TADALAFIL
- Product NDC
- 68071-3598
- 11-digit product format
- 680713598
- Labeler code
- 68071
- Product ID
- 68071-3598_1bfa0b78-af77-374d-e063-6394a90a944b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tadalafil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc..
- Application
- ANDA210609
- Marketing category
- ANDA
- Marketing start
- 2022-01-18
- 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 |
|---|
| 68071-3598-1 | TADALAFIL | 10 in 1 BOTTLE | TABLET | 10 | | 2 |
| 68071-3598-6 | TADALAFIL | 60 in 1 BOTTLE | TABLET | 60 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3598 | TADALAFIL TABLET [NUCARE PHARMACEUTICALS,INC..] | 2 | Current NDC, 2 package rows | 20240731_16f13179-7c87-aa6c-e063-6294a90a93eb.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 |
|---|
| 68071-3598-1 | 68071359801 | 10 TABLET in 1 BOTTLE (68071-3598-1) | 10 tablet | 2024-06-28 | No | No | Current |
| 68071-3598-6 | 68071359806 | 60 TABLET in 1 BOTTLE (68071-3598-6) | 60 tablet | 2024-04-25 | No | No | Current |