TADALAFIL
- Product NDC
- 13668-581
- 11-digit product format
- 136680581
- Labeler code
- 13668
- Product ID
- 13668-581_1f85153f-5d3a-40d8-8570-1d969f4efa3c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TADALAFIL
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Torrent Pharmaceuticals Limited
- Application
- ANDA212062
- Marketing category
- ANDA
- Marketing start
- 2019-03-26
- Substance
- TADALAFIL
- Active strength
- 20 mg/1
- Pharmacologic classes
- Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TADALAFIL
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TADALAFIL | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 742SXX0ICT |
| Rxcui | 2123194 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 13668-581-30 | TADALAFIL | 30 in 1 BOTTLE | TABLET | 30 | | 13 |
| 13668-581-60 | TADALAFIL | 60 in 1 BOTTLE | TABLET | 60 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 13668-581 | TADALAFIL TABLET [TORRENT PHARMACEUTICALS LIMITED] | 12 | Current NDC, Legacy NDC, 2 package rows | 20240711_88132351-7fee-47ef-8007-ef2777543299.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 13668-581-05 | 13668058105 | 500 TABLET in 1 BOTTLE (13668-581-05) | 500 tablet | 2019-03-26 | 0000-00-00 | No | No | Current |
| 13668-581-30 | 13668058130 | 30 TABLET in 1 BOTTLE (13668-581-30) | 30 tablet | 2019-03-26 | 0000-00-00 | No | No | Current |
| 13668-581-60 | 13668058160 | 60 TABLET in 1 BOTTLE (13668-581-60) | 60 tablet | 2020-11-21 | 0000-00-00 | No | No | Current |
| 13668-581-71 | 13668058171 | 10 TABLET in 1 BLISTER PACK (13668-581-71) | 10 tablet | 2019-03-26 | 0000-00-00 | No | No | Current |
| 13668-581-74 | 13668058174 | 100 TABLET in 1 CARTON (13668-581-74) | 100 tablet | 2019-03-26 | 0000-00-00 | No | No | Current |