quetiapine fumarate

Generic: quetiapine fumarate

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name quetiapine fumarate
Generic Name quetiapine fumarate
Labeler proficient rx lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

quetiapine fumarate 100 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-020
Product ID 82804-020_2b387188-c2c1-4865-984c-341a358d1c6c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091388
Listing Expiration 2026-12-31
Marketing Start 2012-03-27

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82804020
Hyphenated Format 82804-020

Supplemental Identifiers

RxCUI
312743
UPC
0382804020300
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 ANDA091388 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (82804-020-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (82804-020-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (82804-020-90)
source: ndc

Packages (3)

82804-020-30 30 TABLET, FILM COATED in 1 BOTTLE (82804-020-30) 82804-020-60 60 TABLET, FILM COATED in 1 BOTTLE (82804-020-60) 82804-020-90 90 TABLET, FILM COATED in 1 BOTTLE (82804-020-90)

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": "2b387188-c2c1-4865-984c-341a358d1c6c", "openfda": {"upc": ["0382804020300"], "unii": ["2S3PL1B6UJ"], "rxcui": ["312743"], "spl_set_id": ["2b387188-c2c1-4865-984c-341a358d1c6c"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (82804-020-30)", "package_ndc": "82804-020-30", "marketing_start_date": "20231011"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (82804-020-60)", "package_ndc": "82804-020-60", "marketing_start_date": "20231011"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (82804-020-90)", "package_ndc": "82804-020-90", "marketing_start_date": "20231011"}], "brand_name": "Quetiapine Fumarate", "product_id": "82804-020_2b387188-c2c1-4865-984c-341a358d1c6c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "82804-020", "generic_name": "Quetiapine Fumarate", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine Fumarate", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "100 mg/1"}], "application_number": "ANDA091388", "marketing_category": "ANDA", "marketing_start_date": "20120327", "listing_expiration_date": "20261231"}