NDC 43353-251

Amlodipine besylate

Amlodipine Besylate

Amlodipine besylate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Amlodipine Besylate.

Product ID43353-251_1b830c7d-ff8d-45b1-8f56-9206fa600e36
NDC43353-251
Product TypeHuman Prescription Drug
Proprietary NameAmlodipine besylate
Generic NameAmlodipine Besylate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2007-11-02
Marketing CategoryANDA / ANDA
Application NumberANDA077955
Labeler NameAphena Pharma Solutions - Tennessee, LLC
Substance NameAMLODIPINE BESYLATE
Active Ingredient Strength5 mg/1
Pharm ClassesCalcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 43353-251-15

15 TABLET in 1 BOTTLE (43353-251-15)
Marketing Start Date2017-02-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43353-251-45 [43353025145]

Amlodipine besylate TABLET
Marketing CategoryANDA
Application NumberANDA077955
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-11-04

NDC 43353-251-60 [43353025160]

Amlodipine besylate TABLET
Marketing CategoryANDA
Application NumberANDA077955
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-01-13

NDC 43353-251-30 [43353025130]

Amlodipine besylate TABLET
Marketing CategoryANDA
Application NumberANDA077955
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-02-16

NDC 43353-251-15 [43353025115]

Amlodipine besylate TABLET
Marketing CategoryANDA
Application NumberANDA077955
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-02-16

Drug Details

Active Ingredients

IngredientStrength
AMLODIPINE BESYLATE5 mg/1

OpenFDA Data

SPL SET ID:a1d358b5-c206-463a-a364-18551da8c4e6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197361
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Amlodipine besylate" or generic name "Amlodipine Besylate"

    NDCBrand NameGeneric Name
    0054-0100Amlodipine BesylateAmlodipine Besylate
    0054-0101Amlodipine BesylateAmlodipine Besylate
    0054-0102Amlodipine BesylateAmlodipine Besylate
    0093-0083Amlodipine BesylateAmlodipine Besylate
    0093-7167Amlodipine BesylateAmlodipine Besylate
    0093-7168Amlodipine BesylateAmlodipine Besylate
    0143-9959Amlodipine besylateAmlodipine besylate
    0143-9960Amlodipine besylateAmlodipine besylate
    0143-9961Amlodipine besylateAmlodipine besylate
    0179-0210Amlodipine BesylateAmlodipine Besylate
    0179-0211Amlodipine BesylateAmlodipine Besylate
    0179-0213Amlodipine BesylateAmlodipine Besylate
    0378-5208Amlodipine Besylateamlodipine besylate
    0378-5209Amlodipine Besylateamlodipine besylate
    0378-5210Amlodipine Besylateamlodipine besylate
    0480-0083Amlodipine BesylateAmlodipine Besylate
    0480-7167Amlodipine BesylateAmlodipine Besylate
    0480-7168Amlodipine BesylateAmlodipine Besylate
    0603-2108Amlodipine Besylateamlodipine besylate
    0603-2109Amlodipine Besylateamlodipine besylate
    0603-2110Amlodipine Besylateamlodipine besylate
    0615-6577Amlodipine Besylateamlodipine besylate
    0615-6578Amlodipine Besylateamlodipine besylate
    0615-6582Amlodipine BesylateAmlodipine
    0615-7939Amlodipine BesylateAmlodipine Besylate
    0615-7941AMLODIPINE BESYLATEAMLODIPINE BESYLATE
    0615-7942Amlodipine BesylateAmlodipine Besylate
    0615-8199Amlodipine BesylateAmlodipine Besylate
    0615-8200Amlodipine BesylateAmlodipine Besylate
    0615-8201Amlodipine BesylateAmlodipine Besylate
    0615-8282AMLODIPINE BESYLATEAMLODIPINE BESYLATE
    67544-979Amlodipine BesylateAmlodipine Besylate
    67544-993Amlodipine BesylateAmlodipine Besylate
    67877-198Amlodipine BesylateAmlodipine Besylate
    67877-197Amlodipine BesylateAmlodipine Besylate
    67877-199Amlodipine BesylateAmlodipine Besylate
    68071-1902Amlodipine BesylateAmlodipine Besylate
    68071-1974AMLODIPINE BESYLATEAMLODIPINE BESYLATE
    68071-1924Amlodipine BesylateAmlodipine Besylate
    68071-1903Amlodipine BesylateAmlodipine Besylate
    68071-3188AMLODIPINE BESYLATEAMLODIPINE BESYLATE
    68071-1980AMLODIPINE BESYLATEAMLODIPINE BESYLATE
    68071-4251Amlodipine BesylateAmlodipine Besylate
    68071-3327AMLODIPINE BESYLATEAMLODIPINE BESYLATE
    68071-4776Amlodipine BesylateAmlodipine Besylate
    68151-0995Amlodipine BesylateAmlodipine Besylate
    68180-720Amlodipine BesylateAmlodipine Besylate
    68180-750Amlodipine BesylateAmlodipine Besylate
    68180-721Amlodipine BesylateAmlodipine Besylate
    68180-752Amlodipine BesylateAmlodipine Besylate

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