Over-the-counter drug · ANDA
Rugby Miconazole 3 (miconazole nitrate) NDC 0536-1425
Kit · Rugby Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0536-1425-41 | 00536142541 | 1 KIT in 1 CARTON (0536-1425-41) * 1 APPLICATOR in 1 POUCH (0113-7198-00) / 5 g in 1 APPLICATOR * 1 TUBE in 1 CARTON (0113-8123-00) / 9 g in 1 TUBEMarketed from Apr 23, 2024 |
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)
- Rugby Miconazole 3
- Generic name (nonproprietary)
- miconazole nitrate
- Dosage form
- Kit
- Labeler
- Rugby Laboratories
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076357
- Marketing start
- Marketing end
- Identifiers
- Product ID 0536-1425_1ce3070d-0513-43e8-99f9-c582bb707f51SPL ID 1ce3070d-0513-43e8-99f9-c582bb707f51SPL set ID 2d7035fa-9695-4d66-89f5-bd26420450efRxCUI 992816, 998540, 998544
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
N400536142541followed by a unit qualifier and the quantityPackage 00536-1425-41. 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.
Other NDCs under ANDA 076357
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| foster and thrive miconazole 3miconazole nitrate | — | Kit | Strategic Sourcing Services LLC | 70677-1223 |
| Up and Up Miconazole 3miconazole nitrate | — | Kit | Target Corporation | 11673-982 |
| Miconazole 3miconazole nitrate | — | Kit | Meijer Distribution Inc | 41250-982 |
| Leader Miconazole 3miconazole nitrate | — | Kit | Cardinal Health 110, LLC. dba Leader | 70000-0669 |
| Miconazole 3miconazole nitrate | — | Kit | Rite Aid Corporation | 11822-0800 |
| Miconazole 3miconazole nitrate | — | Kit | CVS Pharmacy | 59779-839 |