Over-the-counter drug · NDA
Miconazole 3 Walgreen Company (miconazole nitrate) NDC 0363-5203
Kit · Vaginal · WALGREEN COMPANY
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-5203-01 | 00363520301 | 1 KIT in 1 PACKAGE, COMBINATION (0363-5203-01) * 1 APPLICATOR in 1 PACKAGE / 1 SUPPOSITORY in 1 APPLICATOR * 9 g in 1 TUBEMarketed from Apr 18, 2016 |
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 Walgreen CompanySuffix: Walgreen Company
- Generic name (nonproprietary)
- miconazole nitrate
- Dosage form
- Kit
- Route
- Vaginal
- Labeler
- WALGREEN COMPANY
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020670
- Marketing start
- Listing expires
- Identifiers
- Product ID 0363-5203_ebf44c6d-f4bb-48b9-9171-e69fc64e321aSPL ID ebf44c6d-f4bb-48b9-9171-e69fc64e321aSPL set ID 32b373be-9c8e-49b0-a796-8d87f6a20cefRxCUI 992765, 992766, 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
N400363520301followed by a unit qualifier and the quantityPackage 00363-5203-01. 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 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 |
|---|---|---|---|---|
| Monistat 3miconazole nitrate | — | Kit | Insight Pharmaceuticals LLC | 63736-017 |
| Monistat 3 Combination Pack 3 Ovule Insertsmiconazole nitrate | — | Kit | Insight Pharmaceuticals LLC | 63736-019 |
| Miconazole 1 Combination Packmiconazole nitrate | — | Kit | CVS PHARMACY, INC | 51316-005 |