-2505-8	71335-2505	71335-2505-08	20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2505-8)
20 mg/1	42507-898-42	42507-898	42507-0898-42	3 BOTTLE in 1 CARTON (42507-898-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42507-898-00)
Inner component	42507-898-00	42507-898	42507-0898-00	Inner component of kit (42507-898-42)

Taken from the manufacturer's FDA Structured Product Labeling submission. This is the label as filed, not a summary.

3 Label Sections

INDICATIONS AND USAGE

Uses treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

DOSAGE AND ADMINISTRATION

Directions adults 18 years of age and older this product is to be used once a day (every 24 hours), every day for 14 days may take 1 to 4 days for full effect 14-Day Course of Treatment • swallow 1 tablet with a glass of water before eating in the morning • take every day for 14 days • do not take more than 1 tablet a day • swallow whole. Do not crush or chew capsules. • do not use for more than 14 days unless directed by your doctor Repeated 14-Day Courses (if needed) • you may repeat a 14-day course every 4 months • do not take for more than 14 days or more often than every 4 months unless directed by a doctor children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition .

WARNINGS AND PRECAUTIONS

Warnings Allergy alert : Do not use if you are allergic to esomeprazole. Esomeprazole may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If an allergic reaction occurs, stop use and seek medical help right away.

Pharmacologic class

Cytochrome P450 2C19 Inhibitors

Every other National Drug Code registered in the same established class.

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Cytochrome P450 2C19 Inhibitors