Miconazole Nitrate
- Product NDC
- 50090-4356
- 11-digit product format
- 500904356
- Labeler code
- 50090
- Product ID
- 50090-4356_e0ebd43f-a346-46cc-be47-7f4de5dff3e9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Miconazole Nitrate
- Dosage form
- CREAM
- Route
- VAGINAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA074444
- Marketing category
- ANDA
- Marketing start
- 1997-01-13
- Substance
- MICONAZOLE NITRATE
- Active strength
- 20 mg/g
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Miconazole Nitrate
- Listing expiration
- 2027-12-31
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 |
|---|
| 50090-4356-0 | Miconazole Nitrate | 45 g in 1 TUBE, WITH APPLICATOR | CREAM | 45 | | 9 |
| 50090-4356-0 | Miconazole Nitrate | 1 in 1 CARTON | CREAM | 1 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-4356 | MICONAZOLE NITRATE CREAM [A-S MEDICATION SOLUTIONS] | 7 | Current NDC, Legacy NDC, 2 package rows | 20231216_a32fc37b-bcad-4f56-8dc6-cf36a6716196.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 |
|---|
| 50090-4356-0 | 50090435600 | 1 TUBE, WITH APPLICATOR in 1 CARTON (50090-4356-0) / 45 g in 1 TUBE, WITH APPLICATOR | 2019-06-14 | 0000-00-00 | No | No | Current |