Tadalafil
- Product NDC
- 68788-8153
- 11-digit product format
- 687888153
- Labeler code
- 68788
- Product ID
- 68788-8153_4677fe18-0da6-4c0e-989a-d77e4f228a58
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tadalafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA209167
- Marketing category
- ANDA
- Marketing start
- 2022-03-14
- Substance
- TADALAFIL
- Active strength
- 20 mg/1
- Pharmacologic classes
- Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tadalafil
- Listing expiration
- 2027-12-31
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 |
|---|
| 68788-8153-7 | Tadalafil | 7 in 1 BOTTLE | TABLET, FILM COATED | 7 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8153 | TADALAFIL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240816_affacb88-4af3-4ce9-961b-7fc37b169e9a.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 |
|---|
| 68788-8153-7 | 68788815307 | 7 TABLET, FILM COATED in 1 BOTTLE (68788-8153-7) | 2022-03-14 | 0000-00-00 | No | No | Current |