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 5 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-691
Product ID 71610-691_9417d815-3b9a-4f80-93bc-3452217d5fe9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078552
Listing Expiration 2026-12-31
Marketing Start 2011-04-25

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 71610691
Hyphenated Format 71610-691

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 ANDA078552 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 15 TABLET in 1 BOTTLE (71610-691-15)
  • 30 TABLET in 1 BOTTLE (71610-691-30)
  • 45 TABLET in 1 BOTTLE (71610-691-45)
  • 90 TABLET in 1 BOTTLE (71610-691-60)
source: ndc

Packages (4)

71610-691-15 15 TABLET in 1 BOTTLE (71610-691-15) 71610-691-30 30 TABLET in 1 BOTTLE (71610-691-30) 71610-691-45 45 TABLET in 1 BOTTLE (71610-691-45) 71610-691-60 90 TABLET in 1 BOTTLE (71610-691-60)

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": "9417d815-3b9a-4f80-93bc-3452217d5fe9", "openfda": {"unii": ["864V2Q084H"], "rxcui": ["197361"], "spl_set_id": ["186b6149-9610-4380-9bf2-941646069276"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET in 1 BOTTLE (71610-691-15)", "package_ndc": "71610-691-15", "marketing_start_date": "20230307"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (71610-691-30)", "package_ndc": "71610-691-30", "marketing_start_date": "20230307"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE (71610-691-45)", "package_ndc": "71610-691-45", "marketing_start_date": "20230307"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-691-60)", "package_ndc": "71610-691-60", "marketing_start_date": "20230504"}], "brand_name": "AMLODIPINE BESYLATE", "product_id": "71610-691_9417d815-3b9a-4f80-93bc-3452217d5fe9", "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": "71610-691", "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": "5 mg/1"}], "application_number": "ANDA078552", "marketing_category": "ANDA", "marketing_start_date": "20110425", "listing_expiration_date": "20261231"}