amlodipine besylate 10 mg (71610-978)

Drug Facts

Product Profile

Brand Name amlodipine besylate 10 mg

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 71610-978

Product ID 71610-978_47e48dff-09df-2ea2-e063-6394a90a8e41

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA078414

Listing Expiration 2027-12-31

Marketing Start 2021-10-01

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 71610978

Hyphenated Format 71610-978

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 10 mg (source: ndc)

Generic Name amlodipine besylate (source: ndc)

Application Number ANDA078414 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

10 mg/1

source: ndc

Packaging

30 TABLET in 1 BOTTLE (71610-978-30)
45 TABLET in 1 BOTTLE (71610-978-45)
60 TABLET in 1 BOTTLE (71610-978-53)
90 TABLET in 1 BOTTLE (71610-978-60)

source: ndc

Packages (4)

71610-978-30 30 TABLET in 1 BOTTLE (71610-978-30) 71610-978-45 45 TABLET in 1 BOTTLE (71610-978-45) 71610-978-53 60 TABLET in 1 BOTTLE (71610-978-53) 71610-978-60 90 TABLET in 1 BOTTLE (71610-978-60)

Ingredients (1)

amlodipine besylate (10 mg/1)

Linked Drug Pages (1)

AMLODIPINE BESYLATE 10 mg ndc-match (0.9)

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"}