amlodipine besylate

Generic: amlodipine besylate

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

amlodipine besylate 5 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-026
Product ID 42291-026_48481e73-92af-d506-e063-6394a90a6518
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076846
Listing Expiration 2027-12-31
Marketing Start 2023-06-22

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 42291026
Hyphenated Format 42291-026

Supplemental Identifiers

RxCUI
197361 308135 308136
UPC
0342291025103 0342291026100
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 ANDA076846 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (42291-026-10)
source: ndc

Packages (1)

42291-026-10 1000 TABLET in 1 BOTTLE (42291-026-10)

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": "48481e73-92af-d506-e063-6394a90a6518", "openfda": {"upc": ["0342291025103", "0342291026100"], "unii": ["864V2Q084H"], "rxcui": ["197361", "308135", "308136"], "spl_set_id": ["feb9438a-9cbc-4855-e053-6394a90af15e"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (42291-026-10)", "package_ndc": "42291-026-10", "marketing_start_date": "20230622"}], "brand_name": "Amlodipine Besylate", "product_id": "42291-026_48481e73-92af-d506-e063-6394a90a6518", "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": "42291-026", "generic_name": "Amlodipine Besylate", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amlodipine Besylate", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "5 mg/1"}], "application_number": "ANDA076846", "marketing_category": "ANDA", "marketing_start_date": "20230622", "listing_expiration_date": "20271231"}