Tadalafil
- Product NDC
- 71610-461
- 11-digit product format
- 716100461
- Labeler code
- 71610
- Product ID
- 71610-461_b5c51223-f994-41aa-8478-ed13dc51a908
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tadalafil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA209654
- Marketing category
- ANDA
- Marketing start
- 2019-03-26
- Substance
- TADALAFIL
- Active strength
- 5 mg/1
- Pharmacologic classes
- Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tadalafil
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TADALAFIL | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 742SXX0ICT |
| Rxcui | 403957 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71610-461-08 | Tadalafil | 8 in 1 BOTTLE | TABLET | 8 | | 1 |
| 71610-461-11 | Tadalafil | 48 in 1 BOTTLE | TABLET | 48 | | 1 |
| 71610-461-23 | Tadalafil | 16 in 1 BOTTLE | TABLET | 16 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71610-461 | TADALAFIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Current NDC, Legacy NDC, 3 package rows | 20201003_36350106-98bc-41fc-bede-8be5e6f54a8a.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 |
|---|
| 71610-461-08 | 71610046108 | 8 TABLET in 1 BOTTLE (71610-461-08) | 8 tablet | 2020-09-04 | 0000-00-00 | No | No | Current |
| 71610-461-11 | 71610046111 | 48 TABLET in 1 BOTTLE (71610-461-11) | 48 tablet | 2020-09-04 | 0000-00-00 | No | No | Current |
| 71610-461-23 | 71610046123 | 16 TABLET in 1 BOTTLE (71610-461-23) | 16 tablet | 2020-09-04 | 0000-00-00 | No | No | Current |