Tadalafil
- Product NDC
- 27241-113
- 11-digit product format
- 272410113
- Labeler code
- 27241
- Product ID
- 27241-113_4e9e209a-9f87-41cb-a7ac-a1fbf5412995
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tadalafil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Ajanta Pharma USA Inc.
- Application
- ANDA209654
- Marketing category
- ANDA
- Marketing start
- 2019-03-26
- Substance
- TADALAFIL
- Active strength
- 10 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 | 10 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 |
|---|
| 27241-113-03 | Tadalafil | 30 in 1 BOTTLE | TABLET | 30 | | 12 |
| 27241-113-05 | Tadalafil | 500 in 1 BOTTLE | TABLET | 500 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 27241-113 | TADALAFIL TABLET [AJANTA PHARMA USA INC.] | 11 | Current NDC, Legacy NDC, 2 package rows | 20230523_7e4cdac1-42cc-4038-a86b-4890962ed806.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 |
|---|
| 27241-113-03 | 27241011303 | 30 TABLET in 1 BOTTLE (27241-113-03) | 30 tablet | 2019-03-26 | 0000-00-00 | No | No | Current |
| 27241-113-05 | 27241011305 | 500 TABLET in 1 BOTTLE (27241-113-05) | 500 tablet | 2020-06-17 | 0000-00-00 | No | No | Current |