Over-the-counter drug · NDA
Monistat 3 (Miconazole nitrate) NDC 63736-017
Kit · Insight Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63736-017-03 | 6373600170363736001703 | 1 KIT in 1 PACKAGE, COMBINATION (63736-017-03) * 3 SUPPOSITORY in 1 BLISTER PACK * 9 g in 1 TUBEMarketed from Apr 16, 1996 |
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 3
- 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 020670
- Marketing start
- Listing expires
- Identifiers
- Product ID 63736-017_5c3d76c4-7f00-29fe-e063-6294a90a1167SPL ID 5c3d76c4-7f00-29fe-e063-6294a90a1167
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
N463736001703followed by a unit qualifier and the quantityPackage 63736-0017-03. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 63736-017
- What is NDC 63736-017?
- 63736-017 is the product NDC for Monistat 3 (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 3 (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 3?
- 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 020670
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 Combination Packmiconazole nitrate | — | Kit | CVS PHARMACY, INC | 51316-005 |
| Miconazole 3 Walgreen Companymiconazole nitrate | — | KitVaginal | WALGREEN COMPANY | 0363-5203 |
| Monistat 3 Combination Pack 3 Ovule Insertsmiconazole nitrate | — | Kit | Insight Pharmaceuticals LLC | 63736-019 |