amlodipine besylate

Generic: amlodipine besylate

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

amlodipine besylate 10 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-123
Product ID 68382-123_cd7a7360-2639-480a-af3d-0cb410c22110
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078226
Listing Expiration 2026-12-31
Marketing Start 2007-09-21

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 68382123
Hyphenated Format 68382-123

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 ANDA078226 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68382-123-01)
  • 500 TABLET in 1 BOTTLE (68382-123-05)
  • 90 TABLET in 1 BOTTLE (68382-123-16)
  • 10 BLISTER PACK in 1 CARTON (68382-123-77) / 10 TABLET in 1 BLISTER PACK
source: ndc

Packages (4)

68382-123-01 100 TABLET in 1 BOTTLE (68382-123-01) 68382-123-05 500 TABLET in 1 BOTTLE (68382-123-05) 68382-123-16 90 TABLET in 1 BOTTLE (68382-123-16) 68382-123-77 10 BLISTER PACK in 1 CARTON (68382-123-77) / 10 TABLET in 1 BLISTER PACK

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": "cd7a7360-2639-480a-af3d-0cb410c22110", "openfda": {"unii": ["864V2Q084H"], "rxcui": ["197361", "308135", "308136"], "spl_set_id": ["fda0739d-b355-478c-acae-8f773a3ec4b3"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68382-123-01)", "package_ndc": "68382-123-01", "marketing_start_date": "20070921"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (68382-123-05)", "package_ndc": "68382-123-05", "marketing_start_date": "20070921"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68382-123-16)", "package_ndc": "68382-123-16", "marketing_start_date": "20070921"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68382-123-77)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "68382-123-77", "marketing_start_date": "20070921"}], "brand_name": "Amlodipine Besylate", "product_id": "68382-123_cd7a7360-2639-480a-af3d-0cb410c22110", "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": "68382-123", "generic_name": "Amlodipine Besylate", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amlodipine Besylate", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "10 mg/1"}], "application_number": "ANDA078226", "marketing_category": "ANDA", "marketing_start_date": "20070921", "listing_expiration_date": "20261231"}