Ketoconazole
- Product NDC
- 51672-1298
- 11-digit product format
- 516721298
- Labeler code
- 51672
- Product ID
- 51672-1298_395c0795-2343-b8c0-e063-6294a90a5505
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketoconazole
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA075638
- Marketing category
- ANDA
- Marketing start
- 2002-12-18
- Substance
- KETOCONAZOLE
- Active strength
- 20 mg/g
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ketoconazole
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| KETOCONAZOLE | 20 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R9400W927I |
| Rxcui | 203088 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Ketoconazole | ACTIVE INGREDIENT | R9400W927I | KETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP] | 1 | |
| Ketoconazole | ACTIVE INGREDIENT | R9400W927I | KETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] | 1 | |
| Ketoconazole | ACTIVE INGREDIENT | R9400W927I | KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.] | 1 | |
| Ketoconazole | ACTIVE MOIETY | R9400W927I | KETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP] | 1 | |
| Ketoconazole | ACTIVE MOIETY | R9400W927I | KETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] | 1 | |
| Ketoconazole | ACTIVE MOIETY | R9400W927I | KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.] | 1 | |
| butylated hydroxyanisole | INACTIVE INGREDIENT | REK4960K2U | KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.] | 1 | |
| Butylated Hydroxyanisole | INACTIVE INGREDIENT | REK4960K2U | KETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP] | 1 | |
| butylated hydroxyanisole | INACTIVE INGREDIENT | REK4960K2U | KETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] | 1 | |
| cetyl alcohol | INACTIVE INGREDIENT | 936JST6JCN | KETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP] | 1 | |
| cetyl alcohol | INACTIVE INGREDIENT | 936JST6JCN | KETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] | 1 | |
| cetyl alcohol | INACTIVE INGREDIENT | 936JST6JCN | KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.] | 1 | |
| isopropyl myristate | INACTIVE INGREDIENT | 0RE8K4LNJS | KETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP] | 1 | |
| isopropyl myristate | INACTIVE INGREDIENT | 0RE8K4LNJS | KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.] | 1 | |
| isopropyl myristate | INACTIVE INGREDIENT | 0RE8K4LNJS | KETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] | 1 | |
| polysorbate 60 | INACTIVE INGREDIENT | CAL22UVI4M | KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.] | 1 | |
| polysorbate 60 | INACTIVE INGREDIENT | CAL22UVI4M | KETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] | 1 | |
| polysorbate 60 | INACTIVE INGREDIENT | CAL22UVI4M | KETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP] | 1 | |
| polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.] | 1 | |
| polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | KETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP] | 1 | |
| polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | KETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] | 1 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | KETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP] | 1 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.] | 1 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | KETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] | 1 | |
| sorbitan monostearate | INACTIVE INGREDIENT | NVZ4I0H58X | KETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP] | 1 | |
| sorbitan monostearate | INACTIVE INGREDIENT | NVZ4I0H58X | KETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] | 1 | |
| sorbitan monostearate | INACTIVE INGREDIENT | NVZ4I0H58X | KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.] | 1 | |
| stearyl alcohol | INACTIVE INGREDIENT | 2KR89I4H1Y | KETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP] | 1 | |
| stearyl alcohol | INACTIVE INGREDIENT | 2KR89I4H1Y | KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.] | 1 | |
| stearyl alcohol | INACTIVE INGREDIENT | 2KR89I4H1Y | KETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | KETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP] | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.] | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | KETOCONAZOLE 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 |
|---|
| 51672-1298 | KETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | Current NDC, Legacy NDC, 6 package rows | 20240210_39b85d6a-9133-42e6-b7f8-58f045e9b9f0.zip |
| 51672-1298 | PODIATROLE (KETOCONAZOLE 2% AND UREA 20%) KIT [V2 PHARMA, LLC] | 1 | Current NDC, Legacy NDC | 20230219_ebd520d0-8069-490f-a0d7-356d1e7c3dfd.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51672-1298-1 | 51672129801 | 1 TUBE in 1 CARTON (51672-1298-1) / 15 g in 1 TUBE | 1 tube | 2002-12-18 | 0000-00-00 | No | No | Current |
| 51672-1298-2 | 51672129802 | 1 TUBE in 1 CARTON (51672-1298-2) / 30 g in 1 TUBE | 1 tube | 2002-12-18 | 0000-00-00 | No | No | Current |
| 51672-1298-3 | 51672129803 | 1 TUBE in 1 CARTON (51672-1298-3) / 60 g in 1 TUBE | 1 tube | 2002-12-18 | 0000-00-00 | No | No | Current |