TADALAFIL
- Product NDC
- 68788-8465
- 11-digit product format
- 687888465
- Labeler code
- 68788
- Product ID
- 68788-8465_a2d04de6-0652-4040-9aa3-9575514262b8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tadalafil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA210609
- Marketing category
- ANDA
- Marketing start
- 2023-06-23
- 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 | 403957 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-8465-1 | TADALAFIL | 15 in 1 BOTTLE | TABLET | 15 | | 3 |
| 68788-8465-2 | TADALAFIL | 20 in 1 BOTTLE | TABLET | 20 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8465 | TADALAFIL TABLET [PREFERRED PHARMACEUTICALS INC.] | 2 | Current NDC, 2 package rows | 20240816_66e24ced-0008-40cb-b242-9d9add1f665c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8465-1 | 68788846501 | 15 TABLET in 1 BOTTLE (68788-8465-1) | 15 tablet | 2023-06-23 | No | No | Historical |
| 68788-8465-2 | 68788846502 | 20 TABLET in 1 BOTTLE (68788-8465-2) | 20 tablet | 2023-06-23 | No | No | Historical |