TADALAFIL
- Product NDC
- 43547-031
- 11-digit product format
- 435470031
- Labeler code
- 43547
- Product ID
- 43547-031_bdb087ff-a428-434e-b23b-0437f8672219
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tadalafil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Solco Healthcare US, LLC
- Application
- ANDA210609
- Marketing category
- ANDA
- Marketing start
- 2024-11-27
- 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 | 402019, 403957, 484814, 757707 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43547-031-03 | TADALAFIL | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
| 43547-031-50 | TADALAFIL | 500 in 1 BOTTLE | TABLET | 500 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43547-031 | TADALAFIL TABLET [SOLCO HEALTHCARE US, LLC] | 1 | Current NDC, 2 package rows | 20250302_491cb72b-71f2-4df9-99f8-c02d93500103.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 43547-031-03 | 43547003103 | 30 TABLET in 1 BOTTLE (43547-031-03) | 30 tablet | 2024-11-27 | No | No | Current |
| 43547-031-50 | 43547003150 | 500 TABLET in 1 BOTTLE (43547-031-50) | 500 tablet | 2024-11-27 | No | No | Current |