amlodipine besylate

Generic: amlodipine besylate

Labeler: cardinal health 107, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amlodipine besylate
Generic Name amlodipine besylate
Labeler cardinal health 107, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amlodipine besylate 2.5 mg/1

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-8093
Product ID 55154-8093_da6d6dd4-5c23-4852-9e77-ee0553de4044
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078226
Listing Expiration 2026-12-31
Marketing Start 2013-01-20

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 551548093
Hyphenated Format 55154-8093

Supplemental Identifiers

RxCUI
197361 308135 308136
UPC
0055154689205 0055154687508
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 ANDA078226 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 BAG (55154-8093-0) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

Ingredients (1)

amlodipine besylate (2.5 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "da6d6dd4-5c23-4852-9e77-ee0553de4044", "openfda": {"upc": ["0055154689205", "0055154687508"], "unii": ["864V2Q084H"], "rxcui": ["197361", "308135", "308136"], "spl_set_id": ["a74239bf-4684-424c-ba4e-6087e363265b"], "manufacturer_name": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 BAG (55154-8093-0)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "55154-8093-0", "marketing_start_date": "20130120"}], "brand_name": "Amlodipine Besylate", "product_id": "55154-8093_da6d6dd4-5c23-4852-9e77-ee0553de4044", "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": "55154-8093", "generic_name": "Amlodipine Besylate", "labeler_name": "Cardinal Health 107, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amlodipine Besylate", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "2.5 mg/1"}], "application_number": "ANDA078226", "marketing_category": "ANDA", "marketing_start_date": "20130120", "listing_expiration_date": "20261231"}