NDC 43353-044
Cialis
Tadalafil
Cialis is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Tadalafil.
| Product ID | 43353-044_6962a85a-e95c-481f-bfd0-eba3742d4101 |
| NDC | 43353-044 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Cialis |
| Generic Name | Tadalafil |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2003-11-26 |
| Marketing Category | NDA / NDA |
| Application Number | NDA021368 |
| Labeler Name | Aphena Pharma Solutions - Tennessee, LLC |
| Substance Name | TADALAFIL |
| Active Ingredient Strength | 5 mg/1 |
| Pharm Classes | Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 43353-044-04
4 TABLET, FILM COATED in 1 BOTTLE (43353-044-04)
| Marketing Start Date | 2015-05-20 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 43353-044-11 [43353004411]
Cialis TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA021368 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-01-03 |
NDC 43353-044-08 [43353004408]
Cialis TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA021368 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2015-05-20 |
NDC 43353-044-47 [43353004447]
Cialis TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA021368 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-01-03 |
NDC 43353-044-18 [43353004418]
Cialis TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA021368 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2015-05-19 |
NDC 43353-044-04 [43353004404]
Cialis TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA021368 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2015-05-20 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| TADALAFIL | 5 mg/1 |
OpenFDA Data
| SPL SET ID: | 6a6aa912-9a5d-4614-a2ce-53afb212aa12 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Phosphodiesterase 5 Inhibitor [EPC]
- Phosphodiesterase 5 Inhibitors [MoA]
NDC Crossover Matching brand name "Cialis" or generic name "Tadalafil"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0002-4462 | Cialis | Tadalafil |
| 0002-4463 | Cialis | Tadalafil |
| 0002-4464 | Cialis | Tadalafil |
| 0002-4465 | Cialis | Tadalafil |
| 21695-028 | Cialis | Cialis |
| 21695-029 | Cialis | Cialis |
| 43353-857 | Cialis | Cialis |
| 43063-236 | Cialis | Cialis |
| 43353-044 | Cialis | Cialis |
| 50436-4464 | Cialis | Cialis |
| 50436-4465 | Cialis | Cialis |
| 50436-4463 | Cialis | Cialis |
| 50436-4462 | Cialis | Cialis |
| 55154-1830 | Cialis | Cialis |
| 55154-1832 | Cialis | Cialis |
| 63629-4601 | Cialis | Cialis |
| 63629-6367 | Cialis | Cialis |
| 63629-7145 | Cialis | Cialis |
| 63629-6769 | Cialis | Cialis |
| 66336-566 | Cialis | Cialis |
| 0093-3334 | ALYQ | Tadalafil |
| 0093-3016 | Tadalafil | Tadalafil |
| 0093-3017 | Tadalafil | Tadalafil |
| 0093-3018 | Tadalafil | Tadalafil |
| 0093-3019 | Tadalafil | Tadalafil |
Trademark Results [Cialis]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CIALIS 78971555 not registered Dead/Abandoned |
ELI LILLY AND COMPANY 2006-09-11 |
 CIALIS 76536972 not registered Dead/Abandoned |
Y.Z.Y. Inc 2003-08-01 |
 CIALIS 75731188 2724589 Live/Registered |
ELI LILLY AND COMPANY 1999-06-17 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.