amlodipine besylate

Generic: amlodipine besylate

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

amlodipine besylate 5 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-520
Product ID 72189-520_1ac60230-47d7-d920-e063-6294a90a4929
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203245
Listing Expiration 2026-12-31
Marketing Start 2023-11-03

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 72189520
Hyphenated Format 72189-520

Supplemental Identifiers

RxCUI
197361
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 ANDA203245 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (72189-520-30)
  • 90 TABLET in 1 BOTTLE (72189-520-90)
source: ndc

Packages (2)

72189-520-30 30 TABLET in 1 BOTTLE (72189-520-30) 72189-520-90 90 TABLET in 1 BOTTLE (72189-520-90)

Ingredients (1)

amlodipine besylate (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": "1ac60230-47d7-d920-e063-6294a90a4929", "openfda": {"unii": ["864V2Q084H"], "rxcui": ["197361"], "spl_set_id": ["094498f2-11d9-2a05-e063-6294a90ab2e1"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (72189-520-30)", "package_ndc": "72189-520-30", "marketing_start_date": "20231103"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (72189-520-90)", "package_ndc": "72189-520-90", "marketing_start_date": "20231103"}], "brand_name": "Amlodipine Besylate", "product_id": "72189-520_1ac60230-47d7-d920-e063-6294a90a4929", "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": "72189-520", "generic_name": "Amlodipine Besylate", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amlodipine Besylate", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "5 mg/1"}], "application_number": "ANDA203245", "marketing_category": "ANDA", "marketing_start_date": "20231103", "listing_expiration_date": "20261231"}