Ketoconazole
- Product NDC
- 68258-3998
- 11-digit product format
- 682583998
- Labeler code
- 68258
- Product ID
- 68258-3998_3f184545-ae45-4fcb-a640-930401accb0b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketoconazole
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Dispensing Solutions, Inc.
- Application
- ANDA075638
- Marketing category
- ANDA
- Marketing start
- 2002-12-18
- Marketing end
- 0000-00-00
- 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
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68258-3998-3 | Ketoconazole | 30 g in 1 TUBE | CREAM | 30 | | 1 |
| 68258-3998-3 | Ketoconazole | 1 in 1 CARTON | CREAM | 1 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Ketoconazole | ACTIVE INGREDIENT | R9400W927I | KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.] | 1 | |
| Ketoconazole | ACTIVE MOIETY | R9400W927I | KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.] | 1 | |
| butylated hydroxyanisole | INACTIVE INGREDIENT | REK4960K2U | KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.] | 1 | |
| cetyl alcohol | INACTIVE INGREDIENT | 936JST6JCN | KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.] | 1 | |
| isopropyl myristate | INACTIVE INGREDIENT | 0RE8K4LNJS | KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.] | 1 | |
| polysorbate 60 | INACTIVE INGREDIENT | CAL22UVI4M | KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.] | 1 | |
| polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.] | 1 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.] | 1 | |
| sorbitan monostearate | INACTIVE INGREDIENT | NVZ4I0H58X | KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.] | 1 | |
| stearyl alcohol | INACTIVE INGREDIENT | 2KR89I4H1Y | KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.] | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68258-3998 | KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.] | 1 | Legacy NDC, 2 package rows | 20120313_c23a27a2-e2e5-4a93-a96a-1f0248286f43.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 68258-3998-3 | 68258399803 | 30 g in 1 TUBE | 30 g | Historical |