TADALAFIL
- Product NDC
- 68071-3800
- 11-digit product format
- 680713800
- Labeler code
- 68071
- Product ID
- 68071-3800_2eae8155-aea4-6b63-e063-6394a90a55b3
- 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
- 2.5 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 | 2.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 742SXX0ICT |
| Rxcui | 757707 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3800-3 | TADALAFIL | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3800 | TADALAFIL TABLET [NUCARE PHARMACEUTICALS, INC.] | 1 | Current NDC, 1 package rows | 20250224_2eae8756-5c7f-2545-e063-6294a90a6d52.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 |
|---|
| 68071-3800-3 | 68071380003 | 30 TABLET in 1 BOTTLE (68071-3800-3) | 30 tablet | 2025-02-21 | No | No | Historical |