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 2.5 mg/1

Manufacturer
DIRECT RX

Identifiers & Regulatory

Product NDC 72189-162
Product ID 72189-162_2be94c25-4a48-39f0-e063-6294a90ab40c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078925
Listing Expiration 2026-12-31
Marketing Start 2021-01-12

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 72189162
Hyphenated Format 72189-162

Supplemental Identifiers

RxCUI
308136 898342
UNII
864V2Q084H N1SN99T69T

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 ANDA078925 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (72189-162-90)
source: ndc

Packages (1)

72189-162-90 90 TABLET in 1 BOTTLE (72189-162-90)

Ingredients (1)

amlodipine besylate (2.5 mg/1)

Linked Drug Pages (1)

AMLODIPINE BESYLATE, AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2be94c25-4a48-39f0-e063-6294a90ab40c", "openfda": {"unii": ["864V2Q084H", "N1SN99T69T"], "rxcui": ["308136", "898342"], "spl_set_id": ["b8b9a3cd-c4e7-dfeb-e053-2a95a90aa719"], "manufacturer_name": ["DIRECT RX"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (72189-162-90)", "package_ndc": "72189-162-90", "marketing_start_date": "20210112"}], "brand_name": "AMLODIPINE BESYLATE", "product_id": "72189-162_2be94c25-4a48-39f0-e063-6294a90ab40c", "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": "72189-162", "generic_name": "AMLODIPINE BESYLATE", "labeler_name": "DIRECT RX", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AMLODIPINE BESYLATE", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "2.5 mg/1"}], "application_number": "ANDA078925", "marketing_category": "ANDA", "marketing_start_date": "20210112", "listing_expiration_date": "20261231"}