quetiapine fumarate

Generic: quetiapine fumarate

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name quetiapine fumarate
Generic Name quetiapine fumarate
Labeler advanced rx of tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

quetiapine fumarate 100 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0413
Product ID 80425-0413_1cfc689e-77dd-d388-e063-6394a90a81ea
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201109
Listing Expiration 2026-12-31
Marketing Start 2024-07-11

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250413
Hyphenated Format 80425-0413

Supplemental Identifiers

RxCUI
312743
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 ANDA201109 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (80425-0413-1)
  • 60 TABLET in 1 BOTTLE (80425-0413-2)
  • 90 TABLET in 1 BOTTLE (80425-0413-3)
source: ndc

Packages (3)

80425-0413-1 30 TABLET in 1 BOTTLE (80425-0413-1) 80425-0413-2 60 TABLET in 1 BOTTLE (80425-0413-2) 80425-0413-3 90 TABLET in 1 BOTTLE (80425-0413-3)

Ingredients (1)

quetiapine fumarate (100 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": "1cfc689e-77dd-d388-e063-6394a90a81ea", "openfda": {"unii": ["2S3PL1B6UJ"], "rxcui": ["312743"], "spl_set_id": ["1cfc847b-0d8d-fc94-e063-6394a90a311f"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (80425-0413-1)", "package_ndc": "80425-0413-1", "marketing_start_date": "20240711"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (80425-0413-2)", "package_ndc": "80425-0413-2", "marketing_start_date": "20240711"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (80425-0413-3)", "package_ndc": "80425-0413-3", "marketing_start_date": "20240711"}], "brand_name": "Quetiapine fumarate", "product_id": "80425-0413_1cfc689e-77dd-d388-e063-6394a90a81ea", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "80425-0413", "generic_name": "quetiapine fumarate", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine fumarate", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "100 mg/1"}], "application_number": "ANDA201109", "marketing_category": "ANDA", "marketing_start_date": "20240711", "listing_expiration_date": "20261231"}