Ketoconazole
- Product NDC
- 68151-2713
- 11-digit product format
- 681512713
- Labeler code
- 68151
- Product ID
- 68151-2713_c723f7b1-bbfb-472c-a971-a7a81e621808
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketoconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Carilion Materials Management
- Application
- ANDA075273
- Marketing category
- ANDA
- Marketing start
- 1999-06-15
- Marketing end
- 0000-00-00
- 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
- E
- Listing certified through
- 2018-12-31
- 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68151-2713-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c751-f424-e053-dadaa90a57ce | KETOCONAZOLE TABLETS USP, 200 mg Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68151-2713-0 | Ketoconazole | 1 in 1 PACKAGE | TABLET | 1 | 5 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| KETOCONAZOLE | ACTIVE INGREDIENT | R9400W927I | KETOCONAZOLE TABLET [CARILION MATERIALS MANAGEMENT] | 2 | |
| KETOCONAZOLE | ACTIVE MOIETY | R9400W927I | KETOCONAZOLE TABLET [CARILION MATERIALS MANAGEMENT] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | KETOCONAZOLE TABLET [CARILION MATERIALS MANAGEMENT] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | KETOCONAZOLE TABLET [CARILION MATERIALS MANAGEMENT] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | KETOCONAZOLE TABLET [CARILION MATERIALS MANAGEMENT] | 2 | |
| POVIDONE K29/32 | INACTIVE INGREDIENT | 390RMW2PEQ | KETOCONAZOLE TABLET [CARILION MATERIALS MANAGEMENT] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | KETOCONAZOLE TABLET [CARILION MATERIALS MANAGEMENT] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | KETOCONAZOLE TABLET [CARILION MATERIALS MANAGEMENT] | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68151-2713 | KETOCONAZOLE TABLET [CARILION MATERIALS MANAGEMENT] | 5 | Legacy NDC, 1 package rows | 20171227_be550113-f75c-4aec-86ed-c4a0c1a6f704.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197853 | ketoconazole 200 MG Oral Tablet | PSN | be550113-f75c-4aec-86ed-c4a0c1a6f704 | 5 |
| 197853 | ketoconazole 200 MG Oral Tablet | SCD | be550113-f75c-4aec-86ed-c4a0c1a6f704 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 68151-2713-0 | 68151271300 | 1 in 1 PACKAGE | Historical |