amlodipine besylate

Generic: amlodipine besylate

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

Drug Facts

Product Profile

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

amlodipine besylate 10 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-721
Product ID 68180-721_63bc4df8-5e26-45dd-8a05-78ee94553129
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078043
Listing Expiration 2026-12-31
Marketing Start 2018-08-15

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 68180721
Hyphenated Format 68180-721

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 ANDA078043 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (68180-721-03)
  • 90 TABLET in 1 BOTTLE (68180-721-09)
source: ndc

Packages (2)

68180-721-03 1000 TABLET in 1 BOTTLE (68180-721-03) 68180-721-09 90 TABLET in 1 BOTTLE (68180-721-09)

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": "63bc4df8-5e26-45dd-8a05-78ee94553129", "openfda": {"unii": ["864V2Q084H"], "rxcui": ["197361", "308135", "308136"], "spl_set_id": ["003dd1ec-16f8-4f96-b6a8-c4689d35892a"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (68180-721-03)", "package_ndc": "68180-721-03", "marketing_start_date": "20181023"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68180-721-09)", "package_ndc": "68180-721-09", "marketing_start_date": "20180815"}], "brand_name": "Amlodipine Besylate", "product_id": "68180-721_63bc4df8-5e26-45dd-8a05-78ee94553129", "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": "68180-721", "generic_name": "Amlodipine Besylate", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amlodipine Besylate", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "10 mg/1"}], "application_number": "ANDA078043", "marketing_category": "ANDA", "marketing_start_date": "20180815", "listing_expiration_date": "20261231"}