Telmisartan and Amlodipine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Telmisartan; Amlodipine Besylate.
| Product ID | 0378-1078_71ff682d-8dfd-496b-a983-035d60b186be |
| NDC | 0378-1078 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Telmisartan and Amlodipine |
| Generic Name | Telmisartan And Amlodipine |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2014-09-19 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA202516 |
| Labeler Name | Mylan Pharmaceuticals Inc. |
| Substance Name | TELMISARTAN; AMLODIPINE BESYLATE |
| Active Ingredient Strength | 80 mg/1; mg/1 |
| Pharm Classes | Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2014-09-19 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA202516 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2014-09-19 |
| Marketing End Date | 2015-02-04 |
| Marketing Category | ANDA |
| Application Number | ANDA202516 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2014-09-19 |
| Marketing End Date | 2015-02-04 |
| Marketing Category | ANDA |
| Application Number | ANDA202516 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2014-09-19 |
| Ingredient | Strength |
|---|---|
| TELMISARTAN | 80 mg/1 |
| SPL SET ID: | ca60a4d5-ace7-4889-94ee-e2265fd63811 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0378-1075 | Telmisartan and Amlodipine | telmisartan and amlodipine |
| 0378-1076 | Telmisartan and Amlodipine | telmisartan and amlodipine |
| 0378-1077 | Telmisartan and Amlodipine | telmisartan and amlodipine |
| 0378-1078 | Telmisartan and Amlodipine | telmisartan and amlodipine |
| 13668-343 | Telmisartan and Amlodipine | Telmisartan and Amlodipine |
| 13668-344 | Telmisartan and Amlodipine | Telmisartan and Amlodipine |
| 13668-345 | Telmisartan and Amlodipine | Telmisartan and Amlodipine |
| 13668-346 | Telmisartan and Amlodipine | Telmisartan and Amlodipine |
| 42291-793 | Telmisartan and Amlodipine | Telmisartan and Amlodipine |
| 42291-794 | Telmisartan and Amlodipine | Telmisartan and Amlodipine |
| 42291-795 | Telmisartan and Amlodipine | Telmisartan and Amlodipine |
| 42291-796 | Telmisartan and Amlodipine | Telmisartan and Amlodipine |
| 46708-184 | Telmisartan and Amlodipine | Telmisartan and Amlodipine |
| 46708-185 | Telmisartan and Amlodipine | Telmisartan and Amlodipine |
| 46708-186 | Telmisartan and Amlodipine | Telmisartan and Amlodipine |
| 46708-187 | Telmisartan and Amlodipine | Telmisartan and Amlodipine |
| 68180-196 | Telmisartan and Amlodipine | Telmisartan and Amlodipine |
| 68180-197 | Telmisartan and Amlodipine | Telmisartan and Amlodipine |
| 68180-198 | Telmisartan and Amlodipine | Telmisartan and Amlodipine |
| 68180-199 | Telmisartan and Amlodipine | Telmisartan and Amlodipine |