quetiapine fumarate

Generic: quetiapine fumarate

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name quetiapine fumarate
Generic Name quetiapine fumarate
Labeler macleods pharmaceuticals limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

quetiapine fumarate 400 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-105
Product ID 33342-105_e8676630-c511-427b-af62-969f338d96cf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203359
Listing Expiration 2026-12-31
Marketing Start 2016-06-14

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342105
Hyphenated Format 33342-105

Supplemental Identifiers

RxCUI
312743 312744 312745 317174 616483 616487
UPC
0333342101440 0333342103154 0333342103444 0333342104151
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 ANDA203359 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (33342-105-11)
  • 500 TABLET, FILM COATED in 1 BOTTLE (33342-105-15)
  • 9 BLISTER PACK in 1 CARTON (33342-105-39) / 10 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (3)

33342-105-11 100 TABLET, FILM COATED in 1 BOTTLE (33342-105-11) 33342-105-15 500 TABLET, FILM COATED in 1 BOTTLE (33342-105-15) 33342-105-39 9 BLISTER PACK in 1 CARTON (33342-105-39) / 10 TABLET, FILM COATED in 1 BLISTER PACK

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": "e8676630-c511-427b-af62-969f338d96cf", "openfda": {"upc": ["0333342101440", "0333342103154", "0333342103444", "0333342104151"], "unii": ["2S3PL1B6UJ"], "rxcui": ["312743", "312744", "312745", "317174", "616483", "616487"], "spl_set_id": ["531cbe20-dff2-4983-9788-4543079f83ff"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (33342-105-11)", "package_ndc": "33342-105-11", "marketing_start_date": "20160614"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (33342-105-15)", "package_ndc": "33342-105-15", "marketing_start_date": "20160614"}, {"sample": false, "description": "9 BLISTER PACK in 1 CARTON (33342-105-39)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "33342-105-39", "marketing_start_date": "20160614"}], "brand_name": "Quetiapine fumarate", "product_id": "33342-105_e8676630-c511-427b-af62-969f338d96cf", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "33342-105", "generic_name": "Quetiapine fumarate", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine fumarate", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "400 mg/1"}], "application_number": "ANDA203359", "marketing_category": "ANDA", "marketing_start_date": "20160614", "listing_expiration_date": "20261231"}