Over-the-counter drug · NDA
Cvs Miconazole 1 Combination Pack (Miconazole nitrate) NDC 51316-093
Kit · CVS PHARMACY, INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51316-093-01 | 5131600930151316009301 | 1 KIT in 1 PACKAGE, COMBINATION (51316-093-01) * 1 SUPPOSITORY in 1 POUCH (51316-094-01) * 9 g in 1 TUBE (51316-095-01)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)
- Cvs Miconazole 1 Combination Pack
- Generic name (nonproprietary)
- miconazole nitrate
- Dosage form
- Kit
- Labeler
- CVS PHARMACY, INCNDC labeler code 51316
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021308
- Marketing start
- Listing expires
- Identifiers
- Product ID 51316-093_0a2c3afd-9556-4ab3-87bd-1720ffa32af5SPL ID 0a2c3afd-9556-4ab3-87bd-1720ffa32af5SPL set ID db40f672-62b4-4844-a2d3-7e8617c40ec9RxCUI 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
N451316009301followed by a unit qualifier and the quantityPackage 51316-0093-01. 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 .
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.
About NDC 51316-093
- What is NDC 51316-093?
- 51316-093 is the product NDC for Cvs Miconazole 1 Combination Pack kit, listed with the FDA by CVS PHARMACY, INC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cvs Miconazole 1 Combination Pack (Miconazole Nitrate).
- Who is the labeler?
- CVS PHARMACY, INC, NDC labeler code 51316. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cvs Miconazole 1 Combination Pack?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under NDA 021308
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Miconazole 1 Walgreensmiconazole nitrate | — | Kit | WALGREEN COMPANY | 0363-5201 |
| Miconazole 1 Walgreensmiconazole nitrate | — | Kit | WALGREEN COMPANY | 0363-5211 |
| Monistat 1 Combination Packmiconazole nitrate | — | Kit | Insight Pharmaceuticals LLC | 63736-013 |