quetiapine fumarate

Generic: quetiapine fumarate

Labeler: accord healthcare inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name quetiapine fumarate
Generic Name quetiapine fumarate
Labeler accord healthcare inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

quetiapine fumarate 200 mg/1

Manufacturer
Accord Healthcare Inc.

Identifiers & Regulatory

Product NDC 16729-095
Product ID 16729-095_4390e24f-daa6-84a2-e063-6294a90a48ab
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090681
Listing Expiration 2026-12-31
Marketing Start 2019-01-01

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16729095
Hyphenated Format 16729-095

Supplemental Identifiers

RxCUI
721791 721794 721796 895670
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 quetiapine fumarate (source: ndc)
Generic Name quetiapine fumarate (source: ndc)
Application Number ANDA090681 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-095-12)
source: ndc

Packages (1)

16729-095-12 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-095-12)

Ingredients (1)

quetiapine fumarate (200 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": "4390e24f-daa6-84a2-e063-6294a90a48ab", "openfda": {"unii": ["2S3PL1B6UJ"], "rxcui": ["721791", "721794", "721796", "895670"], "spl_set_id": ["3ffe0294-3959-2755-e054-00144ff8d46c"], "manufacturer_name": ["Accord Healthcare Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-095-12)", "package_ndc": "16729-095-12", "marketing_start_date": "20190101"}], "brand_name": "QUETIAPINE FUMARATE", "product_id": "16729-095_4390e24f-daa6-84a2-e063-6294a90a48ab", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "16729-095", "generic_name": "QUETIAPINE FUMARATE", "labeler_name": "Accord Healthcare Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "QUETIAPINE FUMARATE", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "200 mg/1"}], "application_number": "ANDA090681", "marketing_category": "ANDA", "marketing_start_date": "20190101", "listing_expiration_date": "20261231"}