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
Routes
ORAL
Active Ingredients

quetiapine fumarate 50 mg/1

Manufacturer
Preferred Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68788-8778
Product ID 68788-8778_25bd0504-bb8c-460d-a675-555173b53820
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201109
Listing Expiration 2027-12-31
Marketing Start 2024-12-10

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888778
Hyphenated Format 68788-8778

Supplemental Identifiers

RxCUI
616487
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 ANDA201109 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68788-8778-1)
  • 30 TABLET in 1 BOTTLE (68788-8778-3)
  • 60 TABLET in 1 BOTTLE (68788-8778-6)
  • 120 TABLET in 1 BOTTLE (68788-8778-8)
  • 90 TABLET in 1 BOTTLE (68788-8778-9)
source: ndc

Packages (5)

68788-8778-1 100 TABLET in 1 BOTTLE (68788-8778-1) 68788-8778-3 30 TABLET in 1 BOTTLE (68788-8778-3) 68788-8778-6 60 TABLET in 1 BOTTLE (68788-8778-6) 68788-8778-8 120 TABLET in 1 BOTTLE (68788-8778-8) 68788-8778-9 90 TABLET in 1 BOTTLE (68788-8778-9)

Ingredients (1)

quetiapine fumarate (50 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": "25bd0504-bb8c-460d-a675-555173b53820", "openfda": {"unii": ["2S3PL1B6UJ"], "rxcui": ["616487"], "spl_set_id": ["1fe839fa-c566-4374-997f-f5b9d97b5fb8"], "manufacturer_name": ["Preferred Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68788-8778-1)", "package_ndc": "68788-8778-1", "marketing_start_date": "20241210"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68788-8778-3)", "package_ndc": "68788-8778-3", "marketing_start_date": "20241210"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (68788-8778-6)", "package_ndc": "68788-8778-6", "marketing_start_date": "20241210"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (68788-8778-8)", "package_ndc": "68788-8778-8", "marketing_start_date": "20241210"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68788-8778-9)", "package_ndc": "68788-8778-9", "marketing_start_date": "20241210"}], "brand_name": "Quetiapine fumarate", "product_id": "68788-8778_25bd0504-bb8c-460d-a675-555173b53820", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "68788-8778", "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": "50 mg/1"}], "application_number": "ANDA201109", "marketing_category": "ANDA", "marketing_start_date": "20241210", "listing_expiration_date": "20271231"}