NDC 46708-185

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 ID46708-185_15b438b4-4874-43f4-a50a-4e6f3e5530ac
NDC46708-185
Product TypeHuman Prescription Drug
Proprietary NameTelmisartan and Amlodipine
Generic NameTelmisartan And Amlodipine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-11-22
Marketing CategoryANDA / ANDA
Application NumberANDA205234
Labeler NameAlembic Pharmaceuticals Limited
Substance NameTELMISARTAN; AMLODIPINE BESYLATE
Active Ingredient Strength40 mg/1; mg/1
Pharm ClassesAngiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 46708-185-08

80 BLISTER PACK in 1 CARTON (46708-185-08) > 8 TABLET in 1 BLISTER PACK
Marketing Start Date2016-11-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 46708-185-08 [46708018508]

Telmisartan and Amlodipine TABLET
Marketing CategoryANDA
Application NumberANDA205234
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-11-22

Drug Details

Active Ingredients

IngredientStrength
TELMISARTAN40 mg/1

OpenFDA Data

SPL SET ID:15b438b4-4874-43f4-a50a-4e6f3e5530ac
Manufacturer
UNII
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"

    NDCBrand NameGeneric Name
    0378-1075Telmisartan and Amlodipinetelmisartan and amlodipine
    0378-1076Telmisartan and Amlodipinetelmisartan and amlodipine
    0378-1077Telmisartan and Amlodipinetelmisartan and amlodipine
    0378-1078Telmisartan and Amlodipinetelmisartan and amlodipine
    13668-343Telmisartan and AmlodipineTelmisartan and Amlodipine
    13668-344Telmisartan and AmlodipineTelmisartan and Amlodipine
    13668-345Telmisartan and AmlodipineTelmisartan and Amlodipine
    13668-346Telmisartan and AmlodipineTelmisartan and Amlodipine
    42291-793Telmisartan and AmlodipineTelmisartan and Amlodipine
    42291-794Telmisartan and AmlodipineTelmisartan and Amlodipine
    42291-795Telmisartan and AmlodipineTelmisartan and Amlodipine
    42291-796Telmisartan and AmlodipineTelmisartan and Amlodipine
    46708-184Telmisartan and AmlodipineTelmisartan and Amlodipine
    46708-185Telmisartan and AmlodipineTelmisartan and Amlodipine
    46708-186Telmisartan and AmlodipineTelmisartan and Amlodipine
    46708-187Telmisartan and AmlodipineTelmisartan and Amlodipine
    68180-196Telmisartan and AmlodipineTelmisartan and Amlodipine
    68180-197Telmisartan and AmlodipineTelmisartan and Amlodipine
    68180-198Telmisartan and AmlodipineTelmisartan and Amlodipine
    68180-199Telmisartan and AmlodipineTelmisartan and Amlodipine

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