Over-the-counter drug · NDA
Monistat 1 Combination Pack (Miconazole nitrate) NDC 63736-013
Kit · Insight Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63736-013-30 | 6373600133063736001330 | 1 KIT in 1 PACKAGE, COMBINATION (63736-013-30) * 1 SUPPOSITORY in 1 POUCH * 9 g in 1 TUBEMarketed from Jun 29, 2001 |
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)
- Monistat 1 Combination Pack
- Generic name (nonproprietary)
- miconazole nitrate
- Dosage form
- Kit
- Labeler
- Insight Pharmaceuticals LLCNDC labeler code 63736
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021308
- Marketing start
- Listing expires
- Identifiers
- Product ID 63736-013_50061b4b-e817-4ed7-8f2f-be4a17baf152SPL ID 50061b4b-e817-4ed7-8f2f-be4a17baf152SPL set ID 97ff1c90-c250-4921-81af-6a56cc9cc7d2RxCUI 992774, 992775, 992777, 992778, 998540, 998541
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
N463736001330followed by a unit qualifier and the quantityPackage 63736-0013-30. 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 63736-013
- What is NDC 63736-013?
- 63736-013 is the product NDC for Monistat 1 Combination Pack (miconazole nitrate) kit, listed with the FDA by Insight Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Monistat 1 Combination Pack (Miconazole Nitrate).
- Who is the labeler?
- Insight Pharmaceuticals LLC, NDC labeler code 63736. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Monistat 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 |
|---|---|---|---|---|
| Cvs Miconazole 1 Combination Packmiconazole nitrate | — | Kit | CVS PHARMACY, INC | 51316-093 |
| Miconazole 1 Walgreensmiconazole nitrate | — | Kit | WALGREEN COMPANY | 0363-5201 |
| Miconazole 1 Walgreensmiconazole nitrate | — | Kit | WALGREEN COMPANY | 0363-5211 |