Over-the-counter drug · ANDA
CareOne Miconazole 3 (Miconazole nitrate) NDC 41520-154
Kit · American Sales Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 41520-154-00 | 4152001540041520015400 | 1 KIT in 1 CARTON (41520-154-00) * 3 BLISTER PACK in 1 KIT / 1 SUPPOSITORY in 1 BLISTER PACK * 1 TUBE in 1 KIT / 9 g in 1 TUBEMarketed from Apr 13, 2014 |
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 3
- 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 075329
- Marketing start
- Listing expires
- Identifiers
- Product ID 41520-154_680ee6fb-3148-44b9-9ffa-a10b0fe92b85SPL ID 680ee6fb-3148-44b9-9ffa-a10b0fe92b85SPL set ID 84c43793-98e4-4e68-a3bc-3e7222135568RxCUI 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
N441520015400followed by a unit qualifier and the quantityPackage 41520-0154-00. 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 41520-154
- What is NDC 41520-154?
- 41520-154 is the product NDC for CareOne Miconazole 3 (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 3 (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 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 ANDA 075329
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.