Over-the-counter drug · ANDA
Miconazole 3 (Miconazole nitrate) NDC 51316-689
Kit · CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51316-689-00 | 5131606890051316068900 | 1 KIT in 1 CARTON (51316-689-00) * 3 BLISTER PACK in 1 KIT (0113-6650-00) / 1 SUPPOSITORY in 1 BLISTER PACK * 1 TUBE in 1 KIT (0113-8123-00) / 9 g in 1 TUBEMarketed from Apr 17, 2024 |
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 3
- Generic name (nonproprietary)
- miconazole nitrate
- Dosage form
- Kit
- Labeler
- CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNDC labeler code 51316
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075329
- Marketing start
- Listing expires
- Identifiers
- Product ID 51316-689_e55b2ee9-0e90-4788-88b1-ff25dc81b1ceSPL ID e55b2ee9-0e90-4788-88b1-ff25dc81b1ceSPL set ID 689ad530-48f9-4044-baa3-4f8b0657aeefRxCUI 992765, 992766, 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
N451316068900followed by a unit qualifier and the quantityPackage 51316-0689-00. 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 51316-689
- What is NDC 51316-689?
- 51316-689 is the product NDC for Miconazole 3 (miconazole nitrate) kit, listed with the FDA by CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Miconazole 3 (Miconazole nitrate).
- Who is the labeler?
- CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED, 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 Miconazole 3?
- 10 other product NDCs are listed under this name. See all Miconazole 3 NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Miconazole 3 products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Miconazole 3miconazole nitrate | — | Kit | Safeway | 21130-759 | 21130-0759-00 |
| miconazole 3miconazole nitrate | — | Kit | Rite Aid Corporation | 11822-0209 | 11822-0209-00 |
| miconazole 3miconazole nitrate | Miconazole nitrate 40 mg/g | CreamVaginal | Walgreen Company | 0363-2070 | 00363-2070-14 |
| Miconazole 3miconazole nitrate | — | Kit | Meijer Distribution Inc | 41250-982 | 41250-0982-00 |
| Miconazole 3miconazole nitrate | — | Kit | CVS Pharmacy | 59779-839 | 59779-0839-00 |
| Miconazole 3miconazole nitrate | — | Kit | Rite Aid Corporation | 11822-0800 | 11822-0800-00 |
| miconazole 3miconazole nitrate | — | Kit | H E B | 37808-242 | 37808-0242-00 |
| Miconazole 3miconazole nitrate | Miconazole nitrate 40 mg/g | CreamVaginal | TARGET Corporation | 11673-391 | 11673-0391-06 |
| miconazole 3miconazole nitrate | — | Kit | Kroger Company | 30142-081 | 30142-0081-00 |
| miconazole 3miconazole nitrate | — | Kit | Meijer Distribution Inc | 41250-081 | 41250-0081-00 |
Other NDCs under ANDA 075329
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.