amlodipine besylate

Generic: amlodipine besylate

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amlodipine besylate
Generic Name amlodipine besylate
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amlodipine besylate 10 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-103
Product ID 65862-103_7929af8c-f3da-4b86-8388-20bbe247336e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078021
Listing Expiration 2027-12-31
Marketing Start 2007-07-17

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 65862103
Hyphenated Format 65862-103

Supplemental Identifiers

RxCUI
197361 308135 308136
UPC
0365862101303 0365862103307 0365862102300
UNII
864V2Q084H

Packaging Origin

Original Packager
true

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 ANDA078021 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (65862-103-05)
  • 30 TABLET in 1 BOTTLE (65862-103-30)
  • 90 TABLET in 1 BOTTLE (65862-103-90)
  • 1000 TABLET in 1 BOTTLE (65862-103-99)
source: ndc

Packages (4)

65862-103-05 500 TABLET in 1 BOTTLE (65862-103-05) 65862-103-30 30 TABLET in 1 BOTTLE (65862-103-30) 65862-103-90 90 TABLET in 1 BOTTLE (65862-103-90) 65862-103-99 1000 TABLET in 1 BOTTLE (65862-103-99)

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": "7929af8c-f3da-4b86-8388-20bbe247336e", "openfda": {"upc": ["0365862101303", "0365862103307", "0365862102300"], "unii": ["864V2Q084H"], "rxcui": ["197361", "308135", "308136"], "spl_set_id": ["b6f298ba-2d7e-4a3c-9edb-8b60aba716d6"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (65862-103-05)", "package_ndc": "65862-103-05", "marketing_start_date": "20070717"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (65862-103-30)", "package_ndc": "65862-103-30", "marketing_start_date": "20070717"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (65862-103-90)", "package_ndc": "65862-103-90", "marketing_start_date": "20070717"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (65862-103-99)", "package_ndc": "65862-103-99", "marketing_start_date": "20070717"}], "brand_name": "Amlodipine Besylate", "product_id": "65862-103_7929af8c-f3da-4b86-8388-20bbe247336e", "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": "65862-103", "generic_name": "Amlodipine Besylate", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amlodipine Besylate", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "10 mg/1"}], "application_number": "ANDA078021", "marketing_category": "ANDA", "marketing_start_date": "20070717", "listing_expiration_date": "20271231"}