quetiapine fumarate

Generic: quetiapine fumarate

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name quetiapine fumarate
Generic Name quetiapine fumarate
Labeler bryant ranch prepack
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

quetiapine fumarate 50 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-1353
Product ID 71335-1353_a2688211-bc1c-463d-90e5-47476a140965
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202674
Listing Expiration 2026-12-31
Marketing Start 2016-07-01

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 713351353
Hyphenated Format 71335-1353

Supplemental Identifiers

RxCUI
616487
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 ANDA202674 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (71335-1353-1)
  • 60 TABLET, FILM COATED in 1 BOTTLE (71335-1353-2)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71335-1353-3)
  • 25 TABLET, FILM COATED in 1 BOTTLE (71335-1353-4)
  • 120 TABLET, FILM COATED in 1 BOTTLE (71335-1353-5)
source: ndc

Packages (5)

71335-1353-1 30 TABLET, FILM COATED in 1 BOTTLE (71335-1353-1) 71335-1353-2 60 TABLET, FILM COATED in 1 BOTTLE (71335-1353-2) 71335-1353-3 90 TABLET, FILM COATED in 1 BOTTLE (71335-1353-3) 71335-1353-4 25 TABLET, FILM COATED in 1 BOTTLE (71335-1353-4) 71335-1353-5 120 TABLET, FILM COATED in 1 BOTTLE (71335-1353-5)

Ingredients (1)

quetiapine fumarate (50 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": "a2688211-bc1c-463d-90e5-47476a140965", "openfda": {"unii": ["2S3PL1B6UJ"], "rxcui": ["616487"], "spl_set_id": ["1618989e-2e6b-49ff-81b5-cf80d1dcfab4"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71335-1353-1)", "package_ndc": "71335-1353-1", "marketing_start_date": "20191105"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71335-1353-2)", "package_ndc": "71335-1353-2", "marketing_start_date": "20191003"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71335-1353-3)", "package_ndc": "71335-1353-3", "marketing_start_date": "20190926"}, {"sample": false, "description": "25 TABLET, FILM COATED in 1 BOTTLE (71335-1353-4)", "package_ndc": "71335-1353-4", "marketing_start_date": "20240520"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (71335-1353-5)", "package_ndc": "71335-1353-5", "marketing_start_date": "20240520"}], "brand_name": "Quetiapine Fumarate", "product_id": "71335-1353_a2688211-bc1c-463d-90e5-47476a140965", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "71335-1353", "generic_name": "Quetiapine Fumarate", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine Fumarate", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "50 mg/1"}], "application_number": "ANDA202674", "marketing_category": "ANDA", "marketing_start_date": "20160701", "listing_expiration_date": "20261231"}