quetiapine fumarate

Generic: quetiapine fumarate

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name quetiapine fumarate
Generic Name quetiapine fumarate
Labeler direct_rx
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

quetiapine fumarate 400 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-477
Product ID 72189-477_2c4e047c-e102-db6f-e063-6394a90ac37a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091388
Listing Expiration 2026-12-31
Marketing Start 2023-05-30

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189477
Hyphenated Format 72189-477

Supplemental Identifiers

RxCUI
616483
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 ANDA091388 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (72189-477-30)
source: ndc

Packages (1)

72189-477-30 30 TABLET, FILM COATED in 1 BOTTLE (72189-477-30)

Ingredients (1)

quetiapine fumarate (400 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": "2c4e047c-e102-db6f-e063-6394a90ac37a", "openfda": {"unii": ["2S3PL1B6UJ"], "rxcui": ["616483"], "spl_set_id": ["fceb9f47-8da7-7138-e053-6294a90a5558"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (72189-477-30)", "package_ndc": "72189-477-30", "marketing_start_date": "20230530"}], "brand_name": "Quetiapine Fumarate", "product_id": "72189-477_2c4e047c-e102-db6f-e063-6394a90ac37a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "72189-477", "generic_name": "Quetiapine Fumarate", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine Fumarate", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "400 mg/1"}], "application_number": "ANDA091388", "marketing_category": "ANDA", "marketing_start_date": "20230530", "listing_expiration_date": "20261231"}