amlodipine besylate

Generic: amlodipine besylate

Labeler: exelan pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amlodipine besylate
Generic Name amlodipine besylate
Labeler exelan pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amlodipine besylate 10 mg/1

Manufacturer
Exelan Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 76282-509
Product ID 76282-509_17a72ab9-cae7-43c3-9913-fff5e038970b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206367
Listing Expiration 2026-12-31
Marketing Start 2022-03-15

Pharmacologic Class

Classes
calcium channel antagonists [moa] dihydropyridine calcium channel blocker [epc] dihydropyridines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76282509
Hyphenated Format 76282-509

Supplemental Identifiers

RxCUI
197361 308135 308136
UPC
0376282509051 0376282507057 0376282509907 0376282509105 0376282507101 0376282508054 0376282508108 0376282508900 0376282507903
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 (source: ndc)
Generic Name amlodipine besylate (source: ndc)
Application Number ANDA206367 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (76282-509-05)
  • 1000 TABLET in 1 BOTTLE (76282-509-10)
  • 90 TABLET in 1 BOTTLE (76282-509-90)
source: ndc

Packages (3)

76282-509-05 500 TABLET in 1 BOTTLE (76282-509-05) 76282-509-10 1000 TABLET in 1 BOTTLE (76282-509-10) 76282-509-90 90 TABLET in 1 BOTTLE (76282-509-90)

Ingredients (1)

amlodipine besylate (10 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": "17a72ab9-cae7-43c3-9913-fff5e038970b", "openfda": {"upc": ["0376282509051", "0376282507057", "0376282509907", "0376282509105", "0376282507101", "0376282508054", "0376282508108", "0376282508900", "0376282507903"], "unii": ["864V2Q084H"], "rxcui": ["197361", "308135", "308136"], "spl_set_id": ["1a24433f-4464-4c6d-9456-ed1ce38e8ec4"], "manufacturer_name": ["Exelan Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (76282-509-05)", "package_ndc": "76282-509-05", "marketing_start_date": "20220315"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (76282-509-10)", "package_ndc": "76282-509-10", "marketing_start_date": "20220315"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (76282-509-90)", "package_ndc": "76282-509-90", "marketing_start_date": "20220315"}], "brand_name": "Amlodipine besylate", "product_id": "76282-509_17a72ab9-cae7-43c3-9913-fff5e038970b", "dosage_form": "TABLET", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]"], "product_ndc": "76282-509", "generic_name": "Amlodipine besylate", "labeler_name": "Exelan Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amlodipine besylate", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "10 mg/1"}], "application_number": "ANDA206367", "marketing_category": "ANDA", "marketing_start_date": "20220315", "listing_expiration_date": "20261231"}