Ketoconazole
- Product NDC
- 21695-562
- 11-digit product format
- 216950562
- Labeler code
- 21695
- Product ID
- 21695-562_ec308fcf-ec39-43af-97e3-98aa8ab997f4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketoconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA075319
- 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
- 2017-12-31
- 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 |
|---|---|---|---|---|---|
| 21695-562-30 | 2019-09-24 | C162847 | 48780-1 | 934fe258-49ec-48b1-e053-8cdaa90a720a | KETOCONAZOLE TABLETS USP, 200 mg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-562-30 | Ketoconazole | 30 in 1 BOTTLE | TABLET | 30 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-562-30 | EA - Each | 21695-562 | 15c1789e-4287-4f7a-bdbd-0c1b45b9ad10 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Ketoconazole | ACTIVE INGREDIENT | R9400W927I | KETOCONAZOLE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| Ketoconazole | ACTIVE MOIETY | R9400W927I | KETOCONAZOLE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | KETOCONAZOLE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | KETOCONAZOLE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | KETOCONAZOLE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| povidone | INACTIVE INGREDIENT | FZ989GH94E | KETOCONAZOLE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | KETOCONAZOLE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | KETOCONAZOLE TABLET [REBEL DISTRIBUTORS CORP] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197853 | ketoconazole 200 MG Oral Tablet | PSN | ec308fcf-ec39-43af-97e3-98aa8ab997f4 | 1 |
| 197853 | ketoconazole 200 MG Oral Tablet | SCD | ec308fcf-ec39-43af-97e3-98aa8ab997f4 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 21695-562-30 | 21695056230 | 30 in 1 BOTTLE | Historical |