Tadalafil
- Product NDC
- 46708-178
- 11-digit product format
- 467080178
- Labeler code
- 46708
- Product ID
- 46708-178_53d81162-1774-48a1-b19b-f2b0e2d1020a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tadalafil
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA204809
- Marketing category
- ANDA
- Marketing start
- 2019-03-26
- Substance
- TADALAFIL
- Active strength
- 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 | 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 |
|---|
| 46708-178-15 | Tadalafil | 30 in 1 CARTON | TABLET, COATED | 30 | | 5 |
| 46708-178-30 | Tadalafil | 30 in 1 BOTTLE | TABLET, COATED | 30 | | 5 |
| 46708-178-71 | Tadalafil | 500 in 1 BOTTLE | TABLET, COATED | 500 | | 5 |
| 46708-178-91 | Tadalafil | 1000 in 1 BOTTLE | TABLET, COATED | 1000 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-178 | TADALAFIL TABLET, COATED [ALEMBIC PHARMACEUTICALS LIMITED] | 5 | Current NDC, Legacy NDC, 4 package rows | 20240906_741102c1-8809-44d4-9098-3dc8c0604764.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 |
|---|
| 46708-178-15 | 46708017815 | 30 TABLET, COATED in 1 CARTON (46708-178-15) | 2019-03-26 | 0000-00-00 | No | No | Current |
| 46708-178-30 | 46708017830 | 30 TABLET, COATED in 1 BOTTLE (46708-178-30) | 2019-03-26 | 0000-00-00 | No | No | Current |
| 46708-178-71 | 46708017871 | 500 TABLET, COATED in 1 BOTTLE (46708-178-71) | 2024-08-02 | | No | No | Current |
| 46708-178-91 | 46708017891 | 1000 TABLET, COATED in 1 BOTTLE (46708-178-91) | 2024-08-02 | | No | No | Current |