amlodipine besylate

Generic: amlodipine besylate

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

Drug Facts

Product Profile

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

amlodipine besylate 5 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8627
Product ID 68788-8627_1941fbe2-32c3-4374-b0e2-fce704333fc8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077073
Listing Expiration 2027-12-31
Marketing Start 2024-04-10

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 687888627
Hyphenated Format 68788-8627

Supplemental Identifiers

RxCUI
197361
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 ANDA077073 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68788-8627-1)
  • 30 TABLET in 1 BOTTLE (68788-8627-3)
  • 60 TABLET in 1 BOTTLE (68788-8627-6)
  • 90 TABLET in 1 BOTTLE (68788-8627-9)
source: ndc

Packages (4)

68788-8627-1 100 TABLET in 1 BOTTLE (68788-8627-1) 68788-8627-3 30 TABLET in 1 BOTTLE (68788-8627-3) 68788-8627-6 60 TABLET in 1 BOTTLE (68788-8627-6) 68788-8627-9 90 TABLET in 1 BOTTLE (68788-8627-9)

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": "1941fbe2-32c3-4374-b0e2-fce704333fc8", "openfda": {"unii": ["864V2Q084H"], "rxcui": ["197361"], "spl_set_id": ["aec7618e-c9da-431f-8b6a-14aa399242f6"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68788-8627-1)", "package_ndc": "68788-8627-1", "marketing_start_date": "20240410"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68788-8627-3)", "package_ndc": "68788-8627-3", "marketing_start_date": "20240410"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (68788-8627-6)", "package_ndc": "68788-8627-6", "marketing_start_date": "20240410"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68788-8627-9)", "package_ndc": "68788-8627-9", "marketing_start_date": "20240410"}], "brand_name": "AMLODIPINE BESYLATE", "product_id": "68788-8627_1941fbe2-32c3-4374-b0e2-fce704333fc8", "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": "68788-8627", "generic_name": "AMLODIPINE BESYLATE", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AMLODIPINE BESYLATE", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "5 mg/1"}], "application_number": "ANDA077073", "marketing_category": "ANDA", "marketing_start_date": "20240410", "listing_expiration_date": "20271231"}