Miconazole 7
- Product NDC
- 68071-3544
- 11-digit product format
- 680713544
- Labeler code
- 68071
- Product ID
- 68071-3544_2d3fbb35-987f-7d36-e063-6394a90a1acd
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Miconazole Nitrate
- Dosage form
- CREAM
- Route
- VAGINAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA074164
- Marketing category
- ANDA
- Marketing start
- 2021-03-15
- Substance
- MICONAZOLE NITRATE
- Active strength
- 20 mg/g
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Miconazole 7
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MICONAZOLE NITRATE | 20 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | VW4H1CYW1K |
| Rxcui | 998540 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3544-7 | Miconazole 7 | 1 in 1 CARTON | CREAM | 1 | | 2 |
| 68071-3544-7 | Miconazole 7 | 45 g in 1 TUBE, WITH APPLICATOR | CREAM | 45 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3544 | MICONAZOLE 7 (MICONAZOLE NITRATE) CREAM [NUCARE PHARMACEUTICALS,INC.] | 2 | Current NDC, 2 package rows | 20250205_0c055a0d-1031-e7d5-e063-6294a90a17e2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3544-7 | 68071354407 | 1 TUBE, WITH APPLICATOR in 1 CARTON (68071-3544-7) / 45 g in 1 TUBE, WITH APPLICATOR | 2023-12-08 | No | No | Current |