Miconazole 1 Combination Pack NDC 51316-005

NDC codes

FDA NDC Directory

Product NDC (as listed)51316-005Labeler and product segments. Claims need a package NDC.

Product NDC at billing width51316-0005Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
51316-005-01	51316000501	1 KIT in 1 PACKAGE, COMBINATION (51316-005-01) * 9 g in 1 TUBE (51316-091-01) * 1 SUPPOSITORY in 1 POUCH (51316-090-01)Marketed from Jan 30, 2022

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Miconazole 1 Combination Pack
Generic name (nonproprietary): miconazole nitrate
Dosage form: Kit
Labeler: CVS PHARMACY, INC
Product type: Over-the-counter drug
Marketing category: NDA — New Drug ApplicationApplication NDA 020670
Marketing start: Jan 30, 2022
Listing expires: Dec 31, 2027
Identifiers: Product ID 51316-005_ceb2e359-e195-4a2c-82ea-9dd13cebcbebSPL ID ceb2e359-e195-4a2c-82ea-9dd13cebcbebSPL set ID 4cbf37d1-023d-496f-84c8-a1b2a83a10efRxCUI 992774, 992775, 998540

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N451316000501 followed by a unit qualifier and the quantity

Package 51316-0005-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jan 29, 2026.

Indications (excerpt from the label)

Uses treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 020670

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 020670
Product	Strength	Form · route	Labeler	Product NDC
Monistat 3miconazole nitrate	—	Kit	Insight Pharmaceuticals LLC	63736-017
Monistat 3 Combination Pack 3 Ovule Insertsmiconazole nitrate	—	Kit	Insight Pharmaceuticals LLC	63736-019
Miconazole 3 Walgreen Companymiconazole nitrate	—	KitVaginal	WALGREEN COMPANY	0363-5203

Miconazole 1 Combination Pack (miconazole nitrate) NDC 51316-005