Over-the-counter drug · ANDA
topcare miconazole 3 combination pack (Miconazole nitrate) NDC 36800-081
Kit · Topco Associates LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36800-081-00 | 3680000810036800008100 | 1 KIT in 1 CARTON (36800-081-00) * 3 BLISTER PACK in 1 KIT / 1 SUPPOSITORY in 1 BLISTER PACK * 1 TUBE in 1 KIT / 9 g in 1 TUBEMarketed from May 10, 2000 |
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)
- topcare miconazole 3 combination packSuffix: combination pack
- Generic name (nonproprietary)
- miconazole nitrate
- Dosage form
- Kit
- Labeler
- Topco Associates LLCNDC labeler code 36800
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075329
- Marketing start
- Listing expires
- Identifiers
- Product ID 36800-081_28b14543-3ba9-4c9c-a9bd-a94d1ca3bc90SPL ID 28b14543-3ba9-4c9c-a9bd-a94d1ca3bc90SPL set ID 0af4c06a-aa79-48ab-9857-e0f56317d8f3RxCUI 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
N436800008100followed by a unit qualifier and the quantityPackage 36800-0081-00. 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 36800-081
- What is NDC 36800-081?
- 36800-081 is the product NDC for topcare miconazole 3 combination pack kit, listed with the FDA by Topco Associates LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- topcare miconazole 3 combination pack (Miconazole nitrate).
- Who is the labeler?
- Topco Associates LLC, NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for topcare miconazole 3 combination pack?
- 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.