amlodipine besylate 10 mg

Generic: amlodipine besylate

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amlodipine besylate 10 mg
Generic Name amlodipine besylate
Labeler proficient rx lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amlodipine besylate 10 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-971
Product ID 82804-971_6313edc5-d2d5-44a1-a06f-7f7829c870d2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078414
Listing Expiration 2026-12-31
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 82804971
Hyphenated Format 82804-971

Supplemental Identifiers

RxCUI
197361 308135 308136
UPC
0382804969302 0382804970308 0382804971305
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
  • 100 TABLET in 1 BOTTLE (82804-971-00)
  • 1000 TABLET in 1 BOTTLE (82804-971-11)
  • 30 TABLET in 1 BOTTLE (82804-971-30)
  • 500 TABLET in 1 BOTTLE (82804-971-55)
  • 60 TABLET in 1 BOTTLE (82804-971-60)
  • 120 TABLET in 1 BOTTLE (82804-971-72)
  • 90 TABLET in 1 BOTTLE (82804-971-90)
source: ndc

Packages (7)

82804-971-00 100 TABLET in 1 BOTTLE (82804-971-00) 82804-971-11 1000 TABLET in 1 BOTTLE (82804-971-11) 82804-971-30 30 TABLET in 1 BOTTLE (82804-971-30) 82804-971-55 500 TABLET in 1 BOTTLE (82804-971-55) 82804-971-60 60 TABLET in 1 BOTTLE (82804-971-60) 82804-971-72 120 TABLET in 1 BOTTLE (82804-971-72) 82804-971-90 90 TABLET in 1 BOTTLE (82804-971-90)

Ingredients (1)

amlodipine besylate (10 mg/1)

Linked Drug Pages (1)

AMLODIPINE BESYLATE 2.5 mg, AMLODIPINE BESYLATE 5 mg, AMLODIPINE BESYLATE 10 mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6313edc5-d2d5-44a1-a06f-7f7829c870d2", "openfda": {"upc": ["0382804969302", "0382804970308", "0382804971305"], "unii": ["864V2Q084H"], "rxcui": ["197361", "308135", "308136"], "spl_set_id": ["6313edc5-d2d5-44a1-a06f-7f7829c870d2"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (82804-971-00)", "package_ndc": "82804-971-00", "marketing_start_date": "20250213"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (82804-971-11)", "package_ndc": "82804-971-11", "marketing_start_date": "20250213"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (82804-971-30)", "package_ndc": "82804-971-30", "marketing_start_date": "20250213"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (82804-971-55)", "package_ndc": "82804-971-55", "marketing_start_date": "20250213"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (82804-971-60)", "package_ndc": "82804-971-60", "marketing_start_date": "20250213"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (82804-971-72)", "package_ndc": "82804-971-72", "marketing_start_date": "20250213"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (82804-971-90)", "package_ndc": "82804-971-90", "marketing_start_date": "20250213"}], "brand_name": "AMLODIPINE BESYLATE 10 mg", "product_id": "82804-971_6313edc5-d2d5-44a1-a06f-7f7829c870d2", "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": "82804-971", "generic_name": "AMLODIPINE BESYLATE", "labeler_name": "Proficient Rx LP", "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": "20261231"}