Tadalafil
- Product NDC
- 27241-123
- 11-digit product format
- 272410123
- Labeler code
- 27241
- Product ID
- 27241-123_e21837f2-58d2-4fb1-87b3-f751b94312a9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tadalafil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Ajanta Pharma USA Inc.
- Application
- ANDA210392
- Marketing category
- ANDA
- Marketing start
- 2022-07-04
- Substance
- TADALAFIL
- Active strength
- 20 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 | 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 |
|---|
| 27241-123-02 | Tadalafil | 60 in 1 BOTTLE | TABLET | 60 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 27241-123 | TADALAFIL TABLET [AJANTA PHARMA USA INC.] | 7 | Current NDC, Legacy NDC, 1 package rows | 20230530_fceb8aaf-b4eb-4004-8ca4-f004eac6b314.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 |
|---|
| 27241-123-02 | 27241012302 | 60 TABLET in 1 BOTTLE (27241-123-02) | 60 tablet | 2022-07-04 | 0000-00-00 | No | No | Current |