Ketoconazole
- Product NDC
- 63629-8819
- 11-digit product format
- 636298819
- Labeler code
- 63629
- Product ID
- 63629-8819_d29922c6-7e4f-493c-97a7-182e7f415deb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketoconazole
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA075581
- Marketing category
- ANDA
- Marketing start
- 2019-02-08
- 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#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63629-8819-1 | Ketoconazole | 15 g in 1 TUBE | CREAM | 15 | | 102 |
| 63629-8819-1 | Ketoconazole | 1 in 1 CARTON | CREAM | 1 | | 102 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-8819 | KETOCONAZOLE CREAM [BRYANT RANCH PREPACK] | 102 | Current NDC, Legacy NDC, 2 package rows | 20240113_dc635682-170d-46ad-a9ba-6a75c6e0950e.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 |
|---|
| 63629-8819-1 | 63629881901 | 1 TUBE in 1 CARTON (63629-8819-1) / 15 g in 1 TUBE | 1 tube | 2021-09-10 | 0000-00-00 | No | No | Current |