amlodipine besylate

Generic: amlodipine besylate

Labeler: polygen pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

amlodipine besylate 2.5 mg/1

Manufacturer
POLYGEN PHARMACEUTICALS INC.

Identifiers & Regulatory

Product NDC 52605-041
Product ID 52605-041_83e3e459-c254-45e3-a5ac-2e717e08c348
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207821
Listing Expiration 2026-12-31
Marketing Start 2016-07-11

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 52605041
Hyphenated Format 52605-041

Supplemental Identifiers

RxCUI
197361 308135 308136
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 ANDA207821 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (52605-041-10)
  • 90 TABLET in 1 BOTTLE (52605-041-19)
source: ndc

Packages (2)

52605-041-10 1000 TABLET in 1 BOTTLE (52605-041-10) 52605-041-19 90 TABLET in 1 BOTTLE (52605-041-19)

Ingredients (1)

amlodipine besylate (2.5 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": "83e3e459-c254-45e3-a5ac-2e717e08c348", "openfda": {"unii": ["864V2Q084H"], "rxcui": ["197361", "308135", "308136"], "spl_set_id": ["f5fbfd12-a600-482d-a306-5d6c09ae4210"], "manufacturer_name": ["POLYGEN PHARMACEUTICALS INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (52605-041-10)", "package_ndc": "52605-041-10", "marketing_start_date": "20160711"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (52605-041-19)", "package_ndc": "52605-041-19", "marketing_start_date": "20160711"}], "brand_name": "amlodipine besylate", "product_id": "52605-041_83e3e459-c254-45e3-a5ac-2e717e08c348", "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": "52605-041", "generic_name": "amlodipine besylate", "labeler_name": "POLYGEN PHARMACEUTICALS INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "amlodipine besylate", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "2.5 mg/1"}], "application_number": "ANDA207821", "marketing_category": "ANDA", "marketing_start_date": "20160711", "listing_expiration_date": "20261231"}