quetiapine fumarate

Generic: quetiapine fumarate

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name quetiapine fumarate
Generic Name quetiapine fumarate
Labeler coupler llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

quetiapine fumarate 25 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1440
Product ID 67046-1440_348d4b09-9de2-24ef-e063-6394a90a698b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201190
Listing Expiration 2026-12-31
Marketing Start 2025-05-07

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 670461440
Hyphenated Format 67046-1440

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 ANDA201190 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1440-3)
source: ndc

Packages (1)

67046-1440-3 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1440-3)

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": "348d4b09-9de2-24ef-e063-6394a90a698b", "openfda": {"unii": ["2S3PL1B6UJ"], "rxcui": ["312744"], "spl_set_id": ["258eac65-69ed-404f-e063-6394a90a19ef"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1440-3)", "package_ndc": "67046-1440-3", "marketing_start_date": "20250507"}], "brand_name": "Quetiapine fumarate", "product_id": "67046-1440_348d4b09-9de2-24ef-e063-6394a90a698b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "67046-1440", "generic_name": "Quetiapine fumarate", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine fumarate", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "25 mg/1"}], "application_number": "ANDA201190", "marketing_category": "ANDA", "marketing_start_date": "20250507", "listing_expiration_date": "20261231"}