NDC 0603-2109

Amlodipine Besylate

Amlodipine Besylate

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

Product ID0603-2109_b4e48976-a292-4faa-a07a-9f86269b208d
NDC0603-2109
Product TypeHuman Prescription Drug
Proprietary NameAmlodipine Besylate
Generic NameAmlodipine Besylate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2010-04-07
Marketing End Date2019-06-30
Marketing CategoryANDA / ANDA
Application NumberANDA078414
Labeler NamePar Pharmaceutical
Substance NameAMLODIPINE BESYLATE
Active Ingredient Strength5 mg/1
Pharm ClassesCalcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC Exclude FlagN

Packaging

NDC 0603-2109-28

500 TABLET in 1 BOTTLE, PLASTIC (0603-2109-28)
Marketing Start Date2010-04-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0603-2109-34 [00603210934]

Amlodipine Besylate TABLET
Marketing CategoryANDA
Application NumberANDA078414
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-04-07
Marketing End Date2018-09-30

NDC 0603-2109-02 [00603210902]

Amlodipine Besylate TABLET
Marketing CategoryANDA
Application NumberANDA078414
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-04-07
Marketing End Date2018-07-31

NDC 0603-2109-21 [00603210921]

Amlodipine Besylate TABLET
Marketing CategoryANDA
Application NumberANDA078414
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-04-07
Marketing End Date2015-06-05

NDC 0603-2109-25 [00603210925]

Amlodipine Besylate TABLET
Marketing CategoryANDA
Application NumberANDA078414
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-04-07
Marketing End Date2019-06-30

NDC 0603-2109-10 [00603210910]

Amlodipine Besylate TABLET
Marketing CategoryANDA
Application NumberANDA078414
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-04-07
Marketing End Date2015-06-05

NDC 0603-2109-32 [00603210932]

Amlodipine Besylate TABLET
Marketing CategoryANDA
Application NumberANDA078414
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-04-07
Marketing End Date2019-06-30

NDC 0603-2109-28 [00603210928]

Amlodipine Besylate TABLET
Marketing CategoryANDA
Application NumberANDA078414
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-04-07
Marketing End Date2019-06-30

Drug Details

Active Ingredients

IngredientStrength
AMLODIPINE BESYLATE5 mg/1

OpenFDA Data

SPL SET ID:b4b30c56-7403-4f69-9a8e-3d82a37e8bc5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 308136
  • 308135
  • 197361
  • UPC Code
  • 0306032109286
  • 0306032108289
  • 0306032110282
  • 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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