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 71610-938
Product ID 71610-938_3ce694ab-5a5d-7885-e063-6394a90a0a73
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076846
Listing Expiration 2026-12-31
Marketing Start 2023-06-22

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 71610938
Hyphenated Format 71610-938

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 ANDA076846 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (71610-938-30)
  • 45 TABLET in 1 BOTTLE (71610-938-45)
  • 60 TABLET in 1 BOTTLE (71610-938-53)
  • 90 TABLET in 1 BOTTLE (71610-938-60)
source: ndc

Packages (4)

71610-938-30 30 TABLET in 1 BOTTLE (71610-938-30) 71610-938-45 45 TABLET in 1 BOTTLE (71610-938-45) 71610-938-53 60 TABLET in 1 BOTTLE (71610-938-53) 71610-938-60 90 TABLET in 1 BOTTLE (71610-938-60)

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": "3ce694ab-5a5d-7885-e063-6394a90a0a73", "openfda": {"unii": ["864V2Q084H"], "rxcui": ["308135"], "spl_set_id": ["3ce6978a-6ab3-33a9-e063-6294a90a24a1"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (71610-938-30)", "package_ndc": "71610-938-30", "marketing_start_date": "20250821"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE (71610-938-45)", "package_ndc": "71610-938-45", "marketing_start_date": "20250821"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71610-938-53)", "package_ndc": "71610-938-53", "marketing_start_date": "20250821"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-938-60)", "package_ndc": "71610-938-60", "marketing_start_date": "20250821"}], "brand_name": "Amlodipine Besylate", "product_id": "71610-938_3ce694ab-5a5d-7885-e063-6394a90a0a73", "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": "71610-938", "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": "ANDA076846", "marketing_category": "ANDA", "marketing_start_date": "20230622", "listing_expiration_date": "20261231"}