Ketoconazole
- Product NDC
- 60429-020
- 11-digit product format
- 604290020
- Labeler code
- 60429
- Product ID
- 60429-020_43d1c0c3-2134-6533-e063-6394a90a6650
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketoconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Golden State Medical Supply, Inc.
- Application
- ANDA075319
- Marketing category
- ANDA
- Marketing start
- 1999-06-15
- Substance
- KETOCONAZOLE
- Active strength
- 200 mg/1
- 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 | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R9400W927I |
| Rxcui | 197853 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60429-020-01 | Ketoconazole | 100 in 1 BOTTLE | TABLET | 100 | | 13 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Ketoconazole | ACTIVE INGREDIENT | R9400W927I | KETOCONAZOLE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] | 4 | |
| Ketoconazole | ACTIVE MOIETY | R9400W927I | KETOCONAZOLE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | KETOCONAZOLE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] | 4 | |
| colloidal silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | KETOCONAZOLE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] | 4 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | KETOCONAZOLE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] | 4 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | KETOCONAZOLE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] | 4 | |
| povidone | INACTIVE INGREDIENT | FZ989GH94E | KETOCONAZOLE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] | 4 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | KETOCONAZOLE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60429-020 | KETOCONAZOLE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] | 12 | Current NDC, Legacy NDC, 1 package rows | 20240703_a9fc4618-4d87-47ef-ab3c-c9ffac3ba9b7.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 |
|---|
| 60429-020-01 | 60429002001 | 100 TABLET in 1 BOTTLE (60429-020-01) | 100 tablet | 2014-12-15 | 0000-00-00 | No | No | Current |