NDC 49483-003OTC monographFDA OTC MONOGRAPH NOT FINAL · part334

Stimulant laxative

Active substance: Bisacodyl

FDA labeler: TIME CAP LABORATORIES, INC.

47 formulations • 106 package configurations

All 153 registered NDCs — click to copy

In one line

Stimulant laxative (Bisacodyl) NDC 49483-003 converts to 49483-0003-00 for billing. It is dispensed by a pharmacy and billed directly on the NDC — no HCPCS J-code is required.

openFDA Live Registry SyncHIPAA 5-4-2 StandardCMS Level II Crosswalk

Listing: 49483-003

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

49483-0003-00

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

Every registered strength and package for STIMULANT LAXATIVE, with 10-digit and 11-digit NDC formats
Formulation / role	Package NDC	Product NDC	11-digit HIPAA	Packaging detail
8.6 mg/1, 50 mg/1	70000-0526-1	70000-0526	70000-0526-01	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70000-0526-1)
8.6 mg/1, 50 mg/1	70000-0526-2	70000-0526	70000-0526-02	200 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70000-0526-2)
15 mg/1	63941-980-24	63941-980	63941-0980-24	2 POUCH in 1 CARTON (63941-980-24) / 12 TABLET, CHEWABLE in 1 POUCH
5 mg/1	49483-003-00	49483-003	49483-0003-00	100000 TABLET, DELAYED RELEASE in 1 CARTON (49483-003-00)
5 mg/1	49483-003-01	49483-003	49483-0003-01	100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (49483-003-01)
5 mg/1	49483-003-10	49483-003	49483-0003-10	1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (49483-003-10)
5 mg/1	49483-003-52	49483-003	49483-0003-52	25 TABLET, DELAYED RELEASE in 1 BLISTER PACK (49483-003-52)
5 mg/1	57896-441-01	57896-441	57896-0441-01	100 TABLET in 1 BOTTLE (57896-441-01)
5 mg/1	57896-441-10	57896-441	57896-0441-10	1000 TABLET in 1 BOTTLE (57896-441-10)
5 mg/1	57896-441-20	57896-441	57896-0441-20	200 TABLET in 1 BOTTLE (57896-441-20)
5 mg/1	57896-441-25	57896-441	57896-0441-25	1 BLISTER PACK in 1 CARTON (57896-441-25) / 25 TABLET in 1 BLISTER PACK
5 mg/1	57896-441-26	57896-441	57896-0441-26	25 TABLET in 1 BOTTLE (57896-441-26)
50 mg/1, 8.6 mg/1	63868-875-01	63868-875	63868-0875-01	100 TABLET in 1 BOTTLE, PLASTIC (63868-875-01)
5 mg/1	63868-908-25	63868-908	63868-0908-25	1 BLISTER PACK in 1 CARTON (63868-908-25) / 25 TABLET, COATED in 1 BLISTER PACK
15 mg/1	49035-349-24	49035-349	49035-0349-24	2 POUCH in 1 CARTON (49035-349-24) / 12 TABLET, CHEWABLE in 1 POUCH
8.6 mg/1, 50 mg/1	11673-209-01	11673-209	11673-0209-01	100 TABLET in 1 BOTTLE (11673-209-01)
25 mg/1	0067-8142-01	0067-8142	00067-8142-01	2 BLISTER PACK in 1 CARTON (0067-8142-01) / 12 PILL in 1 BLISTER PACK
25 mg/1	0067-8142-02	0067-8142	00067-8142-02	4 BLISTER PACK in 1 CARTON (0067-8142-02) / 12 PILL in 1 BLISTER PACK
15 mg/1	55910-365-12	55910-365	55910-0365-12	1 POUCH in 1 CARTON (55910-365-12) / 12 TABLET, CHEWABLE in 1 POUCH
5 mg/1	68163-116-25	68163-116	68163-0116-25	1 BLISTER PACK in 1 CARTON (68163-116-25) / 25 TABLET, COATED in 1 BLISTER PACK
15 mg/1	83455-300-24	83455-300	83455-0300-24	24 TABLET, CHEWABLE in 1 CARTON (83455-300-24)
8.6 mg/1, 50 mg/1	71335-2693-1	71335-2693	71335-2693-01	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2693-1)
8.6 mg/1, 50 mg/1	71335-2693-2	71335-2693	71335-2693-02	120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2693-2)
8.6 mg/1, 50 mg/1	71335-2693-3	71335-2693	71335-2693-03	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2693-3)
8.6 mg/1, 50 mg/1	71335-2693-4	71335-2693	71335-2693-04	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2693-4)
8.6 mg/1, 50 mg/1	71335-2693-5	71335-2693	71335-2693-05	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2693-5)
8.6 mg/1, 50 mg/1	71335-2693-6	71335-2693	71335-2693-06	28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2693-6)
8.6 mg/1, 50 mg/1	71335-2693-7	71335-2693	71335-2693-07	56 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2693-7)
8.6 mg/1, 50 mg/1	71335-2693-8	71335-2693	71335-2693-08	14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2693-8)
8.6 mg/1, 50 mg/1	71335-2693-9	71335-2693	71335-2693-09	20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2693-9)
5 mg/1	41415-116-25	41415-116	41415-0116-25	1 BLISTER PACK in 1 CARTON (41415-116-25) / 25 TABLET, COATED in 1 BLISTER PACK
15 mg/1	51316-734-01	51316-734	51316-0734-01	2 BLISTER PACK in 1 CARTON (51316-734-01) / 15 TABLET, SUGAR COATED in 1 BLISTER PACK
15 mg/1	0067-8140-01	0067-8140	00067-8140-01	1 PACKAGE in 1 BOX (0067-8140-01) / 12 TABLET, CHEWABLE in 1 PACKAGE
15 mg/1	0067-8140-02	0067-8140	00067-8140-02	2 PACKAGE in 1 BOX (0067-8140-02) / 12 TABLET, CHEWABLE in 1 PACKAGE
15 mg/1	0067-8140-03	0067-8140	00067-8140-03	4 PACKAGE in 1 BOX (0067-8140-03) / 12 TABLET, CHEWABLE in 1 PACKAGE
50 mg/1, 8.6 mg/1	69842-881-10	69842-881	69842-0881-10	1 BOTTLE, PLASTIC in 1 BOX (69842-881-10) / 100 TABLET in 1 BOTTLE, PLASTIC
50 mg/1, 8.6 mg/1	69842-881-40	69842-881	69842-0881-40	400 TABLET in 1 BOTTLE, PLASTIC (69842-881-40)
50 mg/1, 8.6 mg/1	21130-829-20	21130-829	21130-0829-20	200 TABLET in 1 BOTTLE, PLASTIC (21130-829-20)
50 mg/1, 8.6 mg/1	69842-887-10	69842-887	69842-0887-10	1 BOTTLE, PLASTIC in 1 BOX (69842-887-10) / 100 TABLET in 1 BOTTLE, PLASTIC
50 mg/1, 8.6 mg/1	69842-887-25	69842-887	69842-0887-25	250 TABLET in 1 BOTTLE, PLASTIC (69842-887-25)
50 mg/1, 8.6 mg/1	69842-887-40	69842-887	69842-0887-40	400 TABLET in 1 BOTTLE, PLASTIC (69842-887-40)
8.6 mg/1, 50 mg/1	41226-209-06	41226-209	41226-0209-06	60 TABLET, COATED in 1 BOTTLE (41226-209-06)
50 mg/1, 8.6 mg/1	72476-855-10	72476-855	72476-0855-10	1 BOTTLE, PLASTIC in 1 BOX (72476-855-10) / 100 TABLET in 1 BOTTLE, PLASTIC
5 mg/1	71335-1531-0	71335-1531	71335-1531-00	25 TABLET in 1 BOTTLE (71335-1531-0)
5 mg/1	71335-1531-1	71335-1531	71335-1531-01	30 TABLET in 1 BOTTLE (71335-1531-1)
5 mg/1	71335-1531-2	71335-1531	71335-1531-02	2 TABLET in 1 BOTTLE (71335-1531-2)
5 mg/1	71335-1531-3	71335-1531	71335-1531-03	3 TABLET in 1 BOTTLE (71335-1531-3)
5 mg/1	71335-1531-4	71335-1531	71335-1531-04	4 TABLET in 1 BOTTLE (71335-1531-4)
5 mg/1	71335-1531-5	71335-1531	71335-1531-05	10 TABLET in 1 BOTTLE (71335-1531-5)
5 mg/1	71335-1531-6	71335-1531	71335-1531-06	90 TABLET in 1 BOTTLE (71335-1531-6)
5 mg/1	71335-1531-7	71335-1531	71335-1531-07	8 TABLET in 1 BOTTLE (71335-1531-7)
5 mg/1	71335-1531-8	71335-1531	71335-1531-08	100 TABLET in 1 BOTTLE (71335-1531-8)
5 mg/1	71335-1531-9	71335-1531	71335-1531-09	20 TABLET in 1 BOTTLE (71335-1531-9)
50 mg/1, 8.6 mg/1	72476-878-10	72476-878	72476-0878-10	1 BOTTLE, PLASTIC in 1 BOX (72476-878-10) / 100 TABLET in 1 BOTTLE, PLASTIC
50 mg/1, 8.6 mg/1	21130-878-20	21130-878	21130-0878-20	200 TABLET in 1 BOTTLE, PLASTIC (21130-878-20)
5 mg/1	42507-167-10	42507-167	42507-0167-10	1 BLISTER PACK in 1 CARTON (42507-167-10) / 10 TABLET in 1 BLISTER PACK
5 mg/1	42507-167-52	42507-167	42507-0167-52	1 BLISTER PACK in 1 CARTON (42507-167-52) / 25 TABLET in 1 BLISTER PACK
5 mg/1	69452-541-83	69452-541	69452-0541-83	300 TABLET, DELAYED RELEASE in 1 BOTTLE (69452-541-83)
50 mg/1, 8.6 mg/1	41163-829-10	41163-829	41163-0829-10	100 TABLET in 1 BOTTLE, PLASTIC (41163-829-10)
8.6 mg/1, 50 mg/1	79481-0304-1	79481-0304	79481-0304-01	100 TABLET, FILM COATED in 1 BOTTLE (79481-0304-1)
15 mg/1	36800-994-01	36800-994	36800-0994-01	2 POUCH in 1 CARTON (36800-994-01) / 12 TABLET, CHEWABLE in 1 POUCH
50 mg/1, 8.6 mg/1	51316-318-06	51316-318	51316-0318-06	1 BOTTLE in 1 CARTON (51316-318-06) / 60 CAPSULE, LIQUID FILLED in 1 BOTTLE
5 mg/1	51316-327-03	51316-327	51316-0327-03	1 BLISTER PACK in 1 CARTON (51316-327-03) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK
5 mg/1	51316-327-15	51316-327	51316-0327-15	2 BLISTER PACK in 1 CARTON (51316-327-15) / 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK
5 mg/1	51316-327-33	51316-327	51316-0327-33	7 BLISTER PACK in 1 CARTON (51316-327-33) / 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK
5 mg/1	51316-327-56	51316-327	51316-0327-56	1 BLISTER PACK in 1 CARTON (51316-327-56) / 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK
8.6 mg/1, 50 mg/1	17856-1248-1	17856-1248	17856-1248-01	100 POUCH in 1 BOX, UNIT-DOSE (17856-1248-1) / 1 TABLET, FILM COATED in 1 POUCH
50 mg/1, 8.6 mg/1	53943-154-01	53943-154	53943-0154-01	1 BOTTLE in 1 CARTON (53943-154-01) / 100 TABLET in 1 BOTTLE
8.6 mg/1, 50 mg/1	68788-7674-1	68788-7674	68788-7674-01	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-7674-1)
8.6 mg/1, 50 mg/1	68788-7674-6	68788-7674	68788-7674-06	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-7674-6)
15 mg/1	0067-8141-01	0067-8141	00067-8141-01	1 BLISTER PACK in 1 CARTON (0067-8141-01) / 8 TABLET in 1 BLISTER PACK
15 mg/1	0067-8141-02	0067-8141	00067-8141-02	2 BLISTER PACK in 1 CARTON (0067-8141-02) / 15 TABLET in 1 BLISTER PACK
5 mg/1	41167-0200-1	41167-0200	41167-0200-01	1 BLISTER PACK in 1 CARTON (41167-0200-1) / 10 TABLET, COATED in 1 BLISTER PACK
5 mg/1	41167-0200-2	41167-0200	41167-0200-02	1 BLISTER PACK in 1 CARTON (41167-0200-2) / 25 TABLET, COATED in 1 BLISTER PACK
5 mg/1	41167-0200-3	41167-0200	41167-0200-03	2 BLISTER PACK in 1 CARTON (41167-0200-3) / 25 TABLET, COATED in 1 BLISTER PACK
5 mg/1	41167-0200-4	41167-0200	41167-0200-04	4 BLISTER PACK in 1 CARTON (41167-0200-4) / 25 TABLET, COATED in 1 BLISTER PACK
5 mg/1	41167-0200-5	41167-0200	41167-0200-05	1 BLISTER PACK in 1 CARTON (41167-0200-5) / 8 TABLET, COATED in 1 BLISTER PACK
5 mg/1	41167-0200-6	41167-0200	41167-0200-06	8 BLISTER PACK in 1 CARTON (41167-0200-6) / 25 TABLET, COATED in 1 BLISTER PACK
5 mg/1	41167-0200-8	41167-0200	41167-0200-08	3 BLISTER PACK in 1 CARTON (41167-0200-8) / 10 TABLET, COATED in 1 BLISTER PACK
5 mg/1	66424-002-01	66424-002	66424-0002-01	100 TABLET in 1 BOTTLE (66424-002-01)
5 mg/1	41167-0290-5	41167-0290	41167-0290-05	1 BLISTER PACK in 1 CARTON (41167-0290-5) / 25 TABLET, COATED in 1 BLISTER PACK
5 mg/1	85766-148-00	85766-148	85766-0148-00	1000 TABLET in 1 BOTTLE (85766-148-00)
5 mg/1	85766-148-01	85766-148	85766-0148-01	100 TABLET in 1 BOTTLE (85766-148-01)
5 mg/1	85766-148-02	85766-148	85766-0148-02	200 TABLET in 1 BOTTLE (85766-148-02)
5 mg/1	85766-148-25	85766-148	85766-0148-25	1 BLISTER PACK in 1 CARTON (85766-148-25) / 25 TABLET in 1 BLISTER PACK
5 mg/1	85766-148-26	85766-148	85766-0148-26	25 TABLET in 1 BOTTLE (85766-148-26)
5 mg/1	71610-453-02	71610-453	71610-0453-02	2 TABLET in 1 BOTTLE (71610-453-02)
5 mg/1	71610-453-04	71610-453	71610-0453-04	4 TABLET in 1 BOTTLE (71610-453-04)
5 mg/1	71610-453-20	71610-453	71610-0453-20	20 TABLET in 1 BOTTLE (71610-453-20)
5 mg/1	41167-0400-1	41167-0400	41167-0400-01	1 BLISTER PACK in 1 CARTON (41167-0400-1) / 10 TABLET, COATED in 1 BLISTER PACK
5 mg/1	41167-0400-2	41167-0400	41167-0400-02	1 BLISTER PACK in 1 CARTON (41167-0400-2) / 25 TABLET, COATED in 1 BLISTER PACK
5 mg/1	41167-0400-3	41167-0400	41167-0400-03	2 BLISTER PACK in 1 CARTON (41167-0400-3) / 25 TABLET, COATED in 1 BLISTER PACK
5 mg/1	41167-0400-4	41167-0400	41167-0400-04	4 BLISTER PACK in 1 CARTON (41167-0400-4) / 25 TABLET, COATED in 1 BLISTER PACK
5 mg/1	41167-0400-5	41167-0400	41167-0400-05	1 BLISTER PACK in 1 CARTON (41167-0400-5) / 8 TABLET, COATED in 1 BLISTER PACK
5 mg/1	41167-0400-6	41167-0400	41167-0400-06	8 BLISTER PACK in 1 CARTON (41167-0400-6) / 25 TABLET, COATED in 1 BLISTER PACK
5 mg/1	41167-0400-8	41167-0400	41167-0400-08	3 BLISTER PACK in 1 CARTON (41167-0400-8) / 10 TABLET, COATED in 1 BLISTER PACK
5 mg/1	41167-0400-9	41167-0400	41167-0400-09	1 BLISTER PACK in 1 CARTON (41167-0400-9) / 6 TABLET, COATED in 1 BLISTER PACK
50 mg/1, 8.6 mg/1	59726-855-10	59726-855	59726-0855-10	100 TABLET in 1 BOTTLE, PLASTIC (59726-855-10)
50 mg/1, 8.6 mg/1	59726-855-40	59726-855	59726-0855-40	400 TABLET in 1 BOTTLE, PLASTIC (59726-855-40)
8.6 mg/1, 50 mg/1	0536-1248-01	0536-1248	00536-1248-01	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0536-1248-01)
8.6 mg/1, 50 mg/1	0536-1248-10	0536-1248	00536-1248-10	1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0536-1248-10)
50 mg/1, 8.6 mg/1	59726-878-10	59726-878	59726-0878-10	100 TABLET in 1 BOTTLE, PLASTIC (59726-878-10)
50 mg/1, 8.6 mg/1	59726-878-40	59726-878	59726-0878-40	400 TABLET in 1 BOTTLE, PLASTIC (59726-878-40)
50 mg/1, 8.6 mg/1	37808-549-29	37808-549	37808-0549-29	240 TABLET in 1 BOTTLE (37808-549-29)
50 mg/1, 8.6 mg/1	36800-084-01	36800-084	36800-0084-01	1 BOTTLE, PLASTIC in 1 BOX (36800-084-01) / 100 TABLET in 1 BOTTLE, PLASTIC
8.6 mg/1, 50 mg/1	50804-304-10	50804-304	50804-0304-10	100 TABLET, FILM COATED in 1 BOTTLE (50804-304-10)

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 for relief of occasional constipation and irregularity this product generally produces bowel movement in 6 to 12 hours

DOSAGE AND ADMINISTRATION

Directions take with a glass of water do not take more than directed adults and children 12 years and older: take 1 to 3 tablets in a single daily dose children 12 and under: ask a doctor

WARNINGS AND PRECAUTIONS

Warnings Do not use if you cannot swallow without chewing Ask a doctor before use if you have • stomach pain, nausea, vomiting • noticed a sudden change in bowel habits that lasts more than 2 weeks When using this product • do not chew or crush tablet(s) • do not use within 1 hour after taking an antacid or milk • it may cause stomach discomfort, faintness and cramps Stop use and ask a doctor if • you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition. • you need to use a laxative for more than 1 week If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Pharmacologic class

Increased Large Intestinal Motility

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

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Prescribing information

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Increased Large Intestinal Motility