Ketoconazole
- Product NDC
- 43063-036
- 11-digit product format
- 430630036
- Labeler code
- 43063
- Product ID
- 43063-036_adba9c89-8e63-74be-e053-2a95a90a7f85
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ketoconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA075597
- Marketing category
- ANDA
- Marketing start
- 1999-12-23
- 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
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43063-036-30 | 43063003630 | 30 TABLET in 1 BOTTLE, PLASTIC (43063-036-30) | 30 tablet | 2000-02-29 | 0000-00-00 | No | No | Current |