Over-the-counter drug · NDA
Monistat 7 with Reusable Applicator NDC 63736-025
miconazole nitrate · Miconazole nitrate 20 mg/g · Cream · Vaginal · Insight Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63736-025-15 | 63736002515 | 1 TUBE, WITH APPLICATOR in 1 CARTON (63736-025-15) / 45 g in 1 TUBE, WITH APPLICATORMarketed from Apr 26, 1993 |
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)
- Monistat 7 with Reusable ApplicatorSuffix: with Reusable Applicator
- Generic name (nonproprietary)
- miconazole nitrate
- Active ingredients
- Miconazole nitrate — 20 mg/g
- Dosage form
- Cream
- Route
- Vaginal
- Labeler
- Insight Pharmaceuticals LLC
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 017450
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)
- Identifiers
- Product ID 63736-025_3db33d36-edb7-4a2f-aef6-93f10581452aSPL ID 3db33d36-edb7-4a2f-aef6-93f10581452aSPL set ID 2aad40f2-4eea-441d-8b34-5613f1955405RxCUI 998540, 998541UNII 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
N463736002515followed by a unit qualifier and the quantityPackage 63736-0025-15. 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 NDA 017450
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 |
|---|---|---|---|---|
| Monistat 7 7-Day Disposable Applicatorsmiconazole nitrate | Miconazole nitrate 20 mg/g | CreamVaginal | Insight Pharmaceuticals LLC | 63736-026 |
| Monistat 7 Combination Pack 7-Day Pre-Filled Applicatorsmiconazole nitrate | — | Kit | Insight Pharmaceuticals LLC | 63736-023 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.