quetiapine

Generic: quetiapine

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

Drug Facts

Product Profile

Brand Name quetiapine
Generic Name quetiapine
Labeler coupler llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

quetiapine fumarate 200 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1623
Product ID 67046-1623_4615218b-35a5-a0f9-e063-6394a90a7c10
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215478
Listing Expiration 2026-12-31
Marketing Start 2025-12-16

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 670461623
Hyphenated Format 67046-1623

Supplemental Identifiers

RxCUI
721791
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 (source: ndc)
Generic Name quetiapine (source: ndc)
Application Number ANDA215478 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (67046-1623-3)
source: ndc

Packages (1)

67046-1623-3 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (67046-1623-3)

Ingredients (1)

quetiapine fumarate (200 mg/1)

Linked Drug Pages (1)

Quetiapine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4615218b-35a5-a0f9-e063-6394a90a7c10", "openfda": {"unii": ["2S3PL1B6UJ"], "rxcui": ["721791"], "spl_set_id": ["461523b5-8d12-9d96-e063-6394a90ad4c2"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (67046-1623-3)", "package_ndc": "67046-1623-3", "marketing_start_date": "20251216"}], "brand_name": "Quetiapine", "product_id": "67046-1623_4615218b-35a5-a0f9-e063-6394a90a7c10", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "67046-1623", "generic_name": "Quetiapine", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "200 mg/1"}], "application_number": "ANDA215478", "marketing_category": "ANDA", "marketing_start_date": "20251216", "listing_expiration_date": "20261231"}