NDC 42582-314

AMLODIPINE BESYLATE 5 mg

Amlodipine Besylate

AMLODIPINE BESYLATE 5 mg is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Bi-coastal Pharma International Llc. The primary component is Amlodipine Besylate.

Product ID42582-314_fbea5b50-8303-4614-8dcc-40b761ea17b3
NDC42582-314
Product TypeHuman Prescription Drug
Proprietary NameAMLODIPINE BESYLATE 5 mg
Generic NameAmlodipine Besylate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-10-05
Marketing CategoryANDA / ANDA
Application NumberANDA077516
Labeler NameBi-Coastal Pharma International LLC
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 Through2020-12-31

Packaging

NDC 42582-314-09

90 TABLET in 1 BOTTLE (42582-314-09)
Marketing Start Date2016-10-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42582-314-18 [42582031418]

AMLODIPINE BESYLATE 5 mg TABLET
Marketing CategoryANDA
Application NumberANDA077516
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-10-05

NDC 42582-314-09 [42582031409]

AMLODIPINE BESYLATE 5 mg TABLET
Marketing CategoryANDA
Application NumberANDA077516
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-10-05

Drug Details

Active Ingredients

IngredientStrength
AMLODIPINE BESYLATE5 mg/1

OpenFDA Data

SPL SET ID:705d4471-b1bc-49a7-a871-9c03f886b69e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 308136
  • 308135
  • 197361
  • UPC Code
  • 0342582315098
  • 0342582314091
  • 0342582313094
  • Pharmacological Class

    • Calcium Channel Antagonists [MoA]
    • Dihydropyridine Calcium Channel Blocker [EPC]
    • Dihydropyridines [CS]
    • Calcium Channel Antagonists [MoA]
    • Dihydropyridine Calcium Channel Blocker [EPC]
    • Dihydropyridines [CS]

    NDC Crossover Matching brand name "AMLODIPINE BESYLATE 5 mg" or generic name "Amlodipine Besylate"

    NDCBrand NameGeneric Name
    42582-314AMLODIPINE BESYLATE 5 mgAMLODIPINE BESYLATE 5 mg
    62980-507AMLODIPINE BESYLATE 5 mgAMLODIPINE BESYLATE 5 mg
    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
    0615-7939Amlodipine 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
    0069-1520Norvascamlodipine besylate
    0069-1530Norvascamlodipine besylate
    0069-1540Norvascamlodipine besylate

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