NDC 42291-795

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 Avkare, Inc.. The primary component is Telmisartan; Amlodipine Besylate.

Product ID42291-795_64049ddd-4d32-f644-e053-2a91aa0a714d
NDC42291-795
Product TypeHuman Prescription Drug
Proprietary NameTelmisartan and Amlodipine
Generic NameTelmisartan And Amlodipine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-08-09
Marketing CategoryANDA / ANDA
Application NumberANDA201586
Labeler NameAvKARE, Inc.
Substance NameTELMISARTAN; AMLODIPINE BESYLATE
Active Ingredient Strength80 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 Through2020-12-31

Packaging

NDC 42291-795-30

30 TABLET in 1 BOTTLE (42291-795-30)
Marketing Start Date2017-08-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42291-795-30 [42291079530]

Telmisartan and Amlodipine TABLET
Marketing CategoryANDA
Application NumberANDA201586
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-08-09

Drug Details

Active Ingredients

IngredientStrength
TELMISARTAN80 mg/1

OpenFDA Data

SPL SET ID:0adaf7b0-e491-4c02-a128-08cef862632a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 876519
  • 876524
  • 876514
  • 876529
  • UPC Code
  • 0342291795303
  • 0342291796300
  • Pharmacological Class

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