amlodipine besylate

Generic: amlodipine besylate

Labeler: quallent pharmaceuticals health llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amlodipine besylate
Generic Name amlodipine besylate
Labeler quallent pharmaceuticals health llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amlodipine besylate 10 mg/1

Manufacturer
Quallent Pharmaceuticals Health LLC

Identifiers & Regulatory

Product NDC 82009-028
Product ID 82009-028_72ad7e01-b3db-46b3-af3f-746e5ec70cd0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077073
Listing Expiration 2026-12-31
Marketing Start 2022-12-01

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 82009028
Hyphenated Format 82009-028

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 (source: ndc)
Generic Name amlodipine besylate (source: ndc)
Application Number ANDA077073 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (82009-028-10)
source: ndc

Packages (1)

82009-028-10 1000 TABLET in 1 BOTTLE (82009-028-10)

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": "72ad7e01-b3db-46b3-af3f-746e5ec70cd0", "openfda": {"unii": ["864V2Q084H"], "rxcui": ["197361", "308135", "308136"], "spl_set_id": ["c262dedb-1d13-4447-9355-f11e1dbbfb4d"], "manufacturer_name": ["Quallent Pharmaceuticals Health LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (82009-028-10)", "package_ndc": "82009-028-10", "marketing_start_date": "20221201"}], "brand_name": "AMLODIPINE BESYLATE", "product_id": "82009-028_72ad7e01-b3db-46b3-af3f-746e5ec70cd0", "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": "82009-028", "generic_name": "AMLODIPINE BESYLATE", "labeler_name": "Quallent Pharmaceuticals Health LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AMLODIPINE BESYLATE", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "10 mg/1"}], "application_number": "ANDA077073", "marketing_category": "ANDA", "marketing_start_date": "20221201", "listing_expiration_date": "20261231"}