amlodipine besylate

Generic: amlodipine besylate

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

Drug Facts

Product Profile

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

amlodipine besylate 2.5 mg/1

Manufacturer
Teva Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0480-0083
Product ID 0480-0083_2e80607e-f2c3-4966-b360-4b39d3d1dfd1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076846
Listing Expiration 2026-12-31
Marketing Start 2022-10-01

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 04800083
Hyphenated Format 0480-0083

Supplemental Identifiers

RxCUI
197361 308135 308136
UPC
0304807167981
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 ANDA076846 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (0480-0083-05)
source: ndc

Packages (1)

0480-0083-05 500 TABLET in 1 BOTTLE (0480-0083-05)

Ingredients (1)

amlodipine besylate (2.5 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": "2e80607e-f2c3-4966-b360-4b39d3d1dfd1", "openfda": {"upc": ["0304807167981"], "unii": ["864V2Q084H"], "rxcui": ["197361", "308135", "308136"], "spl_set_id": ["47edc328-2444-4ca1-a5c1-7c83141e105c"], "manufacturer_name": ["Teva Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (0480-0083-05)", "package_ndc": "0480-0083-05", "marketing_start_date": "20230511"}], "brand_name": "Amlodipine Besylate", "product_id": "0480-0083_2e80607e-f2c3-4966-b360-4b39d3d1dfd1", "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": "0480-0083", "generic_name": "Amlodipine Besylate", "labeler_name": "Teva Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amlodipine Besylate", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "2.5 mg/1"}], "application_number": "ANDA076846", "marketing_category": "ANDA", "marketing_start_date": "20221001", "listing_expiration_date": "20261231"}