Tadalafil
- Product NDC
- 33342-267
- 11-digit product format
- 333420267
- Labeler code
- 33342
- Product ID
- 33342-267_1bc04765-18de-40fc-a680-fbe55aad1cf2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tadalafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA207244
- Marketing category
- ANDA
- Marketing start
- 2019-10-08
- 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 | 402019, 403957, 484814, 757707 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 33342-267-07 | Tadalafil | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
| 33342-267-44 | Tadalafil | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 33342-267 | TADALAFIL TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 3 | Current NDC, Legacy NDC, 2 package rows | 20250323_4348b7db-e5b2-4e87-8cdd-674797a18890.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 |
|---|
| 33342-267-07 | 33342026707 | 30 TABLET, FILM COATED in 1 BOTTLE (33342-267-07) | 2019-10-08 | 0000-00-00 | No | No | Current |
| 33342-267-44 | 33342026744 | 1000 TABLET, FILM COATED in 1 BOTTLE (33342-267-44) | 2025-04-17 | | No | No | Historical |