NDC 71335-0218

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 ID71335-0218_0d5f2eee-73f9-43be-bb2f-19dffe292958
NDC71335-0218
Product TypeHuman Prescription Drug
Proprietary NameAMLODIPINE BESYLATE
Generic NameAmlodipine Besylate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2007-09-26
Marketing CategoryANDA / ANDA
Application NumberANDA077073
Labeler NameBryant Ranch Prepack
Substance NameAMLODIPINE BESYLATE
Active Ingredient Strength10 mg/1
Pharm ClassesCalcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 71335-0218-1

30 TABLET in 1 BOTTLE (71335-0218-1)
Marketing Start Date2018-03-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-0218-1 [71335021801]

AMLODIPINE BESYLATE TABLET
Marketing CategoryANDA
Application NumberANDA077073
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-05-31

NDC 71335-0218-6 [71335021806]

AMLODIPINE BESYLATE TABLET
Marketing CategoryANDA
Application NumberANDA077073
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-31

NDC 71335-0218-3 [71335021803]

AMLODIPINE BESYLATE TABLET
Marketing CategoryANDA
Application NumberANDA077073
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-05-31

NDC 71335-0218-2 [71335021802]

AMLODIPINE BESYLATE TABLET
Marketing CategoryANDA
Application NumberANDA077073
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-05-31

NDC 71335-0218-5 [71335021805]

AMLODIPINE BESYLATE TABLET
Marketing CategoryANDA
Application NumberANDA077073
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-05-31

NDC 71335-0218-7 [71335021807]

AMLODIPINE BESYLATE TABLET
Marketing CategoryANDA
Application NumberANDA077073
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-31

NDC 71335-0218-4 [71335021804]

AMLODIPINE BESYLATE TABLET
Marketing CategoryANDA
Application NumberANDA077073
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-05-31

Drug Details

Active Ingredients

IngredientStrength
AMLODIPINE BESYLATE10 mg/1

OpenFDA Data

SPL SET ID:215e0890-0484-45e8-a731-aea53821ad8e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 308136
  • 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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