amlodipine besylate 5 mg

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 5 mg
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 71610-985
Product ID 71610-985_49104c85-4322-3bb3-e063-6394a90a350e
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 71610985
Hyphenated Format 71610-985

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 5 mg (source: ndc)
Generic Name amlodipine besylate (source: ndc)
Application Number ANDA078414 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (71610-985-60)
source: ndc

Packages (1)

71610-985-60 90 TABLET in 1 BOTTLE (71610-985-60)

Ingredients (1)

amlodipine besylate (5 mg/1)

Linked Drug Pages (1)

AMLODIPINE BESYLATE 5 mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "49104c85-4322-3bb3-e063-6394a90a350e", "openfda": {"unii": ["864V2Q084H"], "rxcui": ["197361"], "spl_set_id": ["49104797-8202-1376-e063-6294a90adb38"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-985-60)", "package_ndc": "71610-985-60", "marketing_start_date": "20260122"}], "brand_name": "AMLODIPINE BESYLATE 5 mg", "product_id": "71610-985_49104c85-4322-3bb3-e063-6394a90a350e", "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": "71610-985", "generic_name": "AMLODIPINE BESYLATE", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AMLODIPINE BESYLATE", "brand_name_suffix": "5 mg", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "5 mg/1"}], "application_number": "ANDA078414", "marketing_category": "ANDA", "marketing_start_date": "20211001", "listing_expiration_date": "20271231"}