Tadalafil
- Product NDC
- 68462-780
- 11-digit product format
- 684620780
- Labeler code
- 68462
- Product ID
- 68462-780_ab4a5677-ee15-46d1-888c-58727a949aa5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tadalafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- GLENMARK PHARMACEUTICALS INC., USA
- Application
- ANDA210716
- Marketing category
- ANDA
- Marketing start
- 2020-12-29
- Marketing end
- 0000-00-00
- Substance
- TADALAFIL
- Active strength
- 5 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 | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68462-780-13 | 68462078013 | 2 BLISTER PACK in 1 CARTON (68462-780-13) > 15 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2020-12-29 | 0000-00-00 | No | No | Current |
| 68462-780-30 | 68462078030 | 30 TABLET, FILM COATED in 1 BOTTLE (68462-780-30) | 2020-12-29 | 0000-00-00 | No | No | Current |