Over-the-counter drug · ANDA
Good Sense Miconazole 3 (Miconazole nitrate) NDC 0113-0081
Kit · L. Perrigo Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0113-0081-00 | 0011300810000113008100 | 1 KIT in 1 CARTON (0113-0081-00) * 1 BLISTER PACK in 1 KIT / 3 SUPPOSITORY in 1 BLISTER PACK * 1 TUBE in 1 KIT / 9 g in 1 TUBEMarketed from Apr 2, 2007 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Good Sense Miconazole 3
- Generic name (nonproprietary)
- miconazole nitrate
- Dosage form
- Kit
- Labeler
- L. Perrigo CompanyNDC labeler code 0113
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075329
- Marketing start
- Listing expires
- Identifiers
- Product ID 0113-0081_791ad24a-cafd-46c8-87d7-9ad3351452eeSPL ID 791ad24a-cafd-46c8-87d7-9ad3351452eeSPL set ID 9aeac709-001b-4617-8046-186264847ec8RxCUI 992765, 992766, 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
N400113008100followed by a unit qualifier and the quantityPackage 00113-0081-00. 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 0113-0081
- What is NDC 0113-0081?
- 0113-0081 is the product NDC for Good Sense Miconazole 3 (miconazole nitrate) kit, listed with the FDA by L. Perrigo Company. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Good Sense Miconazole 3 (Miconazole nitrate).
- Who is the labeler?
- L. Perrigo Company, NDC labeler code 0113. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Good Sense Miconazole 3?
- 1 other product NDC are listed under this name. See all Good Sense Miconazole 3 NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Good Sense Miconazole 3 products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Good Sense Miconazole 3miconazole nitrate | Miconazole nitrate 40 mg/g | CreamVaginal | L. Perrigo Company | 0113-7110 | 00113-7110-14 |
Other NDCs under ANDA 075329
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.