quetiapine fumarate

Generic: quetiapine fumarate

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

Drug Facts

Product Profile

Brand Name quetiapine fumarate
Generic Name quetiapine fumarate
Labeler a-s medication solutions
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

quetiapine fumarate 100 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-3377
Product ID 50090-3377_58a25b01-535d-4257-bb96-7133f6663879
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202674
Listing Expiration 2026-12-31
Marketing Start 2016-07-01

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500903377
Hyphenated Format 50090-3377

Supplemental Identifiers

RxCUI
312743 317174
UNII
2S3PL1B6UJ

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 quetiapine fumarate (source: ndc)
Generic Name quetiapine fumarate (source: ndc)
Application Number ANDA202674 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (50090-3377-0)
  • 90 TABLET, FILM COATED in 1 BOTTLE (50090-3377-1)
source: ndc

Packages (2)

50090-3377-0 30 TABLET, FILM COATED in 1 BOTTLE (50090-3377-0) 50090-3377-1 90 TABLET, FILM COATED in 1 BOTTLE (50090-3377-1)

Ingredients (1)

quetiapine fumarate (100 mg/1)

Linked Drug Pages (1)

Quetiapine Fumarate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "58a25b01-535d-4257-bb96-7133f6663879", "openfda": {"unii": ["2S3PL1B6UJ"], "rxcui": ["312743", "317174"], "spl_set_id": ["845159aa-1ac2-41b7-ac21-d4b03e43203b"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (50090-3377-0)", "package_ndc": "50090-3377-0", "marketing_start_date": "20180221"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (50090-3377-1)", "package_ndc": "50090-3377-1", "marketing_start_date": "20180515"}], "brand_name": "Quetiapine Fumarate", "product_id": "50090-3377_58a25b01-535d-4257-bb96-7133f6663879", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "50090-3377", "generic_name": "Quetiapine Fumarate", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine Fumarate", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "100 mg/1"}], "application_number": "ANDA202674", "marketing_category": "ANDA", "marketing_start_date": "20160701", "listing_expiration_date": "20261231"}