seroquel

Generic: quetiapine

Labeler: h2-pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name seroquel
Generic Name quetiapine
Labeler h2-pharma, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

quetiapine fumarate 25 mg/1

Manufacturer
H2-Pharma, LLC

Identifiers & Regulatory

Product NDC 61269-250
Product ID 61269-250_c66b0a69-3827-4a3f-a506-55b674865b2b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020639
Listing Expiration 2026-12-31
Marketing Start 1997-10-01

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61269250
Hyphenated Format 61269-250

Supplemental Identifiers

UNII
2S3PL1B6UJ

Packaging Origin

Original Packager
true

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 seroquel (source: ndc)
Generic Name quetiapine (source: ndc)
Application Number NDA020639 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (61269-250-10)
source: ndc

Packages (1)

61269-250-10 100 TABLET, FILM COATED in 1 BOTTLE (61269-250-10)

Ingredients (1)

quetiapine fumarate (25 mg/1)

Linked Drug Pages (1)

SEROQUEL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c66b0a69-3827-4a3f-a506-55b674865b2b", "openfda": {"unii": ["2S3PL1B6UJ"], "spl_set_id": ["8ae62aaf-f8c5-417f-baac-0098369ca322"], "manufacturer_name": ["H2-Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (61269-250-10)", "package_ndc": "61269-250-10", "marketing_start_date": "19971001"}], "brand_name": "SEROQUEL", "product_id": "61269-250_c66b0a69-3827-4a3f-a506-55b674865b2b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "61269-250", "generic_name": "quetiapine", "labeler_name": "H2-Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SEROQUEL", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "25 mg/1"}], "application_number": "NDA020639", "marketing_category": "NDA", "marketing_start_date": "19971001", "listing_expiration_date": "20261231"}