NDC 0615-8283

AMLODIPINE BESYLATE

Amlodipine Besylate

AMLODIPINE BESYLATE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Ncs Healthcare Of Ky, Inc Dba Vangard Labs. The primary component is Amlodipine Besylate.

Product ID0615-8283_43d96397-715e-4a23-b29e-d0ecc13cb22f
NDC0615-8283
Product TypeHuman Prescription Drug
Proprietary NameAMLODIPINE BESYLATE
Generic NameAmlodipine Besylate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2011-04-15
Marketing CategoryANDA / ANDA
Application NumberANDA077516
Labeler NameNCS HealthCare of KY, Inc dba Vangard Labs
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 0615-8283-05

15 TABLET in 1 BLISTER PACK (0615-8283-05)
Marketing Start Date2019-03-19
Marketing End Date2024-04-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0615-8283-05 [00615828305]

AMLODIPINE BESYLATE TABLET
Marketing CategoryANDA
Application NumberANDA077516
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-19

NDC 0615-8283-30 [00615828330]

AMLODIPINE BESYLATE TABLET
Marketing CategoryANDA
Application NumberANDA077516
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-19

NDC 0615-8283-39 [00615828339]

AMLODIPINE BESYLATE TABLET
Marketing CategoryANDA
Application NumberANDA077516
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-19

Drug Details

Active Ingredients

IngredientStrength
AMLODIPINE BESYLATE5 mg/1

OpenFDA Data

SPL SET ID:eff16b12-9d0e-4216-8cc1-3550005a769e
Manufacturer
UNII

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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