Tadalafil is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Burel Pharma. The primary component is Tadalafil.
| Product ID | 35573-411_02e6bb57-40dd-46c8-b146-3a85b64a17cd |
| NDC | 35573-411 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Tadalafil |
| Generic Name | Tadalafil |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2019-03-26 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA206285 |
| Labeler Name | Burel Pharma |
| Substance Name | TADALAFIL |
| Active Ingredient Strength | 10 mg/1 |
| Pharm Classes | Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2019-03-26 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA206285 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-03-26 |
| Ingredient | Strength |
|---|---|
| TADALAFIL | 10 mg/1 |
| SPL SET ID: | 13fd74e1-4120-4b24-aca9-46d9098ad924 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0093-3016 | Tadalafil | Tadalafil |
| 0093-3017 | Tadalafil | Tadalafil |
| 0093-3018 | Tadalafil | Tadalafil |
| 0093-3019 | Tadalafil | Tadalafil |
| 68180-914 | Tadalafil | Tadalafil |
| 68382-896 | Tadalafil | Tadalafil |
| 68382-898 | Tadalafil | Tadalafil |
| 68382-897 | Tadalafil | Tadalafil |
| 68382-899 | Tadalafil | Tadalafil |
| 69097-376 | Tadalafil | Tadalafil |
| 69097-375 | Tadalafil | Tadalafil |
| 69097-373 | Tadalafil | Tadalafil |
| 69097-526 | Tadalafil | Tadalafil |
| 69097-374 | Tadalafil | Tadalafil |
| 69238-1347 | Tadalafil | Tadalafil |
| 69238-1346 | Tadalafil | Tadalafil |
| 69238-1348 | Tadalafil | Tadalafil |
| 69238-1349 | Tadalafil | Tadalafil |
| 70771-1476 | Tadalafil | Tadalafil |
| 70771-1477 | Tadalafil | Tadalafil |
| 70771-1478 | Tadalafil | Tadalafil |
| 70771-1475 | Tadalafil | Tadalafil |
| 71610-214 | Tadalafil | Tadalafil |
| 71610-213 | Tadalafil | Tadalafil |
| 13668-568 | TADALAFIL | TADALAFIL |
| 13668-566 | TADALAFIL | TADALAFIL |
| 13668-567 | TADALAFIL | TADALAFIL |
| 13668-565 | TADALAFIL | TADALAFIL |
| 13668-581 | TADALAFIL | TADALAFIL |
| 16729-370 | Tadalafil | Tadalafil |
| 16729-372 | Tadalafil | Tadalafil |
| 16729-369 | Tadalafil | Tadalafil |
| 27241-123 | Tadalafil | Tadalafil |
| 27241-111 | Tadalafil | Tadalafil |
| 27241-112 | Tadalafil | Tadalafil |
| 29300-289 | tadalafil | tadalafil |
| 29300-288 | tadalafil | tadalafil |
| 27241-114 | Tadalafil | Tadalafil |
| 27241-113 | Tadalafil | Tadalafil |
| 31722-646 | Tadalafil | Tadalafil |
| 29300-286 | tadalafil | tadalafil |
| 31722-645 | Tadalafil | Tadalafil |
| 29300-287 | tadalafil | tadalafil |
| 31722-643 | Tadalafil | Tadalafil |
| 31722-647 | Tadalafil | Tadalafil |
| 31722-644 | Tadalafil | Tadalafil |
| 35573-411 | Tadalafil | Tadalafil |
| 35573-410 | Tadalafil | Tadalafil |
| 35573-412 | Tadalafil | Tadalafil |
| 35573-409 | Tadalafil | Tadalafil |