ketoconazole
- Product NDC
- 70518-1637
- 11-digit product format
- 705181637
- Labeler code
- 70518
- Product ID
- 70518-1637_9618003a-98c0-ed31-e053-2995a90a896a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ketoconazole
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA076294
- Marketing category
- ANDA
- Marketing start
- 2018-11-06
- Marketing end
- 0000-00-00
- Substance
- KETOCONAZOLE
- Active strength
- 20 mg/g
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-1637 | KETOCONAZOLE CREAM [REMEDYREPACK INC.] | 7 | Legacy NDC | 20250226_c394914b-2334-418e-bf86-9f9100323717.zip |