Over-the-counter drug · NDA
Miconazole 1 Walgreens (miconazole nitrate) NDC 0363-5201
Kit · WALGREEN COMPANY
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-5201-01 | 00363520101 | 1 KIT in 1 PACKAGE, COMBINATION (0363-5201-01) * 1 SUPPOSITORY in 1 POUCH (0363-5204-01) * 9 g in 1 TUBE (0363-5205-01)Marketed from Nov 30, 2021 |
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 1 WalgreensSuffix: Walgreens
- Generic name (nonproprietary)
- miconazole nitrate
- Dosage form
- Kit
- Labeler
- WALGREEN COMPANY
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021308
- Marketing start
- Listing expires
- Identifiers
- Product ID 0363-5201_2a57ccf7-f616-40e9-a19d-2a0c547c1084SPL ID 2a57ccf7-f616-40e9-a19d-2a0c547c1084SPL set ID 1fe7b02a-f60b-4572-b4e8-35bda290b176RxCUI 992774, 992775, 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
N400363520101followed by a unit qualifier and the quantityPackage 00363-5201-01. 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 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 |
| Monistat 1 Combination Packmiconazole nitrate | — | Kit | Insight Pharmaceuticals LLC | 63736-013 |
| Miconazole 1 Walgreensmiconazole nitrate | — | Kit | WALGREEN COMPANY | 0363-5211 |