NDC 62980-506

AMLODIPINE BESYLATE 2.5 mg

Amlodipine Besylate

AMLODIPINE BESYLATE 2.5 mg is a Oral; Oral; Oral; Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Vivimed Labs Limited. The primary component is Amlodipine Besylate.

Product ID62980-506_47f12917-32b3-4c67-95eb-29568f509556
NDC62980-506
Product TypeHuman Prescription Drug
Proprietary NameAMLODIPINE BESYLATE 2.5 mg
Generic NameAmlodipine Besylate
Dosage FormTablet
Route of AdministrationORAL; ORAL; ORAL; ORAL
Marketing Start Date2015-04-01
Marketing CategoryANDA / ANDA
Application NumberANDA077516
Labeler NameVivimed Labs Limited
Substance NameAMLODIPINE BESYLATE
Active Ingredient Strength3 mg/1
Pharm ClassesCalcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 62980-506-04

1000 TABLET in 1 BOTTLE (62980-506-04)
Marketing Start Date2017-08-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 62980-506-03 [62980050603]

AMLODIPINE BESYLATE 2.5 mg TABLET
Marketing CategoryANDA
Application NumberANDA077516
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-12
Marketing End Date2019-11-26

NDC 62980-506-02 [62980050602]

AMLODIPINE BESYLATE 2.5 mg TABLET
Marketing CategoryANDA
Application NumberANDA077516
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-04-01
Marketing End Date2019-11-26

NDC 62980-506-01 [62980050601]

AMLODIPINE BESYLATE 2.5 mg TABLET
Marketing CategoryANDA
Application NumberANDA077516
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-04-01
Marketing End Date2019-11-26

NDC 62980-506-04 [62980050604]

AMLODIPINE BESYLATE 2.5 mg TABLET
Marketing CategoryANDA
Application NumberANDA077516
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-12
Marketing End Date2019-11-26

Drug Details

Active Ingredients

IngredientStrength
AMLODIPINE BESYLATE2.5 mg/1

OpenFDA Data

SPL SET ID:4b0616ab-8d0a-4310-b6b1-5d22c32a4da5
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 2.5 mg" or generic name "Amlodipine Besylate"

    NDCBrand NameGeneric Name
    42582-313AMLODIPINE BESYLATE 2.5 mgAMLODIPINE BESYLATE 2.5 mg
    62980-506AMLODIPINE BESYLATE 2.5 mgAMLODIPINE BESYLATE 2.5 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

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