quetiapine fumarate

Generic: quetiapine fumarate

Labeler: ingenus pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

quetiapine fumarate 150 mg/1

Manufacturer
Ingenus Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 50742-636
Product ID 50742-636_57efb2c4-97c7-4f4b-8e1f-e73ec6d6c176
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208947
Listing Expiration 2026-12-31
Marketing Start 2017-08-31

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50742636
Hyphenated Format 50742-636

Supplemental Identifiers

RxCUI
721791 721794 721796 853201 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 ANDA208947 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-636-10)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-636-30)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-636-60)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-636-90)
source: ndc

Packages (4)

50742-636-10 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-636-10) 50742-636-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-636-30) 50742-636-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-636-60) 50742-636-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-636-90)

Ingredients (1)

quetiapine fumarate (150 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": "57efb2c4-97c7-4f4b-8e1f-e73ec6d6c176", "openfda": {"unii": ["2S3PL1B6UJ"], "rxcui": ["721791", "721794", "721796", "853201", "895670"], "spl_set_id": ["8923c441-c9aa-4b30-89d7-dbaaa7f66656"], "manufacturer_name": ["Ingenus Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-636-10)", "package_ndc": "50742-636-10", "marketing_start_date": "20170831"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-636-30)", "package_ndc": "50742-636-30", "marketing_start_date": "20170831"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-636-60)", "package_ndc": "50742-636-60", "marketing_start_date": "20170831"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-636-90)", "package_ndc": "50742-636-90", "marketing_start_date": "20170831"}], "brand_name": "Quetiapine Fumarate", "product_id": "50742-636_57efb2c4-97c7-4f4b-8e1f-e73ec6d6c176", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "50742-636", "generic_name": "quetiapine fumarate", "labeler_name": "Ingenus Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine Fumarate", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "150 mg/1"}], "application_number": "ANDA208947", "marketing_category": "ANDA", "marketing_start_date": "20170831", "listing_expiration_date": "20261231"}