amlodipine besylate

Generic: amlodipine besylate

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amlodipine besylate
Generic Name amlodipine besylate
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amlodipine besylate 10 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-928
Product ID 71610-928_4910735f-515a-6896-e063-6294a90a3e7c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076719
Listing Expiration 2027-12-31
Marketing Start 2007-05-23

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 71610928
Hyphenated Format 71610-928

Supplemental Identifiers

RxCUI
308135
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 ANDA076719 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (71610-928-30)
  • 45 TABLET in 1 BOTTLE (71610-928-45)
  • 60 TABLET in 1 BOTTLE (71610-928-53)
  • 90 TABLET in 1 BOTTLE (71610-928-60)
source: ndc

Packages (4)

71610-928-30 30 TABLET in 1 BOTTLE (71610-928-30) 71610-928-45 45 TABLET in 1 BOTTLE (71610-928-45) 71610-928-53 60 TABLET in 1 BOTTLE (71610-928-53) 71610-928-60 90 TABLET in 1 BOTTLE (71610-928-60)

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": "4910735f-515a-6896-e063-6294a90a3e7c", "openfda": {"unii": ["864V2Q084H"], "rxcui": ["308135"], "spl_set_id": ["3ab4ad3d-7795-058a-e063-6294a90abc86"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (71610-928-30)", "package_ndc": "71610-928-30", "marketing_start_date": "20250723"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE (71610-928-45)", "package_ndc": "71610-928-45", "marketing_start_date": "20250723"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71610-928-53)", "package_ndc": "71610-928-53", "marketing_start_date": "20250723"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-928-60)", "package_ndc": "71610-928-60", "marketing_start_date": "20260123"}], "brand_name": "Amlodipine Besylate", "product_id": "71610-928_4910735f-515a-6896-e063-6294a90a3e7c", "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": "71610-928", "generic_name": "Amlodipine Besylate", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amlodipine Besylate", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "10 mg/1"}], "application_number": "ANDA076719", "marketing_category": "ANDA", "marketing_start_date": "20070523", "listing_expiration_date": "20271231"}