Ketoconazole
- Product NDC
- 70518-0915
- 11-digit product format
- 705180915
- Labeler code
- 70518
- Product ID
- 70518-0915_ebcb35a6-7cb0-69e3-e053-2995a90ae31a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketoconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA075319
- Marketing category
- ANDA
- Marketing start
- 2017-12-20
- 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
- 2023-12-31
- 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 |
|---|
| 70518-0915-1 | 70518091501 | 7 TABLET in 1 BOTTLE, PLASTIC (70518-0915-1) | 7 tablet | 2018-02-10 | 0000-00-00 | No | No | Current |