amlodipine besylate 5 mg

Generic: amlodipine besylate

Labeler: oxford pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amlodipine besylate 5 mg
Generic Name amlodipine besylate
Labeler oxford pharmaceuticals, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amlodipine besylate 5 mg/1

Manufacturer
Oxford Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69584-022
Product ID 69584-022_37bc3d9c-697e-4dbd-96e4-daba4873840c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078414
Listing Expiration 2026-12-31
Marketing Start 2021-10-01

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 69584022
Hyphenated Format 69584-022

Supplemental Identifiers

RxCUI
197361 308135 308136
UNII
864V2Q084H

Packaging Origin

Original Packager
true

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 5 mg (source: ndc)
Generic Name amlodipine besylate (source: ndc)
Application Number ANDA078414 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (69584-022-09)
  • 500 TABLET in 1 BOTTLE (69584-022-50)
  • 1000 TABLET in 1 AMPULE (69584-022-90)
  • 5000 TABLET in 1 BOTTLE (69584-022-95)
source: ndc

Packages (4)

69584-022-09 90 TABLET in 1 BOTTLE (69584-022-09) 69584-022-50 500 TABLET in 1 BOTTLE (69584-022-50) 69584-022-90 1000 TABLET in 1 AMPULE (69584-022-90) 69584-022-95 5000 TABLET in 1 BOTTLE (69584-022-95)

Ingredients (1)

amlodipine besylate (5 mg/1)

Linked Drug Pages (1)

AMLODIPINE BESYLATE 2.5 mg, AMLODIPINE BESYLATE 5 mg, AMLODIPINE BESYLATE 10 mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "37bc3d9c-697e-4dbd-96e4-daba4873840c", "openfda": {"unii": ["864V2Q084H"], "rxcui": ["197361", "308135", "308136"], "spl_set_id": ["6f20efca-943b-4bc2-a157-0931bd4d4585"], "manufacturer_name": ["Oxford Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (69584-022-09)", "package_ndc": "69584-022-09", "marketing_start_date": "20211001"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (69584-022-50)", "package_ndc": "69584-022-50", "marketing_start_date": "20211001"}, {"sample": false, "description": "1000 TABLET in 1 AMPULE (69584-022-90)", "package_ndc": "69584-022-90", "marketing_start_date": "20211001"}, {"sample": false, "description": "5000 TABLET in 1 BOTTLE (69584-022-95)", "package_ndc": "69584-022-95", "marketing_start_date": "20211001"}], "brand_name": "AMLODIPINE BESYLATE 5 mg", "product_id": "69584-022_37bc3d9c-697e-4dbd-96e4-daba4873840c", "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": "69584-022", "generic_name": "AMLODIPINE BESYLATE", "labeler_name": "Oxford Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AMLODIPINE BESYLATE", "brand_name_suffix": "5 mg", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "5 mg/1"}], "application_number": "ANDA078414", "marketing_category": "ANDA", "marketing_start_date": "20211001", "listing_expiration_date": "20261231"}