NDC 12578-488OTC monographFDA BULK INGREDIENT

Generic formulation

Active substance: Miconazole Nitrate

50 formulations • 59 package configurations

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Generic formulation (Miconazole Nitrate) NDC 12578-488 converts to 12578-0488-90 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: 12578-488

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

12578-0488-90

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 Generic formulation, with 10-digit and 11-digit NDC formats
Formulation / role	Package NDC	Product NDC	11-digit HIPAA	Packaging detail
3 g/150g	59779-097-53	59779-097	59779-0097-53	150 g in 1 CAN (59779-097-53)
2.6 g/130g	56104-121-01	56104-121	56104-0121-01	130 g in 1 CANISTER (56104-121-01)
1.42 g/71g	56104-253-01	56104-253	56104-0253-01	71 g in 1 BOTTLE, PLASTIC (56104-253-01)
20 mg/g	56104-500-00	56104-500	56104-0500-00	71 g in 1 BOTTLE, PLASTIC (56104-500-00)
20 mg/g	56104-903-01	56104-903	56104-0903-01	150 g in 1 CAN (56104-903-01)
20 mg/g	56104-907-01	56104-907	56104-0907-01	130 g in 1 CAN (56104-907-01)
2.6 g/130g	69256-039-46	69256-039	69256-0039-46	130 g in 1 CAN (69256-039-46)
2 g/100g	84558-025-01	84558-025	84558-0025-01	100 g in 1 BOTTLE (84558-025-01)
1.3 g/130g	69256-038-46	69256-038	69256-0038-46	130 g in 1 PACKAGE (69256-038-46)
2 g/100g	77338-041-25	77338-041	77338-0041-25	113 g in 1 TUBE (77338-041-25)
2 g/100g	71399-0071-1	71399-0071	71399-0071-01	1 TUBE in 1 BOX (71399-0071-1) / 14.2 g in 1 TUBE
2 g/100g	71399-0071-3	71399-0071	71399-0071-03	1 TUBE in 1 BOX (71399-0071-3) / 28.4 g in 1 TUBE
2 g/100g	71399-0071-4	71399-0071	71399-0071-04	1 TUBE in 1 BOX (71399-0071-4) / 42.5 g in 1 TUBE
2 g/100g	69771-041-25	69771-041	69771-0041-25	113 g in 1 TUBE (69771-041-25)
20 mg/mL	50268-503-29	50268-503	50268-0503-29	29.57 mL in 1 BOTTLE (50268-503-29)
2 g/100g	69771-165-03	69771-165	69771-0165-03	85 g in 1 BOTTLE, PLASTIC (69771-165-03)
2.6 g/130g	21130-212-00	21130-212	21130-0212-00	130 g in 1 CAN (21130-212-00)
20 mg/g	50090-4356-0	50090-4356	50090-4356-00	1 TUBE, WITH APPLICATOR in 1 CARTON (50090-4356-0) / 45 g in 1 TUBE, WITH APPLICATOR
20 mg/g	69571-016-01	69571-016	69571-0016-01	28.4 g in 1 TUBE (69571-016-01)
2 g/100g	69571-017-01	69571-017	69571-0017-01	113.4 g in 1 TUBE (69571-017-01)
200 mg/1	0472-1738-03	0472-1738	00472-1738-03	3 SUPPOSITORY in 1 CARTON (0472-1738-03)
3 g/150g	68016-516-00	68016-516	68016-0516-00	150 g in 1 CAN (68016-516-00)
2 g/100g	0536-1375-75	0536-1375	00536-1375-75	1 TUBE in 1 BOX (0536-1375-75) / 28.3 g in 1 TUBE
2 g/100g	68788-8845-3	68788-8845	68788-8845-03	1 TUBE in 1 BOX (68788-8845-3) / 30 g in 1 TUBE
2.6 g/130g	0363-7418-00	0363-7418	00363-7418-00	130 g in 1 CANISTER (0363-7418-00)
20 mg/g	51672-2001-1	51672-2001	51672-2001-01	1 TUBE in 1 CARTON (51672-2001-1) / 15 g in 1 TUBE
20 mg/g	51672-2001-2	51672-2001	51672-2001-02	1 TUBE in 1 CARTON (51672-2001-2) / 30 g in 1 TUBE
2.6 g/130g	63868-180-46	63868-180	63868-0180-46	130 g in 1 CAN (63868-180-46)
20 mg/g	50090-7364-0	50090-7364	50090-7364-00	1 TUBE in 1 CARTON (50090-7364-0) / 30 g in 1 TUBE
20 mg/g	51672-2035-6	51672-2035	51672-2035-06	1 TUBE, WITH APPLICATOR in 1 CARTON (51672-2035-6) / 45 g in 1 TUBE, WITH APPLICATOR
20 mg/g	51672-2035-7	51672-2035	51672-2035-07	1 TUBE, WITH APPLICATOR in 1 CARTON (51672-2035-7) / 45 g in 1 TUBE, WITH APPLICATOR
20 mg/g	83324-233-46	83324-233	83324-0233-46	130 g in 1 CAN (83324-233-46)
1.42 g/71g	69842-490-25	69842-490	69842-0490-25	71 g in 1 BOTTLE, PLASTIC (69842-490-25)
40 mg/g	51672-2070-9	51672-2070	51672-2070-09	1 TUBE, WITH APPLICATOR in 1 CARTON (51672-2070-9) / 25 g in 1 TUBE, WITH APPLICATOR
1.3 g/130g	69842-502-46	69842-502	69842-0502-46	130 g in 1 PACKAGE (69842-502-46)
2 g/100g	10135-720-85	10135-720	10135-0720-85	85 g in 1 BOTTLE (10135-720-85)
1.42 g/71g	36800-385-25	36800-385	36800-0385-25	71 g in 1 BOTTLE, PLASTIC (36800-385-25)
2.6 g/130g	69842-511-46	69842-511	69842-0511-46	130 g in 1 CAN (69842-511-46)
2.6 g/130g	36800-384-46	36800-384	36800-0384-46	130 g in 1 CAN (36800-384-46)
1.42 g/71g	72446-007-71	72446-007	72446-0007-71	71 g in 1 BOTTLE, PLASTIC (72446-007-71)
20 mg/g	72446-014-01	72446-014	72446-0014-01	71 g in 1 BOTTLE, PLASTIC (72446-014-01)
Outer kit carton	0713-0593-77	0713-0593	00713-0593-77	1 KIT in 1 CARTON (0713-0593-77) * 9 SUPPOSITORY in 1 BLISTER PACK * 9 g in 1 TUBE
20 mg/g	84387-003-01	84387-003	84387-0003-01	28.4 g in 1 TUBE (84387-003-01)
2 g/100g	68788-8895-3	68788-8895	68788-8895-03	1 TUBE in 1 BOX (68788-8895-3) / 28.3 g in 1 TUBE
2 g/100g	69396-014-04	69396-014	69396-0014-04	118.3 g in 1 TUBE (69396-014-04)
2 g/100g	69396-014-05	69396-014	69396-0014-05	15 g in 1 TUBE (69396-014-05)
2 g/100g	69396-014-20	69396-014	69396-0014-20	1 TUBE in 1 BOX (69396-014-20) / 30 g in 1 TUBE
2 g/100g	69396-014-33	69396-014	69396-0014-33	3 TUBE in 1 BOX (69396-014-33) / 30 g in 1 TUBE
2 g/100g	69396-014-44	69396-014	69396-0014-44	4 TUBE in 1 BOX (69396-014-44) / 30 g in 1 TUBE
2 g/100g	69396-014-66	69396-014	69396-0014-66	6 TUBE in 1 BOX (69396-014-66) / 30 g in 1 TUBE
20 mg/g	53943-976-01	53943-976	53943-0976-01	71 g in 1 BOTTLE, PLASTIC (53943-976-01)
3 g/150g	0363-4208-53	0363-4208	00363-4208-53	150 g in 1 CAN (0363-4208-53)
2 g/100g	42291-938-85	42291-938	42291-0938-85	85 g in 1 BOTTLE (42291-938-85)
20 mg/g	79481-0621-1	79481-0621	79481-0621-01	71 g in 1 BOTTLE, PLASTIC (79481-0621-1)
2.6 g/130g	41520-565-46	41520-565	41520-0565-46	130 g in 1 CAN (41520-565-46)
2 g/100g	68071-3429-3	68071-3429	68071-3429-03	1 TUBE in 1 BOX (68071-3429-3) / 30 g in 1 TUBE
20 mg/g	51824-078-01	51824-078	51824-0078-01	28 g in 1 TUBE (51824-078-01)
1.3 g/130g	41520-566-46	41520-566	41520-0566-46	130 g in 1 CAN (41520-566-46)
20 mg/g	49348-689-72	49348-689	49348-0689-72	1 TUBE in 1 CARTON (49348-689-72) / 30 g in 1 TUBE

Taken from the manufacturer's FDA Structured Product Labeling submission. This is the label as filed, not a summary. Initial U.S. approval: 2023.

Highlights

These highlights do not include all the information needed to use Generic formulation safely and effectively. The full sections follow.

Indications and usage: AREXVY is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in: • Individuals 60 years of age and older. • Individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV. Limitations of Use: AREXVY is not for use in pregnant individuals.
Dosage and administration: For intramuscular use only. • After reconstitution, a single dose of AREXVY is either 0.5 mL (vial and vial presentation) or approximately 0.5 mL (vial and prefilled syringe presentation). • Supplied as two presentations: (1) Vial of Lyophilized Antigen Component reconstituted with accompanying Adjuvant Suspension Component vial; (2) Vial of Lyophilized Antigen Component reconstituted with accompanying prefilled syringe of Adjuvant Suspension Component.
Dosage forms and strengths: For injectable suspension: Single dose after reconstitution is 0.5 mL (vial/vial) or approximately 0.5 mL (vial/prefilled syringe).
Contraindications: History of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine.
Warnings and precautions: • Guillain-Barré Syndrome: Postmarketing observational study suggests an increased risk of Guillain-Barré syndrome during the 42 days following vaccination. • Allergic Reactions: Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions. • Syncope: Syncope (fainting) may occur; procedures should be in place to avoid injury from falling. • Altered Immunocompetence: Immunocompromised persons may have a diminished immune response.
Adverse reactions: • Most commonly reported adverse reactions (≥10%) in adults ≥60 years: injection site pain (60.9%), fatigue (33.6%), myalgia (28.9%), headache (27.2%), and arthralgia (18.1%). • In adults 50–59 years: injection site pain (75.8%), fatigue (39.8%), myalgia (35.6%), headache (31.7%), arthralgia (23.4%), erythema (13.2%), and swelling (10.4%). • In adults 18–49 years: injection site pain (76.0%), myalgia (59.9%), fatigue (59.6%), headache (43.6%), and arthralgia (28.3%).

13 Label Sections

INDICATIONS AND USAGE

AREXVY is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in: • Individuals 60 years of age and older. • Individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV. Limitations of Use: AREXVY is not for use in pregnant individuals [see Use in Specific Populations (8.1)].

DOSAGE AND ADMINISTRATION

2.1 Dose and Schedule After reconstitution, a single dose of AREXVY is either 0.5 mL (vial and vial presentation) or approximately 0.5 mL (vial and prefilled syringe presentation). 2.2 Preparation & Reconstitution Instructions AREXVY is supplied in two presentations that must be combined prior to administration: • Vial and Vial Presentation: Reconstitute the Lyophilized Antigen Component (sterile white powder) with the accompanying Adjuvant Suspension Component (opalescent, colorless to pale brownish liquid). Use only the supplied Adjuvant Suspension Component for reconstitution. Withdraw entire contents of adjuvant vial and slowly transfer into antigen powder vial. Gently swirl until completely dissolved. • Vial and Prefilled Syringe Presentation: Reconstitute the Lyophilized Antigen Component vial with the accompanying prefilled syringe of Adjuvant Suspension Component. Slowly transfer entire contents into antigen vial and gently swirl until powder dissolves. 2.3 Administration For intramuscular (IM) injection only, preferably in the deltoid region. After reconstitution, administer AREXVY immediately or store protected from light in the refrigerator between 2°C and 8°C (36°F to 46°F) or at room temperature [up to 25°C (77°F)] and use within 4 hours. Discard reconstituted vaccine if not used within 4 hours.

DOSAGE FORMS AND STRENGTHS

For injectable suspension. • For the vial and vial presentation, a single dose after reconstitution is 0.5 mL. • For the vial and prefilled syringe presentation, a single dose after reconstitution is approximately 0.5 mL.

CONTRAINDICATIONS

Do not administer AREXVY to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of AREXVY [see Description (11)].

WARNINGS AND PRECAUTIONS

5.1 Guillain-Barré Syndrome The results of a postmarketing observational study suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination with AREXVY [see Adverse Reactions (6.2)]. 5.2 Preventing and Managing Allergic Reactions Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of AREXVY. 5.3 Syncope Syncope (fainting) may occur in association with administration of injectable vaccines, including AREXVY. Procedures should be in place to avoid injury from fainting. 5.4 Altered Immunocompetence Immunocompromised persons, including those receiving immunosuppressive therapy, may have a diminished immune response to AREXVY.

ADVERSE REACTIONS

6.1 Clinical Trials Experience The safety of AREXVY was evaluated in over 17,879 vaccine recipients in multi-center clinical trials (Study 1: NCT04886596 in 24,966 participants). Most Commonly Reported Solicited Adverse Reactions: • Adults ≥60 years: Injection site pain (60.9%), Fatigue (33.6%), Myalgia (28.9%), Headache (27.2%), Arthralgia (18.1%), Erythema (7.5%), Swelling (5.5%), Fever (2.0%). • Adults 50–59 years: Injection site pain (75.8%), Fatigue (39.8%), Myalgia (35.6%), Headache (31.7%), Arthralgia (23.4%), Erythema (13.2%), Swelling (10.4%). • Adults 18–49 years: Injection site pain (76.0%), Myalgia (59.9%), Fatigue (59.6%), Headache (43.6%), Arthralgia (28.3%). 6.2 Postmarketing Experience Postmarketing surveillance identified cases of Guillain-Barré syndrome and acute hypersensitivity reactions following administration.

DRUG INTERACTIONS & CONCOMITANT ADMINISTRATION

USE IN SPECIFIC POPULATIONS

DESCRIPTION

CLINICAL PHARMACOLOGY

CLINICAL STUDIES

HOW SUPPLIED / STORAGE AND HANDLING

AREXVY is supplied as: • Outer Carton Kit (58160-848-11): 1 vial of Lyophilized Antigen Component (58160-723-03) and 1 vial of Adjuvant Suspension Component (58160-744-03). • Outer Carton Kit (58160-894-15): 1 vial of Lyophilized Antigen Component (58160-719-03) and 1 prefilled syringe of Adjuvant Suspension Component (58160-749-07). • Outer Carton Kit (58160-882-12): 1 vial of Lyophilized Antigen Component (58160-719-03) and 1 prefilled syringe of Adjuvant Suspension Component (58160-749-07). Storage before Reconstitution: Store in refrigerator between 2°C and 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze. Discard if frozen. Storage after Reconstitution: Use immediately or store in refrigerator at 2°C to 8°C or room temperature up to 25°C (77°F) for up to 4 hours.

PATIENT COUNSELING INFORMATION

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Highlights

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