Over-the-counter drug · ANDA
topcare miconazole 1 (miconazole nitrate) NDC 36800-199
Kit · Topco Associates LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36800-199-00 | 36800019900 | 1 KIT in 1 CARTON (36800-199-00) * 1 SUPPOSITORY in 1 POUCH * 9 g in 1 TUBEMarketed from Jun 17, 2010 |
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)
- topcare miconazole 1
- Generic name (nonproprietary)
- miconazole nitrate
- Dosage form
- Kit
- Labeler
- Topco Associates LLC
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079114
- Marketing start
- Listing expires
- Identifiers
- Product ID 36800-199_6dced9d2-bf58-46d6-b7fa-00bb97ee90d4SPL ID 6dced9d2-bf58-46d6-b7fa-00bb97ee90d4SPL set ID 8138de63-c7e9-4b2c-a0e2-c62292a0b320RxCUI 992774, 992775, 998483, 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
N436800019900followed by a unit qualifier and the quantityPackage 36800-0199-00. 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.
Other NDCs under ANDA 079114
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 |
|---|---|---|---|---|
| Foster And Thrive Miconazole 1miconazole nitrate | — | Kit | Strategic Sourcing Services LLC | 70677-1294 |
| miconazole 1 yeast infection reliefmiconazole nitrate | — | Kit | CVS Pharmacy | 59779-199 |
| careone miconazole 1miconazole nitrate | — | Kit | American Sales Company | 41520-616 |
| miconazole 1miconazole nitrate | — | Kit | Meijer Distribution Inc | 41250-199 |
| miconazole 1miconazole nitrate | — | Kit | Kroger Company | 30142-199 |
| Signature Care Miconazole 1miconazole nitrate | — | Kit | Safeway | 21130-040 |
| Basic Care Miconazolemiconazole nitrate | — | Kit | Amazon.com Services LLC | 72288-199 |
| equate miconazole 1miconazole nitrate | — | Kit | Wal-Mart Stores Inc | 49035-199 |
| Good Neighbor Pharmacy Miconazole 1miconazole nitrate | — | Kit | Amerisource Bergen | 46122-577 |
| up and up miconazolemiconazole nitrate | — | Kit | Target Corporation | 11673-199 |
| Miconazole 1miconazole nitrate | — | Kit | Safeway | 21130-929 |
| miconazole 1miconazole nitrate | — | Kit | H E B | 37808-199 |
| exchange select miconazole 1miconazole nitrate | — | Kit | Army & Air Force Exchange Service | 55301-211 |