Over-the-counter drug · ANDA
Leader Miconazole 3 (miconazole nitrate) NDC 70000-0669
Kit · Cardinal Health 110, LLC. dba Leader
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70000-0669-1 | 70000066901 | 1 KIT in 1 CARTON (70000-0669-1) * 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 Jun 27, 2024 |
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)
- Leader Miconazole 3
- Generic name (nonproprietary)
- miconazole nitrate
- Dosage form
- Kit
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076357
- Marketing start
- Listing expires
- Identifiers
- Product ID 70000-0669_1c6314df-4429-4d58-bdc2-12830d55f036SPL ID 1c6314df-4429-4d58-bdc2-12830d55f036SPL set ID 7f6df893-f404-4b2d-ab2b-696c8a2d36faRxCUI 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
N470000066901followed by a unit qualifier and the quantityPackage 70000-0669-01. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
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 |
| Rugby Miconazole 3miconazole nitrate | — | Kit | Rugby Laboratories | 0536-1425 |
| Up and Up Miconazole 3miconazole nitrate | — | Kit | Target Corporation | 11673-982 |
| Miconazole 3miconazole nitrate | — | Kit | Meijer Distribution Inc | 41250-982 |
| Miconazole 3miconazole nitrate | — | Kit | Rite Aid Corporation | 11822-0800 |
| Miconazole 3miconazole nitrate | — | Kit | CVS Pharmacy | 59779-839 |