Package 71610-978-53

Brand: amlodipine besylate 10 mg

Generic: amlodipine besylate
NDC Package

Package Facts

Identity

Package NDC 71610-978-53
Digits Only 7161097853
Product NDC 71610-978
Description

60 TABLET in 1 BOTTLE (71610-978-53)

Marketing

Marketing Status
Marketed Since 2026-01-08
Brand amlodipine besylate 10 mg
Generic amlodipine besylate
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "47e48dff-09df-2ea2-e063-6394a90a8e41", "openfda": {"unii": ["864V2Q084H"], "rxcui": ["308135"], "spl_set_id": ["47e494d2-8971-3f8f-e063-6394a90adb20"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (71610-978-30)", "package_ndc": "71610-978-30", "marketing_start_date": "20260108"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE (71610-978-45)", "package_ndc": "71610-978-45", "marketing_start_date": "20260108"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71610-978-53)", "package_ndc": "71610-978-53", "marketing_start_date": "20260108"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-978-60)", "package_ndc": "71610-978-60", "marketing_start_date": "20260108"}], "brand_name": "AMLODIPINE BESYLATE 10 mg", "product_id": "71610-978_47e48dff-09df-2ea2-e063-6394a90a8e41", "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": "71610-978", "generic_name": "AMLODIPINE BESYLATE", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AMLODIPINE BESYLATE", "brand_name_suffix": "10 mg", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "10 mg/1"}], "application_number": "ANDA078414", "marketing_category": "ANDA", "marketing_start_date": "20211001", "listing_expiration_date": "20271231"}