NDC 71335-0389

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 ID71335-0389_3b92744f-99a2-4670-b6f6-ce35e7a23d11
NDC71335-0389
Product TypeHuman Prescription Drug
Proprietary NameAmlodipine Besylate
Generic NameAmlodipine Besylate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2014-03-03
Marketing CategoryANDA / ANDA
Application NumberANDA203245
Labeler NameBryant Ranch Prepack
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 Through2023-12-31

Packaging

NDC 71335-0389-0

5 TABLET in 1 BOTTLE (71335-0389-0)
Marketing Start Date2021-12-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-0389-2 [71335038902]

Amlodipine Besylate TABLET
Marketing CategoryANDA
Application NumberANDA203245
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-03-04
Marketing End Date2018-11-30

NDC 71335-0389-7 [71335038907]

Amlodipine Besylate TABLET
Marketing CategoryANDA
Application NumberANDA203245
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-03-04
Marketing End Date2018-11-30

NDC 71335-0389-1 [71335038901]

Amlodipine Besylate TABLET
Marketing CategoryANDA
Application NumberANDA203245
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-03-04
Marketing End Date2018-11-30

NDC 71335-0389-5 [71335038905]

Amlodipine Besylate TABLET
Marketing CategoryANDA
Application NumberANDA203245
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-03-04
Marketing End Date2018-11-30

NDC 71335-0389-6 [71335038906]

Amlodipine Besylate TABLET
Marketing CategoryANDA
Application NumberANDA203245
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-03-04
Marketing End Date2018-11-30

NDC 71335-0389-3 [71335038903]

Amlodipine Besylate TABLET
Marketing CategoryANDA
Application NumberANDA203245
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-03-04
Marketing End Date2018-11-30

NDC 71335-0389-0 [71335038900]

Amlodipine Besylate TABLET
Marketing CategoryANDA
Application NumberANDA203245
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-03-04
Marketing End Date2018-11-30

NDC 71335-0389-8 [71335038908]

Amlodipine Besylate TABLET
Marketing CategoryANDA
Application NumberANDA203245
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-03-04
Marketing End Date2018-11-30

NDC 71335-0389-9 [71335038909]

Amlodipine Besylate TABLET
Marketing CategoryANDA
Application NumberANDA203245
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-03-04
Marketing End Date2018-11-30

NDC 71335-0389-4 [71335038904]

Amlodipine Besylate TABLET
Marketing CategoryANDA
Application NumberANDA203245
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-03-04
Marketing End Date2018-11-30

Drug Details

Active Ingredients

IngredientStrength
AMLODIPINE BESYLATE5 mg/1

OpenFDA Data

SPL SET ID:3b92744f-99a2-4670-b6f6-ce35e7a23d11
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 308135
  • 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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