NDC 46708-460

Amlodipine and Valsartan

Amlodipine And Valsartan

Amlodipine and Valsartan is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Alembic Pharmaceuticals Limited. The primary component is Amlodipine Besylate; Valsartan.

Product ID46708-460_a4df1fc7-5164-44dd-a644-cac5c71702ae
NDC46708-460
Product TypeHuman Prescription Drug
Proprietary NameAmlodipine and Valsartan
Generic NameAmlodipine And Valsartan
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2016-12-01
Marketing CategoryANDA / ANDA
Application NumberANDA202713
Labeler NameAlembic Pharmaceuticals Limited
Substance NameAMLODIPINE BESYLATE; VALSARTAN
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 Through2020-12-31

Packaging

NDC 46708-460-10

100 TABLET, FILM COATED in 1 CARTON (46708-460-10)
Marketing Start Date2016-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 46708-460-90 [46708046090]

Amlodipine and Valsartan TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202713
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-01

NDC 46708-460-10 [46708046010]

Amlodipine and Valsartan TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202713
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-01

NDC 46708-460-71 [46708046071]

Amlodipine and Valsartan TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202713
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-01

NDC 46708-460-30 [46708046030]

Amlodipine and Valsartan TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202713
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-01

NDC 46708-460-31 [46708046031]

Amlodipine and Valsartan TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202713
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-01

Drug Details

Active Ingredients

IngredientStrength
AMLODIPINE BESYLATE5 mg/1

OpenFDA Data

SPL SET ID:a9c442dc-749e-4de0-bca3-1044eb78da72
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 722126
  • 722137
  • 722131
  • 722134
  • UPC Code
  • 0346708459307
  • 0346708460303
  • 0346708461300
  • 0346708458300
  • 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 "Amlodipine and Valsartan" or generic name "Amlodipine And Valsartan"

    NDCBrand NameGeneric Name
    0093-7690Amlodipine and ValsartanAmlodipine and Valsartan
    0093-7692Amlodipine and ValsartanAmlodipine and Valsartan
    0093-7693Amlodipine and ValsartanAmlodipine and Valsartan
    0378-1721AMLODIPINE AND VALSARTANAMLODIPINE AND VALSARTAN
    0378-1722AMLODIPINE AND VALSARTANAMLODIPINE AND VALSARTAN
    0378-1723AMLODIPINE AND VALSARTANAMLODIPINE AND VALSARTAN
    0378-1724AMLODIPINE AND VALSARTANAMLODIPINE AND VALSARTAN
    0781-5615AMLODIPINE AND VALSARTANamlodipine besylate and valsartan
    0781-5628AMLODIPINE AND VALSARTANamlodipine besylate and valsartan
    0781-5639AMLODIPINE AND VALSARTANamlodipine besylate and valsartan
    0781-5643AMLODIPINE AND VALSARTANamlodipine besylate and valsartan
    13668-204Amlodipine and ValsartanAmlodipine and Valsartan
    13668-205Amlodipine and ValsartanAmlodipine and Valsartan
    13668-206Amlodipine and ValsartanAmlodipine and Valsartan
    13668-207Amlodipine and ValsartanAmlodipine and Valsartan
    40032-080Amlodipine and ValsartanAmlodipine and Valsartan
    40032-081Amlodipine and ValsartanAmlodipine and Valsartan
    40032-082Amlodipine and ValsartanAmlodipine and Valsartan
    40032-083AMLODIPINE and VALSARTANAMLODIPINE and VALSARTAN
    42291-020Amlodipine and Valsartanamlodipine and valsartan
    42291-021Amlodipine and Valsartanamlodipine and valsartan
    42291-022Amlodipine and Valsartanamlodipine and valsartan
    42291-023Amlodipine and Valsartanamlodipine and valsartan
    43386-080Amlodipine and ValsartanAmlodipine and Valsartan
    43386-081Amlodipine and ValsartanAmlodipine and Valsartan
    43386-082Amlodipine and ValsartanAmlodipine and Valsartan
    43386-083AMLODIPINE and VALSARTANAMLODIPINE and VALSARTAN
    45865-880Amlodipine and ValsartanAmlodipine and Valsartan
    45865-882Amlodipine and ValsartanAmlodipine and Valsartan
    45865-889Amlodipine and ValsartanAmlodipine and Valsartan
    68180-765Amlodipine and ValsartanAmlodipine and Valsartan
    68180-767Amlodipine and ValsartanAmlodipine and Valsartan
    68180-764Amlodipine and ValsartanAmlodipine and Valsartan
    68180-766Amlodipine and ValsartanAmlodipine and Valsartan
    46708-460Amlodipine and ValsartanAmlodipine and Valsartan
    45865-890Amlodipine and valsartanAmlodipine and valsartan
    46708-461Amlodipine and ValsartanAmlodipine and Valsartan
    46708-458Amlodipine and ValsartanAmlodipine and Valsartan
    46708-459Amlodipine and ValsartanAmlodipine and Valsartan
    49884-574Amlodipine and ValsartanAmlodipine and Valsartan
    49884-576Amlodipine and ValsartanAmlodipine and Valsartan
    49884-575Amlodipine and ValsartanAmlodipine and Valsartan
    49884-577Amlodipine and ValsartanAmlodipine and Valsartan
    50090-2471AMLODIPINE AND VALSARTANAMLODIPINE AND VALSARTAN
    57297-766Amlodipine and ValsartanAmlodipine and Valsartan
    57297-767Amlodipine and ValsartanAmlodipine and Valsartan
    57297-765Amlodipine and ValsartanAmlodipine and Valsartan
    57297-764Amlodipine and ValsartanAmlodipine and Valsartan
    62332-206Amlodipine and ValsartanAmlodipine and Valsartan
    62332-208Amlodipine and ValsartanAmlodipine and Valsartan

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