amlodipine besylate

Generic: amlodipine besylate

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amlodipine besylate
Generic Name amlodipine besylate
Labeler bryant ranch prepack
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amlodipine besylate 5 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-1278
Product ID 71335-1278_19f9229f-2ed5-4d1a-a854-2fe6a1b10cee
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078925
Listing Expiration 2026-12-31
Marketing Start 2010-10-20

Pharmacologic Class

Classes
calcium channel antagonists [moa] calcium channel blocker [epc] cytochrome p450 3a inhibitors [moa] dihydropyridine calcium channel blocker [epc] dihydropyridines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 713351278
Hyphenated Format 71335-1278

Supplemental Identifiers

RxCUI
197361 308135
UNII
864V2Q084H

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name amlodipine besylate (source: ndc)
Generic Name amlodipine besylate (source: ndc)
Application Number ANDA078925 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 5 TABLET in 1 BOTTLE (71335-1278-0)
  • 30 TABLET in 1 BOTTLE (71335-1278-1)
  • 90 TABLET in 1 BOTTLE (71335-1278-2)
  • 60 TABLET in 1 BOTTLE (71335-1278-3)
  • 100 TABLET in 1 BOTTLE (71335-1278-4)
  • 180 TABLET in 1 BOTTLE (71335-1278-5)
  • 120 TABLET in 1 BOTTLE (71335-1278-6)
  • 10 TABLET in 1 BOTTLE (71335-1278-7)
  • 500 TABLET in 1 BOTTLE (71335-1278-8)
  • 1000 TABLET in 1 BOTTLE (71335-1278-9)
source: ndc

Packages (10)

71335-1278-0 5 TABLET in 1 BOTTLE (71335-1278-0) 71335-1278-1 30 TABLET in 1 BOTTLE (71335-1278-1) 71335-1278-2 90 TABLET in 1 BOTTLE (71335-1278-2) 71335-1278-3 60 TABLET in 1 BOTTLE (71335-1278-3) 71335-1278-4 100 TABLET in 1 BOTTLE (71335-1278-4) 71335-1278-5 180 TABLET in 1 BOTTLE (71335-1278-5) 71335-1278-6 120 TABLET in 1 BOTTLE (71335-1278-6) 71335-1278-7 10 TABLET in 1 BOTTLE (71335-1278-7) 71335-1278-8 500 TABLET in 1 BOTTLE (71335-1278-8) 71335-1278-9 1000 TABLET in 1 BOTTLE (71335-1278-9)

Ingredients (1)

amlodipine besylate (5 mg/1)

Linked Drug Pages (1)

Amlodipine Besylate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "19f9229f-2ed5-4d1a-a854-2fe6a1b10cee", "openfda": {"unii": ["864V2Q084H"], "rxcui": ["197361", "308135"], "spl_set_id": ["1b449c22-0181-4a50-94b3-26139b90b978"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "5 TABLET in 1 BOTTLE (71335-1278-0)", "package_ndc": "71335-1278-0", "marketing_start_date": "20150723"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (71335-1278-1)", "package_ndc": "71335-1278-1", "marketing_start_date": "20150723"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71335-1278-2)", "package_ndc": "71335-1278-2", "marketing_start_date": "20150723"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71335-1278-3)", "package_ndc": "71335-1278-3", "marketing_start_date": "20150723"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (71335-1278-4)", "package_ndc": "71335-1278-4", "marketing_start_date": "20150723"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (71335-1278-5)", "package_ndc": "71335-1278-5", "marketing_start_date": "20150723"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (71335-1278-6)", "package_ndc": "71335-1278-6", "marketing_start_date": "20150723"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE (71335-1278-7)", "package_ndc": "71335-1278-7", "marketing_start_date": "20150723"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (71335-1278-8)", "package_ndc": "71335-1278-8", "marketing_start_date": "20150723"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (71335-1278-9)", "package_ndc": "71335-1278-9", "marketing_start_date": "20150723"}], "brand_name": "Amlodipine Besylate", "product_id": "71335-1278_19f9229f-2ed5-4d1a-a854-2fe6a1b10cee", "dosage_form": "TABLET", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A Inhibitors [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]"], "product_ndc": "71335-1278", "generic_name": "Amlodipine besylate", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amlodipine Besylate", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "5 mg/1"}], "application_number": "ANDA078925", "marketing_category": "ANDA", "marketing_start_date": "20101020", "listing_expiration_date": "20261231"}