tadalafil
- Product NDC
- 35573-462
- 11-digit product format
- 355730462
- Labeler code
- 35573
- Product ID
- 35573-462_da1eee2b-ebe6-4af3-ad52-2b349a360a9a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tadalafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Burel Pharmaceuticals, LLC
- Application
- ANDA215556
- Marketing category
- ANDA
- Marketing start
- 2023-04-01
- Substance
- TADALAFIL
- Active strength
- 10 mg/1
- Pharmacologic classes
- Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- tadalafil
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TADALAFIL | 10 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 |
|---|
| 35573-462-30 | tadalafil | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 35573-462 | TADALAFIL TABLET, FILM COATED [BUREL PHARMACEUTICALS, LLC] | 3 | Current NDC, 1 package rows | 20230401_a2e7f393-5cfc-45e5-b87d-9e8abc8e4355.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 35573-462-30 | 35573046230 | 30 TABLET, FILM COATED in 1 BOTTLE (35573-462-30) | 2023-04-01 | No | No | Historical |