quetiapine fumarate

Generic: quetiapine fumarate

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

Drug Facts

Product Profile

Brand Name quetiapine fumarate
Generic Name quetiapine fumarate
Labeler preferred pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

quetiapine fumarate 300 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8530
Product ID 68788-8530_76df809c-e4b7-4bc7-85c4-482212f459b2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091388
Listing Expiration 2026-12-31
Marketing Start 2023-10-06

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888530
Hyphenated Format 68788-8530

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 ANDA091388 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (68788-8530-3)
  • 60 TABLET, FILM COATED in 1 BOTTLE (68788-8530-6)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68788-8530-9)
source: ndc

Packages (3)

68788-8530-3 30 TABLET, FILM COATED in 1 BOTTLE (68788-8530-3) 68788-8530-6 60 TABLET, FILM COATED in 1 BOTTLE (68788-8530-6) 68788-8530-9 90 TABLET, FILM COATED in 1 BOTTLE (68788-8530-9)

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": "76df809c-e4b7-4bc7-85c4-482212f459b2", "openfda": {"unii": ["2S3PL1B6UJ"], "rxcui": ["312745"], "spl_set_id": ["8acc0ed3-6e4f-4799-8252-5a163938fddc"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68788-8530-3)", "package_ndc": "68788-8530-3", "marketing_start_date": "20231006"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68788-8530-6)", "package_ndc": "68788-8530-6", "marketing_start_date": "20231006"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68788-8530-9)", "package_ndc": "68788-8530-9", "marketing_start_date": "20231006"}], "brand_name": "Quetiapine Fumarate", "product_id": "68788-8530_76df809c-e4b7-4bc7-85c4-482212f459b2", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "68788-8530", "generic_name": "Quetiapine Fumarate", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine Fumarate", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "300 mg/1"}], "application_number": "ANDA091388", "marketing_category": "ANDA", "marketing_start_date": "20231006", "listing_expiration_date": "20261231"}