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 300 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-3983
Product ID 50090-3983_51994a6c-153b-4f07-b3c9-4b7d2dfee326
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202674
Listing Expiration 2027-12-31
Marketing Start 2016-07-01

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500903983
Hyphenated Format 50090-3983

Supplemental Identifiers

RxCUI
312745
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
  • 300 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3983-0)
source: ndc

Packages (1)

50090-3983-0 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3983-0)

Ingredients (1)

quetiapine fumarate (300 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": "51994a6c-153b-4f07-b3c9-4b7d2dfee326", "openfda": {"unii": ["2S3PL1B6UJ"], "rxcui": ["312745"], "spl_set_id": ["42bd7dd3-9f81-4d8b-bce9-302e5559da2f"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3983-0)", "package_ndc": "50090-3983-0", "marketing_start_date": "20181217"}], "brand_name": "Quetiapine Fumarate", "product_id": "50090-3983_51994a6c-153b-4f07-b3c9-4b7d2dfee326", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "50090-3983", "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": "300 mg/1"}], "application_number": "ANDA202674", "marketing_category": "ANDA", "marketing_start_date": "20160701", "listing_expiration_date": "20271231"}