ketoconazole
- Product NDC
- 0168-0099
- 11-digit product format
- 001680099
- Labeler code
- 0168
- Product ID
- 0168-0099_6eaf555f-3e9c-4811-ae1f-66afda8b2b11
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ketoconazole
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
- Application
- ANDA076294
- Marketing category
- ANDA
- Marketing start
- 2004-04-28
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ketoconazole
- Listing expiration
- 2027-12-31
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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ketoconazole | ACTIVE INGREDIENT | R9400W927I | KETOCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 3 | |
| ketoconazole | ACTIVE MOIETY | R9400W927I | KETOCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 3 | |
| cetyl alcohol | INACTIVE INGREDIENT | 936JST6JCN | KETOCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 3 | |
| isopropyl myristate | INACTIVE INGREDIENT | 0RE8K4LNJS | KETOCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 3 | |
| polysorbate 60 | INACTIVE INGREDIENT | CAL22UVI4M | KETOCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 3 | |
| polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | KETOCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 3 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | KETOCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 3 | |
| sodium sulfite | INACTIVE INGREDIENT | VTK01UQK3G | KETOCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 3 | |
| sorbitan monostearate | INACTIVE INGREDIENT | NVZ4I0H58X | KETOCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 3 | |
| stearyl alcohol | INACTIVE INGREDIENT | 2KR89I4H1Y | KETOCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 3 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | KETOCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 3 | |
| KETOCONAZOLE | ACTIVE INGREDIENT | R9400W927I | KETOCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| KETOCONAZOLE | ACTIVE INGREDIENT | R9400W927I | KETOCONAZOLE CREAM [DIRECT RX] | 1 | |
| KETOCONAZOLE | ACTIVE MOIETY | R9400W927I | KETOCONAZOLE CREAM [DIRECT RX] | 1 | |
| KETOCONAZOLE | ACTIVE MOIETY | R9400W927I | KETOCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| cetyl alcohol | INACTIVE INGREDIENT | 936JST6JCN | KETOCONAZOLE CREAM [DIRECT RX] | 1 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | KETOCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| ISOPROPYL MYRISTATE | INACTIVE INGREDIENT | 0RE8K4LNJS | KETOCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| isopropyl myristate | INACTIVE INGREDIENT | 0RE8K4LNJS | KETOCONAZOLE CREAM [DIRECT RX] | 1 | |
| POLYSORBATE 60 | INACTIVE INGREDIENT | CAL22UVI4M | KETOCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| polysorbate 60 | INACTIVE INGREDIENT | CAL22UVI4M | KETOCONAZOLE CREAM [DIRECT RX] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | KETOCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | KETOCONAZOLE CREAM [DIRECT RX] | 1 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | KETOCONAZOLE CREAM [DIRECT RX] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | KETOCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| sodium sulfite | INACTIVE INGREDIENT | VTK01UQK3G | KETOCONAZOLE CREAM [DIRECT RX] | 1 | |
| SODIUM SULFITE | INACTIVE INGREDIENT | VTK01UQK3G | KETOCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| SORBITAN MONOSTEARATE | INACTIVE INGREDIENT | NVZ4I0H58X | KETOCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| sorbitan monostearate | INACTIVE INGREDIENT | NVZ4I0H58X | KETOCONAZOLE CREAM [DIRECT RX] | 1 | |
| STEARYL ALCOHOL | INACTIVE INGREDIENT | 2KR89I4H1Y | KETOCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| stearyl alcohol | INACTIVE INGREDIENT | 2KR89I4H1Y | KETOCONAZOLE CREAM [DIRECT RX] | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | KETOCONAZOLE CREAM [DIRECT RX] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | KETOCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0168-0099 | KETOCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 7 | Current NDC, Legacy NDC, 6 package rows | 20211020_cad7c647-34a9-4e4e-83b3-8d78e58f588f.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 |
|---|
| 0168-0099-15 | 00168009915 | 1 TUBE in 1 CARTON (0168-0099-15) / 15 g in 1 TUBE | 1 tube | 2004-04-28 | 0000-00-00 | No | No | Current |
| 0168-0099-30 | 00168009930 | 1 TUBE in 1 CARTON (0168-0099-30) / 30 g in 1 TUBE | 1 tube | 2004-04-28 | 0000-00-00 | No | No | Current |
| 0168-0099-60 | 00168009960 | 1 TUBE in 1 CARTON (0168-0099-60) / 60 g in 1 TUBE | 1 tube | 2004-04-28 | 0000-00-00 | No | No | Current |