Over-the-counter drug · NDA
Miconazole 1 Walgreens (Miconazole nitrate) NDC 0363-5211
Kit · WALGREEN COMPANY
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-5211-01 | 0036352110100363521101 | 1 KIT in 1 PACKAGE, COMBINATION (0363-5211-01) * 1 SUPPOSITORY in 1 POUCH (0363-5212-01) * 9 g in 1 TUBE (0363-5213-01)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 Walgreens
- Generic name (nonproprietary)
- miconazole nitrate
- Dosage form
- Kit
- Labeler
- WALGREEN COMPANYNDC labeler code 0363
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021308
- Marketing start
- Listing expires
- Identifiers
- Product ID 0363-5211_e2284e64-e6c7-4492-b399-b3aba97eafcaSPL ID e2284e64-e6c7-4492-b399-b3aba97eafcaSPL set ID 9679f4a5-c27b-46ea-9983-c2a111d3d2c3RxCUI 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
N400363521101followed by a unit qualifier and the quantityPackage 00363-5211-01. 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.
About NDC 0363-5211
- What is NDC 0363-5211?
- 0363-5211 is the product NDC for Miconazole 1 Walgreens (miconazole nitrate) kit, listed with the FDA by WALGREEN COMPANY. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Miconazole 1 Walgreens (Miconazole Nitrate).
- Who is the labeler?
- WALGREEN COMPANY, NDC labeler code 0363. 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 1 Walgreens?
- 1 other product NDC are listed under this name. See all Miconazole 1 Walgreens NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Miconazole 1 Walgreens products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Miconazole 1 Walgreensmiconazole nitrate | — | Kit | WALGREEN COMPANY | 0363-5201 | 00363-5201-01 |
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 |
| Monistat 1 Combination Packmiconazole nitrate | — | Kit | Insight Pharmaceuticals LLC | 63736-013 |