Tadalafil
- Product NDC
- 69238-1349
- 11-digit product format
- 692381349
- Labeler code
- 69238
- Product ID
- 69238-1349_5c6a682e-8bbe-4e9c-914c-148a5a0cb2a4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tadalafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA209744
- Marketing category
- ANDA
- Marketing start
- 2019-03-27
- 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 |
|---|
| 69238-1349-3 | Tadalafil | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69238-1349 | TADALAFIL TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC] | 7 | Current NDC, Legacy NDC, 1 package rows | 20250312_90f38460-62ad-492e-a3da-403d5a5a5d86.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 |
|---|
| 69238-1349-3 | 69238134903 | 30 TABLET, FILM COATED in 1 BOTTLE (69238-1349-3) | 2019-03-27 | 0000-00-00 | No | No | Current |