Tadalafil
- Product NDC
- 80425-0443
- 11-digit product format
- 804250443
- Labeler code
- 80425
- Product ID
- 80425-0443_248a470e-c977-fb5c-e063-6394a90abb66
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tadalafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Advanced Rx of Tennessee, LLC
- Application
- ANDA210420
- Marketing category
- ANDA
- Marketing start
- 2024-10-15
- 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 | 402019 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80425-0443-1 | Tadalafil | 7 in 1 BOTTLE | TABLET, FILM COATED | 7 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80425-0443 | TADALAFIL TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC] | 1 | Current NDC, 1 package rows | 20241017_248a4705-1403-e94a-e063-6294a90a3544.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0443-1 | 80425044301 | 7 TABLET, FILM COATED in 1 BOTTLE (80425-0443-1) | 2024-10-15 | No | No | Historical |