NDC 68180-197

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 Lupin Pharmaceuticals, Inc.. The primary component is Telmisartan; Amlodipine Besylate.

Product ID68180-197_db056024-a5b4-4f2a-8fe0-8ee308cf5700
NDC68180-197
Product TypeHuman Prescription Drug
Proprietary NameTelmisartan and Amlodipine
Generic NameTelmisartan And Amlodipine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2014-01-08
Marketing CategoryANDA / ANDA
Application NumberANDA201586
Labeler NameLupin Pharmaceuticals, Inc.
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 Through2020-12-31

Packaging

NDC 68180-197-06

30 TABLET in 1 BOTTLE (68180-197-06)
Marketing Start Date2014-01-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68180-197-07 [68180019707]

Telmisartan and Amlodipine TABLET
Marketing CategoryANDA
Application NumberANDA201586
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-01-08
Marketing End Date2016-02-19

NDC 68180-197-06 [68180019706]

Telmisartan and Amlodipine TABLET
Marketing CategoryANDA
Application NumberANDA201586
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-01-08

NDC 68180-197-12 [68180019712]

Telmisartan and Amlodipine TABLET
Marketing CategoryANDA
Application NumberANDA201586
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-01-08

NDC 68180-197-09 [68180019709]

Telmisartan and Amlodipine TABLET
Marketing CategoryANDA
Application NumberANDA201586
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-01-08

Drug Details

Active Ingredients

IngredientStrength
TELMISARTAN40 mg/1

OpenFDA Data

SPL SET ID:a97fefa6-99e6-4eb7-9393-ab2252a2c7d8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 876519
  • 876524
  • 876514
  • 876529
    • UPC Code
  • 0368180199069
  • 0368180196068
  • 0368180198062

    • Pharmacological Class

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

    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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