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 50 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-7813
Product ID 68788-7813_53789440-dcb0-475b-8b86-4033a2557695
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201504
Listing Expiration 2026-12-31
Marketing Start 2020-10-30

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687887813
Hyphenated Format 68788-7813

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 ANDA201504 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (68788-7813-1)
  • 30 TABLET, FILM COATED in 1 BOTTLE (68788-7813-3)
  • 60 TABLET, FILM COATED in 1 BOTTLE (68788-7813-6)
  • 120 TABLET, FILM COATED in 1 BOTTLE (68788-7813-8)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68788-7813-9)
source: ndc

Packages (5)

68788-7813-1 100 TABLET, FILM COATED in 1 BOTTLE (68788-7813-1) 68788-7813-3 30 TABLET, FILM COATED in 1 BOTTLE (68788-7813-3) 68788-7813-6 60 TABLET, FILM COATED in 1 BOTTLE (68788-7813-6) 68788-7813-8 120 TABLET, FILM COATED in 1 BOTTLE (68788-7813-8) 68788-7813-9 90 TABLET, FILM COATED in 1 BOTTLE (68788-7813-9)

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": "53789440-dcb0-475b-8b86-4033a2557695", "openfda": {"unii": ["2S3PL1B6UJ"], "rxcui": ["616487"], "spl_set_id": ["717b55c4-a23f-4d74-8023-0f4e14d89ec8"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (68788-7813-1)", "package_ndc": "68788-7813-1", "marketing_start_date": "20201030"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68788-7813-3)", "package_ndc": "68788-7813-3", "marketing_start_date": "20201030"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68788-7813-6)", "package_ndc": "68788-7813-6", "marketing_start_date": "20201030"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (68788-7813-8)", "package_ndc": "68788-7813-8", "marketing_start_date": "20201030"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68788-7813-9)", "package_ndc": "68788-7813-9", "marketing_start_date": "20201030"}], "brand_name": "Quetiapine Fumarate", "product_id": "68788-7813_53789440-dcb0-475b-8b86-4033a2557695", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "68788-7813", "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": "ANDA201504", "marketing_category": "ANDA", "marketing_start_date": "20201030", "listing_expiration_date": "20261231"}