NDC 46708-187

Telmisartan and Amlodipine

Telmisartan And Amlodipine

Telmisartan and Amlodipine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Alembic Pharmaceuticals Limited. The primary component is Telmisartan; Amlodipine Besylate.

• Product ID: 46708-187_15b438b4-4874-43f4-a50a-4e6f3e5530ac
• NDC: 46708-187
• 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: 2016-11-22
• Marketing Category: ANDA / ANDA
• Application Number: ANDA205234
• Labeler Name: Alembic Pharmaceuticals Limited
• 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: 2019-12-31

Packaging

NDC 46708-187-06

60 BLISTER PACK in 1 CARTON (46708-187-06) > 6 TABLET in 1 BLISTER PACK

• Marketing Start Date: 2016-11-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 46708-187-06 [46708018706]

Telmisartan and Amlodipine TABLET

• Marketing Category: ANDA
• Application Number: ANDA205234
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-11-22

Drug Details

Active Ingredients

Ingredient	Strength
TELMISARTAN	80 mg/1

OpenFDA Data

• SPL SET ID: 15b438b4-4874-43f4-a50a-4e6f3e5530ac
• Manufacturer:
  • Alembic Pharmaceuticals Limited
• UNII:
  • U5SYW473RQ
  • 864V2Q084H
• RxNorm Concept Unique ID - RxCUI:
  • 876519
  • 876524
  • 876514
  • 876529
• UPC Code:
  • 0346708184087
  • 0346708186067
  • 0346708187064
  • 0346708185084

Pharmacological Class

• Angiotensin 2 Receptor Antagonists [MoA]
• Angiotensin 2 Receptor Blocker [EPC]
• Calcium Channel Antagonists [MoA]
• Dihydropyridine Calcium Channel Blocker [EPC]
• Dihydropyridines [CS]

NDC Crossover Matching brand name "Telmisartan and Amlodipine" or generic name "Telmisartan And Amlodipine"

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