Tadalafil
- Product NDC
- 82968-002
- 11-digit product format
- 829680002
- Labeler code
- 82968
- Product ID
- 82968-002_464c2d55-32ca-db41-e063-6294a90a9103
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tadalafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED
- Application
- ANDA217606
- Marketing category
- ANDA
- Marketing start
- 2024-08-21
- 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 | 402019, 403957, 484814, 757707 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82968-002-01 | Tadalafil | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
| 82968-002-02 | Tadalafil | 2 in 1 CARTON | TABLET, FILM COATED | 2 | | 2 |
| 82968-002-02 | Tadalafil | 15 in 1 BLISTER PACK | TABLET, FILM COATED | 15 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82968-002 | TADALAFIL TABLET, FILM COATED [FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED] | 1 | Current NDC, 3 package rows | 20240822_0ea97208-5afc-4943-b35c-ea850203a794.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 |
|---|
| 82968-002-01 | 82968000201 | 30 TABLET, FILM COATED in 1 BOTTLE (82968-002-01) | | 2024-08-21 | No | No | Current |
| 82968-002-02 | 82968000202 | 2 BLISTER PACK in 1 CARTON (82968-002-02) / 15 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2024-08-21 | No | No | Current |