amlodipine besylate

Generic: amlodipine besylate

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name amlodipine besylate
Generic Name amlodipine besylate
Labeler mylan pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amlodipine besylate 10 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 59762-2135
Product ID 59762-2135_5ff6c418-da2b-4cdc-ac7d-ba02e69df26f
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 597622135
Hyphenated Format 59762-2135

Supplemental Identifiers

RxCUI
197361 308135 308136
UPC
0359762201096 0359762224293
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 NDA019787 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (59762-2135-1)
  • 90 TABLET in 1 BOTTLE (59762-2135-9)
source: ndc

Packages (2)

59762-2135-1 1000 TABLET in 1 BOTTLE (59762-2135-1) 59762-2135-9 90 TABLET in 1 BOTTLE (59762-2135-9)

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": "5ff6c418-da2b-4cdc-ac7d-ba02e69df26f", "openfda": {"upc": ["0359762201096", "0359762224293"], "unii": ["864V2Q084H"], "rxcui": ["197361", "308135", "308136"], "spl_set_id": ["180ee374-24f2-4b9c-9d54-8815f2b1dc9b"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (59762-2135-1)", "package_ndc": "59762-2135-1", "marketing_start_date": "20191113"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (59762-2135-9)", "package_ndc": "59762-2135-9", "marketing_start_date": "20190624"}], "brand_name": "amlodipine besylate", "product_id": "59762-2135_5ff6c418-da2b-4cdc-ac7d-ba02e69df26f", "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": "59762-2135", "generic_name": "amlodipine besylate", "labeler_name": "Mylan Pharmaceuticals Inc.", "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"}