Ketoconazole
- Product NDC
- 0378-0261
- 11-digit product format
- 003780261
- Labeler code
- 0378
- Product ID
- 0378-0261_15ce77ae-5a58-49dd-9833-72aaca3586fa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ketoconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA075597
- Marketing category
- ANDA
- Marketing start
- 1999-12-23
- Marketing end
- 2021-03-31
- 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
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fd9dd88b-5db8-6370-b47e-37f6c9b1c5d5 | Product name | 2 | 20250331 |
| 1e18fb2e-aeff-8efe-93be-5a5f7be8faa2 | Product name | 2 | 20211209 |
| 8bc3781f-20ed-678b-44a7-a981e693c65f | Product name | 2 | 20211209 |
| ff3a8c91-648c-300b-467e-10703f514265 | Product name | 2 | 20180809 |
| 152a96a4-36b6-f5b1-d4e6-9a500e06bbf3 | Product name | 1 | 20140508 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0378-0261-01 | EA - Each | 0378-0261 | 035c8313-41af-4526-bbd1-564a98445a7a | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| KETOCONAZOLE | ACTIVE INGREDIENT | R9400W927I | KETOCONAZOLE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| KETOCONAZOLE | ACTIVE MOIETY | R9400W927I | KETOCONAZOLE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | KETOCONAZOLE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | KETOCONAZOLE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | KETOCONAZOLE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | KETOCONAZOLE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | KETOCONAZOLE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | KETOCONAZOLE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197853 | ketoconazole 200 MG Oral Tablet | PSN | e63b2fa8-84db-4d42-8659-1905a29bbdb7 | 5 |
| 197853 | ketoconazole 200 MG Oral Tablet | SCD | e63b2fa8-84db-4d42-8659-1905a29bbdb7 | 5 |
| 197853 | ketoconazole 200 MG Oral Tablet | PSN | 70ec9dd0-8c93-4ac5-b872-f426c9ae4b98 | 1 |
| 197853 | ketoconazole 200 MG Oral Tablet | SCD | 70ec9dd0-8c93-4ac5-b872-f426c9ae4b98 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0378-0261-01 | 00378026101 | 100 TABLET in 1 BOTTLE, PLASTIC (0378-0261-01) | 100 tablet | 1999-12-23 | 2021-03-31 | No | No | Current |