Over-the-counter drug · ANDA
careone miconazole 1 (Miconazole nitrate) NDC 41520-616
Kit · American Sales Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 41520-616-00 | 4152006160041520061600 | 1 KIT in 1 CARTON (41520-616-00) * 1 SUPPOSITORY in 1 POUCH * 9 g in 1 TUBEMarketed from Jan 15, 2020 |
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)
- careone miconazole 1
- Generic name (nonproprietary)
- miconazole nitrate
- Dosage form
- Kit
- Labeler
- American Sales CompanyNDC labeler code 41520
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079114
- Marketing start
- Listing expires
- Identifiers
- Product ID 41520-616_23802cdc-7a89-4009-af85-8ad1f1a3046dSPL ID 23802cdc-7a89-4009-af85-8ad1f1a3046dSPL set ID f51af8e2-fb06-4842-8021-b7efd515022eRxCUI 992774, 992775, 998483, 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
N441520061600followed by a unit qualifier and the quantityPackage 41520-0616-00. 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 41520-616
- What is NDC 41520-616?
- 41520-616 is the product NDC for careone miconazole 1 (miconazole nitrate) kit, listed with the FDA by American Sales Company. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- careone miconazole 1 (Miconazole nitrate).
- Who is the labeler?
- American Sales Company, NDC labeler code 41520. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for careone miconazole 1?
- 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 ANDA 079114
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.