NDC 13668-346

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 Torrent Pharmaceuticals Limited. The primary component is Amlodipine Besylate; Telmisartan.

Product ID13668-346_2dc23a8e-e7ea-4a83-999b-78e68c8c8c84
NDC13668-346
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 NumberANDA202517
Labeler NameTorrent Pharmaceuticals Limited
Substance NameAMLODIPINE BESYLATE; TELMISARTAN
Active Ingredient Strength5 mg/1; mg/1
Pharm ClassesCalcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 13668-346-01

100 TABLET in 1 BOTTLE (13668-346-01)
Marketing Start Date2014-01-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 13668-346-74 [13668034674]

Telmisartan and Amlodipine TABLET
Marketing CategoryANDA
Application NumberANDA202517
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-01-08

NDC 13668-346-01 [13668034601]

Telmisartan and Amlodipine TABLET
Marketing CategoryANDA
Application NumberANDA202517
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-01-08

NDC 13668-346-30 [13668034630]

Telmisartan and Amlodipine TABLET
Marketing CategoryANDA
Application NumberANDA202517
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-01-08

Drug Details

Active Ingredients

IngredientStrength
AMLODIPINE BESYLATE5 mg/1

OpenFDA Data

SPL SET ID:b18686fa-be94-472e-8404-c69e6869ed10
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 876519
  • 876524
  • 876514
  • 876529
    • UPC Code
  • 0313668346015
  • 0313668343014
  • 0313668345018
  • 0313668344011

    • 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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