NDC 63629-3678

Amlodipine Besylate

Amlodipine Besylate

Amlodipine Besylate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Amlodipine Besylate.

Product ID63629-3678_44fb1794-6e03-4313-b33b-72fc9619f9d0
NDC63629-3678
Product TypeHuman Prescription Drug
Proprietary NameAmlodipine Besylate
Generic NameAmlodipine Besylate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2007-05-24
Marketing CategoryANDA / ANDA
Application NumberANDA076719
Labeler NameBryant Ranch Prepack
Substance NameAMLODIPINE BESYLATE
Active Ingredient Strength3 mg/1
Pharm ClassesCalcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 63629-3678-4

60 TABLET in 1 BOTTLE (63629-3678-4)
Marketing Start Date2007-05-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-3678-2 [63629367802]

Amlodipine Besylate TABLET
Marketing CategoryANDA
Application NumberANDA076719
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-05-24
Inactivation Date2019-11-27

NDC 63629-3678-4 [63629367804]

Amlodipine Besylate TABLET
Marketing CategoryANDA
Application NumberANDA076719
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-07-24
Inactivation Date2019-11-27

NDC 63629-3678-1 [63629367801]

Amlodipine Besylate TABLET
Marketing CategoryANDA
Application NumberANDA076719
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-05-24
Inactivation Date2019-11-27

NDC 63629-3678-3 [63629367803]

Amlodipine Besylate TABLET
Marketing CategoryANDA
Application NumberANDA076719
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-05-24
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
AMLODIPINE BESYLATE2.5 mg/1

OpenFDA Data

SPL SET ID:7cafaf24-3f61-45ac-82db-025616171759
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 308136
  • 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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