quetiapine fumarate

Generic: quetiapine fumarate

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

Drug Facts

Product Profile

Brand Name quetiapine fumarate
Generic Name quetiapine fumarate
Labeler hikma pharmaceuticals usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

quetiapine fumarate 300 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-0223
Product ID 0054-0223_73eed8f1-3912-40e6-8084-d8498616ee5d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090749
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 00540223
Hyphenated Format 0054-0223

Supplemental Identifiers

RxCUI
312743 312744 312745 317174 616483 616487
UPC
0300540223212 0300540230258 0300540222253 0300540229252 0300540220259 0300540221256
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 ANDA090749 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (0054-0223-20) / 10 TABLET in 1 BLISTER PACK
  • 60 TABLET in 1 BOTTLE (0054-0223-21)
source: ndc

Packages (2)

0054-0223-20 10 BLISTER PACK in 1 CARTON (0054-0223-20) / 10 TABLET in 1 BLISTER PACK 0054-0223-21 60 TABLET in 1 BOTTLE (0054-0223-21)

Ingredients (1)

quetiapine fumarate (300 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": "73eed8f1-3912-40e6-8084-d8498616ee5d", "openfda": {"upc": ["0300540223212", "0300540230258", "0300540222253", "0300540229252", "0300540220259", "0300540221256"], "unii": ["2S3PL1B6UJ"], "rxcui": ["312743", "312744", "312745", "317174", "616483", "616487"], "spl_set_id": ["271e9fb7-3c70-43fc-8279-5adf189f3c22"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (0054-0223-20)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "0054-0223-20", "marketing_start_date": "20120327"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (0054-0223-21)", "package_ndc": "0054-0223-21", "marketing_start_date": "20120327"}], "brand_name": "Quetiapine Fumarate", "product_id": "0054-0223_73eed8f1-3912-40e6-8084-d8498616ee5d", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "0054-0223", "generic_name": "Quetiapine Fumarate", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine Fumarate", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "300 mg/1"}], "application_number": "ANDA090749", "marketing_category": "ANDA", "marketing_start_date": "20120327", "listing_expiration_date": "20261231"}