amlodipine besylate

Generic: amlodipine besylate

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC 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 71610-469
Product ID 71610-469_d8b9ec72-8206-48b8-a474-660fc685c17d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA019787
Listing Expiration 2026-12-31
Marketing Start 2019-06-24

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 71610469
Hyphenated Format 71610-469

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 NDA019787 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (71610-469-30)
  • 45 TABLET in 1 BOTTLE (71610-469-45)
  • 60 TABLET in 1 BOTTLE (71610-469-53)
  • 90 TABLET in 1 BOTTLE (71610-469-60)
source: ndc

Packages (4)

71610-469-30 30 TABLET in 1 BOTTLE (71610-469-30) 71610-469-45 45 TABLET in 1 BOTTLE (71610-469-45) 71610-469-53 60 TABLET in 1 BOTTLE (71610-469-53) 71610-469-60 90 TABLET in 1 BOTTLE (71610-469-60)

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": "d8b9ec72-8206-48b8-a474-660fc685c17d", "openfda": {"unii": ["864V2Q084H"], "rxcui": ["308135"], "spl_set_id": ["f3482709-c5c3-4bd0-8067-ad57f31bb525"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (71610-469-30)", "package_ndc": "71610-469-30", "marketing_start_date": "20200929"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE (71610-469-45)", "package_ndc": "71610-469-45", "marketing_start_date": "20200929"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71610-469-53)", "package_ndc": "71610-469-53", "marketing_start_date": "20221017"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-469-60)", "package_ndc": "71610-469-60", "marketing_start_date": "20221017"}], "brand_name": "amlodipine besylate", "product_id": "71610-469_d8b9ec72-8206-48b8-a474-660fc685c17d", "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": "71610-469", "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": "NDA019787", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20190624", "listing_expiration_date": "20261231"}