amlodipine besylate

Generic: amlodipine besylate

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amlodipine besylate
Generic Name amlodipine besylate
Labeler a-s medication solutions
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amlodipine besylate 10 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-5354
Product ID 50090-5354_ccb87248-13c9-455b-8e8e-3f21fd381cf8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078043
Listing Expiration 2026-12-31
Marketing Start 2018-08-15

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 500905354
Hyphenated Format 50090-5354

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 ANDA078043 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (50090-5354-0)
  • 90 TABLET in 1 BOTTLE (50090-5354-1)
  • 100 TABLET in 1 BOTTLE (50090-5354-2)
source: ndc

Packages (3)

50090-5354-0 30 TABLET in 1 BOTTLE (50090-5354-0) 50090-5354-1 90 TABLET in 1 BOTTLE (50090-5354-1) 50090-5354-2 100 TABLET in 1 BOTTLE (50090-5354-2)

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": "ccb87248-13c9-455b-8e8e-3f21fd381cf8", "openfda": {"unii": ["864V2Q084H"], "rxcui": ["308135"], "spl_set_id": ["3bd019d3-b58c-44ab-9190-606a0af5e9b6"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (50090-5354-0)", "package_ndc": "50090-5354-0", "marketing_start_date": "20201111"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (50090-5354-1)", "package_ndc": "50090-5354-1", "marketing_start_date": "20201111"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (50090-5354-2)", "package_ndc": "50090-5354-2", "marketing_start_date": "20241010"}], "brand_name": "Amlodipine Besylate", "product_id": "50090-5354_ccb87248-13c9-455b-8e8e-3f21fd381cf8", "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": "50090-5354", "generic_name": "Amlodipine Besylate", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amlodipine Besylate", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "10 mg/1"}], "application_number": "ANDA078043", "marketing_category": "ANDA", "marketing_start_date": "20180815", "listing_expiration_date": "20261231"}