Miconazole Nitrate
- Product NDC
- 51672-2070
- 11-digit product format
- 516722070
- Labeler code
- 51672
- Product ID
- 51672-2070_38e566b7-9252-2731-e063-6294a90ad263
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Miconazole Nitrate
- Dosage form
- CREAM
- Route
- VAGINAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA076773
- Marketing category
- ANDA
- Marketing start
- 2005-03-02
- Substance
- MICONAZOLE NITRATE
- Active strength
- 40 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 Nitrate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MICONAZOLE NITRATE | 40 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | VW4H1CYW1K |
| Rxcui | 998544 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51672-2070-9 | Miconazole Nitrate | 25 g in 1 TUBE, WITH APPLICATOR | CREAM | 25 | | 5 |
| 51672-2070-9 | Miconazole Nitrate | 1 in 1 CARTON | CREAM | 1 | | 5 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Miconazole Nitrate | ACTIVE INGREDIENT | VW4H1CYW1K | MICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] | 1 | |
| Miconazole | ACTIVE MOIETY | 7NNO0D7S5M | MICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] | 1 | |
| cetyl alcohol | INACTIVE INGREDIENT | 936JST6JCN | MICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] | 1 | |
| isopropyl myristate | INACTIVE INGREDIENT | 0RE8K4LNJS | MICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] | 1 | |
| polysorbate 60 | INACTIVE INGREDIENT | CAL22UVI4M | MICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] | 1 | |
| polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | MICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] | 1 | |
| potassium hydroxide | INACTIVE INGREDIENT | WZH3C48M4T | MICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] | 1 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | MICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] | 1 | |
| sorbitan monostearate | INACTIVE INGREDIENT | NVZ4I0H58X | MICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] | 1 | |
| stearyl alcohol | INACTIVE INGREDIENT | 2KR89I4H1Y | MICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | MICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51672-2070 | MICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240524_eaca3e39-6ea0-4d7e-803c-db22024ad9f9.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 |
|---|
| 51672-2070-9 | 51672207009 | 1 TUBE, WITH APPLICATOR in 1 CARTON (51672-2070-9) / 25 g in 1 TUBE, WITH APPLICATOR | 2005-03-02 | 0000-00-00 | No | No | Current |