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 25 mg/1

Manufacturer
: Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8764
Product ID 68788-8764_6621210b-edd5-46f6-aa72-f4befa35bccc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201109
Listing Expiration 2027-12-31
Marketing Start 2024-11-11

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888764
Hyphenated Format 68788-8764

Supplemental Identifiers

RxCUI
312744
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
  • 25 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68788-8764-1)
  • 30 TABLET in 1 BOTTLE (68788-8764-3)
  • 60 TABLET in 1 BOTTLE (68788-8764-6)
  • 120 TABLET in 1 BOTTLE (68788-8764-8)
  • 90 TABLET in 1 BOTTLE (68788-8764-9)
source: ndc

Packages (5)

68788-8764-1 100 TABLET in 1 BOTTLE (68788-8764-1) 68788-8764-3 30 TABLET in 1 BOTTLE (68788-8764-3) 68788-8764-6 60 TABLET in 1 BOTTLE (68788-8764-6) 68788-8764-8 120 TABLET in 1 BOTTLE (68788-8764-8) 68788-8764-9 90 TABLET in 1 BOTTLE (68788-8764-9)

Ingredients (1)

quetiapine fumarate (25 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": "6621210b-edd5-46f6-aa72-f4befa35bccc", "openfda": {"unii": ["2S3PL1B6UJ"], "rxcui": ["312744"], "spl_set_id": ["f3c91d05-038b-40f4-8c1f-2910773ec567"], "manufacturer_name": [": Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68788-8764-1)", "package_ndc": "68788-8764-1", "marketing_start_date": "20241111"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68788-8764-3)", "package_ndc": "68788-8764-3", "marketing_start_date": "20241111"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (68788-8764-6)", "package_ndc": "68788-8764-6", "marketing_start_date": "20241111"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (68788-8764-8)", "package_ndc": "68788-8764-8", "marketing_start_date": "20241111"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68788-8764-9)", "package_ndc": "68788-8764-9", "marketing_start_date": "20241111"}], "brand_name": "Quetiapine fumarate", "product_id": "68788-8764_6621210b-edd5-46f6-aa72-f4befa35bccc", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "68788-8764", "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": "25 mg/1"}], "application_number": "ANDA201109", "marketing_category": "ANDA", "marketing_start_date": "20241111", "listing_expiration_date": "20271231"}