amlodipine besylate 10 mg

Generic: amlodipine besylate

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

Drug Facts

Product Profile

Brand Name amlodipine besylate 10 mg
Generic Name amlodipine besylate
Labeler oxford pharmaceuticals, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amlodipine besylate 10 mg/1

Manufacturer
Oxford Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69584-023
Product ID 69584-023_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 69584023
Hyphenated Format 69584-023

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

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (69584-023-09)
  • 500 TABLET in 1 BOTTLE (69584-023-50)
  • 1000 TABLET in 1 BOTTLE (69584-023-90)
  • 3000 TABLET in 1 BOTTLE (69584-023-93)
  • 5000 TABLET in 1 BOTTLE (69584-023-95)
source: ndc

Packages (5)

69584-023-09 90 TABLET in 1 BOTTLE (69584-023-09) 69584-023-50 500 TABLET in 1 BOTTLE (69584-023-50) 69584-023-90 1000 TABLET in 1 BOTTLE (69584-023-90) 69584-023-93 3000 TABLET in 1 BOTTLE (69584-023-93) 69584-023-95 5000 TABLET in 1 BOTTLE (69584-023-95)

Ingredients (1)

amlodipine besylate (10 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 (69584-023-09)", "package_ndc": "69584-023-09", "marketing_start_date": "20211001"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (69584-023-50)", "package_ndc": "69584-023-50", "marketing_start_date": "20211001"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (69584-023-90)", "package_ndc": "69584-023-90", "marketing_start_date": "20211001"}, {"sample": false, "description": "3000 TABLET in 1 BOTTLE (69584-023-93)", "package_ndc": "69584-023-93", "marketing_start_date": "20211001"}, {"sample": false, "description": "5000 TABLET in 1 BOTTLE (69584-023-95)", "package_ndc": "69584-023-95", "marketing_start_date": "20211001"}], "brand_name": "AMLODIPINE BESYLATE 10 mg", "product_id": "69584-023_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": "69584-023", "generic_name": "AMLODIPINE BESYLATE", "labeler_name": "Oxford Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AMLODIPINE BESYLATE", "brand_name_suffix": "10 mg", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "10 mg/1"}], "application_number": "ANDA078414", "marketing_category": "ANDA", "marketing_start_date": "20211001", "listing_expiration_date": "20261231"}