Tadalafil
- Product NDC
- 62332-177
- 11-digit product format
- 623320177
- Labeler code
- 62332
- Product ID
- 62332-177_76b22a5c-175e-433e-bd1e-5fefb0a78d5f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tadalafil
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Inc.
- Application
- ANDA204809
- Marketing category
- ANDA
- Marketing start
- 2019-03-26
- Substance
- TADALAFIL
- Active strength
- 2.5 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 | 2.5 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 |
|---|
| 62332-177-15 | Tadalafil | 30 in 1 CARTON | TABLET, COATED | 30 | | 14 |
| 62332-177-30 | Tadalafil | 30 in 1 BOTTLE | TABLET, COATED | 30 | | 14 |
| 62332-177-71 | Tadalafil | 500 in 1 BOTTLE | TABLET, COATED | 500 | | 14 |
| 62332-177-91 | Tadalafil | 1000 in 1 BOTTLE | TABLET, COATED | 1000 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62332-177 | TADALAFIL TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.] | 14 | Current NDC, Legacy NDC, 4 package rows | 20250430_abcb2cda-9b3f-45f6-ad5f-c2370b0dd114.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 62332-177-15 | 62332017715 | 30 TABLET, COATED in 1 CARTON (62332-177-15) | 2019-03-26 | 0000-00-00 | No | No | Current |
| 62332-177-30 | 62332017730 | 30 TABLET, COATED in 1 BOTTLE (62332-177-30) | 2021-12-03 | 0000-00-00 | No | No | Current |
| 62332-177-71 | 62332017771 | 500 TABLET, COATED in 1 BOTTLE (62332-177-71) | 2024-08-02 | | No | No | Current |
| 62332-177-91 | 62332017791 | 1000 TABLET, COATED in 1 BOTTLE (62332-177-91) | 2024-08-02 | | No | No | Current |