Over-the-counter drug · ANDA
MICONAZOLE 3 COMBINATION PACK (miconazole nitrate) kit (Miconazole nitrate) NDC 0713-0593
Kit · Cosette Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0713-0593-77 | 0071305937700713059377 | 1 KIT in 1 CARTON (0713-0593-77) * 9 SUPPOSITORY in 1 BLISTER PACK * 9 g in 1 TUBEMarketed from Jan 3, 2025 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 COMBINATION PACK (miconazole nitrate) kit
- Generic name (nonproprietary)
- miconazole nitrate
- Dosage form
- Kit
- Labeler
- Cosette Pharmaceuticals, Inc.NDC labeler code 0713
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074926
- Marketing start
- Listing expires
- Identifiers
- Product ID 0713-0593_2b1109b2-d1c4-6d16-e063-6394a90a5df5SPL ID 2b1109b2-d1c4-6d16-e063-6394a90a5df5SPL set ID eed88487-a7ba-4853-8519-13f92ed5539fRxCUI 992765, 992766, 998483, 998540UPC 0307130593779
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
N400713059377followed by a unit qualifier and the quantityPackage 00713-0593-77. 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 0713-0593
- What is NDC 0713-0593?
- 0713-0593 is the product NDC for MICONAZOLE 3 COMBINATION PACK (miconazole nitrate) kit kit, listed with the FDA by Cosette Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- MICONAZOLE 3 COMBINATION PACK (miconazole nitrate) kit (Miconazole nitrate).
- Who is the labeler?
- Cosette Pharmaceuticals, Inc., NDC labeler code 0713. 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 COMBINATION PACK (miconazole nitrate) kit?
- 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 ANDA 074926
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 3 Combination Packmiconazole nitrate | — | Kit | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 49035-345 |
| Miconazole 3 Combination Packmiconazole nitrate | — | Kit | CVS Pharmacy | 59779-773 |
| Miconazole 3 Combination Packmiconazole nitrate | — | Kit | Chain Drug Consortium, LLC | 68016-731 |