Over-the-counter drug · ANDA
Equaline Miconazole 3 (Miconazole nitrate) NDC 41163-081
Kit · United Natural Foods, Inc. dba UNFI
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 41163-081-00 | 4116300810041163008100 | 1 KIT in 1 CARTON (41163-081-00) * 3 BLISTER PACK in 1 KIT / 1 SUPPOSITORY in 1 BLISTER PACK * 1 TUBE in 1 KIT / 9 g in 1 TUBEMarketed from Jan 16, 2012 |
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)
- Equaline Miconazole 3
- Generic name (nonproprietary)
- miconazole nitrate
- Dosage form
- Kit
- Labeler
- United Natural Foods, Inc. dba UNFINDC labeler code 41163
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075329
- Marketing start
- Listing expires
- Identifiers
- Product ID 41163-081_a5e83e40-c878-42a4-9a8b-44a89500b25aSPL ID a5e83e40-c878-42a4-9a8b-44a89500b25aSPL set ID 89328324-72d9-4b3d-bec7-cc2e4e62f034RxCUI 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
N441163008100followed by a unit qualifier and the quantityPackage 41163-0081-00. 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 41163-081
- What is NDC 41163-081?
- 41163-081 is the product NDC for Equaline Miconazole 3 (miconazole nitrate) kit, listed with the FDA by United Natural Foods, Inc. dba UNFI. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Equaline Miconazole 3 (Miconazole nitrate).
- Who is the labeler?
- United Natural Foods, Inc. dba UNFI, NDC labeler code 41163. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Equaline 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.