Miconazole 7
- Product NDC
- 68788-7917
- 11-digit product format
- 687887917
- Labeler code
- 68788
- Product ID
- 68788-7917_06d213df-c3b7-4683-b23b-e7be0c506bf0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Miconazole Nitrate
- Dosage form
- CREAM
- Route
- VAGINAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA074164
- Marketing category
- ANDA
- Marketing start
- 2021-05-27
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-7917-4 | Miconazole 7 | 45 g in 1 TUBE, WITH APPLICATOR | CREAM | 45 | | 5 |
| 68788-7917-4 | Miconazole 7 | 1 in 1 CARTON | CREAM | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-7917 | MICONAZOLE 7 (MICONAZOLE NITRATE) CREAM [PREFERRED PHARMACEUTICALS INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240719_99c66cbd-7063-4b4c-b827-4f2fcb6ed67f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68788-7917-4 | 68788791704 | 1 TUBE, WITH APPLICATOR in 1 CARTON (68788-7917-4) / 45 g in 1 TUBE, WITH APPLICATOR | 2021-05-27 | 0000-00-00 | No | No | Current |