quetiapine fumarate

Generic: quetiapine fumarate

Labeler: xlcare pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name quetiapine fumarate
Generic Name quetiapine fumarate
Labeler xlcare pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

quetiapine fumarate 400 mg/1

Manufacturer
XLCare Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 72865-269
Product ID 72865-269_315311f6-d86b-8dc1-e063-6294a90a5566
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204316
Listing Expiration 2026-12-31
Marketing Start 2024-02-02

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72865269
Hyphenated Format 72865-269

Supplemental Identifiers

RxCUI
312743 312744 312745 317174 616483 616487
UPC
0372865269015 0372865266014 0372865267011 0372865268605 0372865264010 0372865265017
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 ANDA204316 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (72865-269-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (72865-269-05)
  • 90 TABLET, FILM COATED in 1 BOTTLE (72865-269-90)
source: ndc

Packages (3)

72865-269-01 100 TABLET, FILM COATED in 1 BOTTLE (72865-269-01) 72865-269-05 500 TABLET, FILM COATED in 1 BOTTLE (72865-269-05) 72865-269-90 90 TABLET, FILM COATED in 1 BOTTLE (72865-269-90)

Ingredients (1)

quetiapine fumarate (400 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": "315311f6-d86b-8dc1-e063-6294a90a5566", "openfda": {"upc": ["0372865269015", "0372865266014", "0372865267011", "0372865268605", "0372865264010", "0372865265017"], "unii": ["2S3PL1B6UJ"], "rxcui": ["312743", "312744", "312745", "317174", "616483", "616487"], "spl_set_id": ["070faf07-0ce7-4354-8643-9d222b72ecad"], "manufacturer_name": ["XLCare Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (72865-269-01)", "package_ndc": "72865-269-01", "marketing_start_date": "20240202"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (72865-269-05)", "package_ndc": "72865-269-05", "marketing_start_date": "20240202"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (72865-269-90)", "package_ndc": "72865-269-90", "marketing_start_date": "20240722"}], "brand_name": "Quetiapine Fumarate", "product_id": "72865-269_315311f6-d86b-8dc1-e063-6294a90a5566", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "72865-269", "generic_name": "Quetiapine Fumarate", "labeler_name": "XLCare Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine Fumarate", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "400 mg/1"}], "application_number": "ANDA204316", "marketing_category": "ANDA", "marketing_start_date": "20240202", "listing_expiration_date": "20261231"}