NDC 0378-1078

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 Mylan Pharmaceuticals Inc.. The primary component is Telmisartan; Amlodipine Besylate.

Product ID0378-1078_71ff682d-8dfd-496b-a983-035d60b186be
NDC0378-1078
Product TypeHuman Prescription Drug
Proprietary NameTelmisartan and Amlodipine
Generic NameTelmisartan And Amlodipine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2014-09-19
Marketing CategoryANDA / ANDA
Application NumberANDA202516
Labeler NameMylan Pharmaceuticals 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 0378-1078-93

30 TABLET in 1 BOTTLE, PLASTIC (0378-1078-93)
Marketing Start Date2014-09-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-1078-05 [00378107805]

Telmisartan and Amlodipine TABLET
Marketing CategoryANDA
Application NumberANDA202516
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-09-19
Marketing End Date2015-02-04

NDC 0378-1078-77 [00378107877]

Telmisartan and Amlodipine TABLET
Marketing CategoryANDA
Application NumberANDA202516
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-09-19
Marketing End Date2015-02-04

NDC 0378-1078-93 [00378107893]

Telmisartan and Amlodipine TABLET
Marketing CategoryANDA
Application NumberANDA202516
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-09-19

Drug Details

Active Ingredients

IngredientStrength
TELMISARTAN80 mg/1

OpenFDA Data

SPL SET ID:ca60a4d5-ace7-4889-94ee-e2265fd63811
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 876519
  • 876524
  • 876514
  • 876529
  • UPC Code
  • 0303781076937
  • 0303781075930
  • 0303781077934
  • 0303781078931
  • 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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