NDC 61919-782

AMLODIPINE BESYLATE

Amlodipine Besylate

AMLODIPINE BESYLATE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Amlodipine Besylate.

Product ID61919-782_48f94245-3a9e-0b7c-e054-00144ff88e88
NDC61919-782
Product TypeHuman Prescription Drug
Proprietary NameAMLODIPINE BESYLATE
Generic NameAmlodipine Besylate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-02-20
Marketing CategoryANDA / ANDA
Application NumberANDA203245
Labeler NameDIRECT RX
Substance NameAMLODIPINE BESYLATE
Active Ingredient Strength10 mg/1
Pharm ClassesCalcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 61919-782-30

30 TABLET in 1 BOTTLE (61919-782-30)
Marketing Start Date2019-07-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-782-71 [61919078271]

AMLODIPINE BESYLATE TABLET
Marketing CategoryANDA
Application NumberANDA203245
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-21

NDC 61919-782-90 [61919078290]

AMLODIPINE BESYLATE TABLET
Marketing CategoryANDA
Application NumberANDA203245
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-02-20
Inactivation Date2020-01-31

NDC 61919-782-30 [61919078230]

AMLODIPINE BESYLATE TABLET
Marketing CategoryANDA
Application NumberANDA203245
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-07-29

Drug Details

Active Ingredients

IngredientStrength
AMLODIPINE BESYLATE10 mg/1

OpenFDA Data

SPL SET ID:4910c9c2-d290-38c4-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 308135
  • 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.