amlodipine besylate

Generic: amlodipine besylate

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amlodipine besylate
Generic Name amlodipine besylate
Labeler major pharmaceuticals
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amlodipine besylate 2.5 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6369
Product ID 0904-6369_56f23c85-5abd-443b-afcc-fafd8a8c8dab
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 09046369
Hyphenated Format 0904-6369

Supplemental Identifiers

RxCUI
197361 308135 308136
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
  • 100 BLISTER PACK in 1 CARTON (0904-6369-61) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

0904-6369-61 100 BLISTER PACK in 1 CARTON (0904-6369-61) / 1 TABLET in 1 BLISTER PACK

Ingredients (1)

amlodipine besylate (2.5 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": "56f23c85-5abd-443b-afcc-fafd8a8c8dab", "openfda": {"unii": ["864V2Q084H"], "rxcui": ["197361", "308135", "308136"], "spl_set_id": ["edf9b22c-e37e-4b4e-8a64-20bb036c7d2d"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-6369-61)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "0904-6369-61", "marketing_start_date": "20130120"}], "brand_name": "Amlodipine Besylate", "product_id": "0904-6369_56f23c85-5abd-443b-afcc-fafd8a8c8dab", "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": "0904-6369", "generic_name": "Amlodipine Besylate", "labeler_name": "Major Pharmaceuticals", "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"}