EXTINA
- Product NDC
- 0378-8136
- 11-digit product format
- 003788136
- Labeler code
- 0378
- Product ID
- 0378-8136_6082e3cc-c1da-4df0-9937-e9fe551ecc5d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ketoconazole
- Dosage form
- AEROSOL, FOAM
- Route
- TOPICAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- NDA021738
- Marketing category
- NDA
- Marketing start
- 2019-01-04
- 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
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-8136-01 | 00378813601 | 100 g in 1 CAN (0378-8136-01) | 100 g | 2019-01-04 | 0000-00-00 | No | No | Current |
| 0378-8136-50 | 00378813650 | 50 g in 1 CAN (0378-8136-50) | 50 g | 2019-01-04 | 0000-00-00 | No | No | Current |