TADALAFIL
- Product NDC
- 43547-051
- 11-digit product format
- 435470051
- Labeler code
- 43547
- Product ID
- 43547-051_b7c42c71-e6fa-4e5d-afe3-617dc236a69f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tadalafil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Solco Healthcare US, LLC
- Application
- ANDA210609
- Marketing category
- ANDA
- Marketing start
- 2022-01-18
- 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 | 402019, 403957, 484814, 757707 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43547-051-03 | TADALAFIL | 30 in 1 BOTTLE | TABLET | 30 | | 6 |
| 43547-051-11 | TADALAFIL | 1000 in 1 BOTTLE | TABLET | 1000 | | 6 |
| 43547-051-50 | TADALAFIL | 500 in 1 BOTTLE | TABLET | 500 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43547-051 | TADALAFIL TABLET [SOLCO HEALTHCARE US, LLC] | 2 | Current NDC, Legacy NDC, 3 package rows | 20230908_05640a4d-afb7-42ae-a5bb-77dbc8412356.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 |
|---|
| 43547-051-03 | 43547005103 | 30 TABLET in 1 BOTTLE (43547-051-03) | 30 tablet | 2022-01-18 | 0000-00-00 | No | No | Current |
| 43547-051-11 | 43547005111 | 1000 TABLET in 1 BOTTLE (43547-051-11) | 1000 tablet | 2022-01-18 | | No | No | Current |
| 43547-051-50 | 43547005150 | 500 TABLET in 1 BOTTLE (43547-051-50) | 500 tablet | 2022-01-18 | 0000-00-00 | No | No | Current |