Over-the-counter drug · ANDA
Vagistat 3 (Miconazole nitrate) NDC 11509-0081
Kit · Combe Incorporated
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11509-0081-1 | 1150900810111509008101 | 1 KIT in 1 CARTON (11509-0081-1) * 3 BLISTER PACK in 1 KIT / 1 SUPPOSITORY in 1 BLISTER PACK * 1 TUBE in 1 KIT / 9 g in 1 TUBEMarketed from Mar 27, 2018 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Vagistat 3
- Generic name (nonproprietary)
- miconazole nitrate
- Dosage form
- Kit
- Labeler
- Combe IncorporatedNDC labeler code 11509
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075329
- Marketing start
- Listing expires
- Identifiers
- Product ID 11509-0081_9181ac4a-a921-4c23-a199-eb62910b33f5SPL ID 9181ac4a-a921-4c23-a199-eb62910b33f5SPL set ID e15a28cd-9e64-4e9e-8df9-829d84f1816cRxCUI 992765, 992766, 992791, 992792, 998540, 1359442
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
N411509008101followed by a unit qualifier and the quantityPackage 11509-0081-01. 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 11509-0081
- What is NDC 11509-0081?
- 11509-0081 is the product NDC for Vagistat 3 (miconazole nitrate) kit, listed with the FDA by Combe Incorporated. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Vagistat 3 (Miconazole nitrate).
- Who is the labeler?
- Combe Incorporated, NDC labeler code 11509. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Vagistat 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.