Tadalafil
- Product NDC
- 0480-2309
- 11-digit product format
- 004802309
- Labeler code
- 0480
- Product ID
- 0480-2309_8406079c-f302-43d9-a7d7-5e790bde8c85
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tadalafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals, Inc.
- Application
- ANDA205885
- Marketing category
- ANDA
- Marketing start
- 2024-01-16
- Marketing end
- 2027-02-28
- Substance
- TADALAFIL
- Active strength
- 5 mg/1
- Pharmacologic classes
- Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tadalafil
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TADALAFIL | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 742SXX0ICT |
| Rxcui | 402019, 403957, 484814 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0480-2309-56 | 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 |
|---|
| 0480-2309 | TADALAFIL TABLET, FILM COATED [TEVA PHARMACEUTICALS, INC.] | 6 | Current NDC, 1 package rows | 20250519_3ad14d63-42e7-493f-b56c-e02a4fd139f7.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 |
|---|
| 0480-2309-56 | 00480230956 | 30 TABLET, FILM COATED in 1 BOTTLE (0480-2309-56) | 2024-01-16 | 2027-02-28 | No | No | Historical |