Tadalafil
- Product NDC
- 0378-6972
- 11-digit product format
- 003786972
- Labeler code
- 0378
- Product ID
- 0378-6972_364264a9-0704-496d-b7f8-df4090453cf1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tadalafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA206956
- Marketing category
- ANDA
- Marketing start
- 2019-05-14
- Marketing end
- 0000-00-00
- Substance
- TADALAFIL
- Active strength
- 10 mg/1
- Pharmacologic classes
- Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-6972-93 | 00378697293 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6972-93) | 2019-05-14 | 0000-00-00 | No | No | Current |