TADALAFIL
- Product NDC
- 71335-2626
- 11-digit product format
- 713352626
- Labeler code
- 71335
- Product ID
- 71335-2626_99f2e025-90d4-47af-9d38-5bd05a8eb29f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tadalafil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA210609
- Marketing category
- ANDA
- Marketing start
- 2022-01-18
- 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 | 484814 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2626-1 | 71335262601 | 30 TABLET in 1 BOTTLE (71335-2626-1) | 30 tablet | 2025-06-02 | No | No | Historical |
| 71335-2626-2 | 71335262602 | 10 TABLET in 1 BOTTLE (71335-2626-2) | 10 tablet | 2025-06-02 | No | No | Historical |
| 71335-2626-3 | 71335262603 | 60 TABLET in 1 BOTTLE (71335-2626-3) | 60 tablet | 2025-06-02 | No | No | Historical |
| 71335-2626-4 | 71335262604 | 90 TABLET in 1 BOTTLE (71335-2626-4) | 90 tablet | 2025-06-02 | No | No | Historical |
| 71335-2626-5 | 71335262605 | 20 TABLET in 1 BOTTLE (71335-2626-5) | 20 tablet | 2025-06-02 | No | No | Historical |
| 71335-2626-6 | 71335262606 | 6 TABLET in 1 BOTTLE (71335-2626-6) | 6 tablet | 2025-06-02 | No | No | Historical |