Tadalafil
- Product NDC
- 75834-247
- 11-digit product format
- 758340247
- Labeler code
- 75834
- Product ID
- 75834-247_45810509-9e49-3ee2-e063-6394a90aa944
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tadalafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NIVAGEN PHARMACEUTICALS, INC.
- Application
- ANDA211298
- Marketing category
- ANDA
- Marketing start
- 2020-11-02
- 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 | 402019, 403957, 484814, 757707 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 75834-247-01 | Tadalafil | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 10 |
| 75834-247-15 | Tadalafil | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 10 |
| 75834-247-30 | Tadalafil | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 75834-247 | TADALAFIL TABLET, FILM COATED [NIVAGEN PHARMACEUTICALS, INC.] | 9 | Current NDC, Legacy NDC, 3 package rows | 20241225_ca1d46e3-ad9b-48c7-bb7f-63ee678ccf7a.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 |
|---|
| 75834-247-01 | 75834024701 | 1000 TABLET, FILM COATED in 1 BOTTLE (75834-247-01) | 2020-11-02 | 0000-00-00 | No | No | Current |
| 75834-247-15 | 75834024715 | 30 TABLET, FILM COATED in 1 BLISTER PACK (75834-247-15) | 2020-11-02 | 0000-00-00 | No | No | Current |
| 75834-247-30 | 75834024730 | 30 TABLET, FILM COATED in 1 BOTTLE (75834-247-30) | 2020-11-02 | 0000-00-00 | No | No | Current |