Over-the-counter drug · ANDA
Miconazole 7 (miconazole nitrate) NDC 70000-0009
Miconazole nitrate 20 mg/g · Cream · Vaginal · Cardinal Health (Leader) 70000
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70000-0009-1 | 70000000901 | 1 TUBE, WITH APPLICATOR in 1 CARTON (70000-0009-1) / 45 g in 1 TUBE, WITH APPLICATORMarketed from Jul 1, 2019 |
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)
- Miconazole 7
- Generic name (nonproprietary)
- miconazole nitrate
- Active ingredients
- Miconazole nitrate — 20 mg/g
- Dosage form
- Cream
- Route
- Vaginal
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074164
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)
- Identifiers
- Product ID 70000-0009_3e750b76-007d-470a-8c7d-5c5f4f6cbbc9SPL ID 3e750b76-007d-470a-8c7d-5c5f4f6cbbc9SPL set ID 5081411c-02d0-4f7d-8496-d6adccbe00aeRxCUI 998540UNII VW4H1CYW1K
- Pharmacologic class
- Azole Antifungal
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
N470000000901followed by a unit qualifier and the quantityPackage 70000-0009-01. 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.
Other NDCs under ANDA 074164
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 |
|---|---|---|---|---|
| Miconazole 7miconazole nitrate | Miconazole nitrate 20 mg/g | CreamVaginal | QUALITY CHOICE (Chain Drug Marketing Association) | 63868-198 |
| Miconazole 7miconazole nitrate | Miconazole nitrate 20 mg/g | CreamVaginal | Walgreens | 0363-0730 |
| Miconazole 7miconazole nitrate | Miconazole nitrate 20 mg/g | CreamVaginal | Preferred Pharmaceuticals Inc. | 68788-8661 |
| Miconazole 7miconazole nitrate | Miconazole nitrate 20 mg/g | CreamVaginal | Major Pharmaceuticals | 0904-7734 |
| Miconazole 7miconazole nitrate | Miconazole nitrate 20 mg/g | CreamVaginal | H2-Pharma, LLC | 61269-730 |
| Miconazole 7miconazole nitrate | Miconazole nitrate 20 mg/g | CreamVaginal | H2-Pharma, LLC | 61269-730 |
| Miconazole 7miconazole nitrate | Miconazole nitrate 100 mg/g | CreamVaginal | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 49035-347 |
| Miconazole 7miconazole nitrate | Miconazole nitrate 20 mg/g | CreamVaginal | NuCare Pharmaceuticals,Inc. | 68071-3544 |
| Miconazole 7miconazole nitrate | Miconazole nitrate 20 mg/g | CreamVaginal | Family Dollar (FAMILY WELLNESS) | 55319-573 |
| Miconazole 7miconazole nitrate | Miconazole nitrate 20 mg/g | CreamVaginal | QUALITY CHOICE (Chain Drug Marketing Association) | 83324-160 |
| Miconazole 7miconazole nitrate | Miconazole nitrate 20 mg/g | CreamVaginal | P & L Development, LLC | 59726-988 |
| Miconazole 7miconazole nitrate | Miconazole nitrate 20 mg/g | CreamVaginal | Preferred Pharmaceuticals Inc. | 68788-7917 |