quetiapine

Generic: quetiapine

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

Drug Facts

Product Profile

Brand Name quetiapine
Generic Name quetiapine
Labeler macleods pharmaceuticals limited
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

quetiapine fumarate 400 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-137
Product ID 33342-137_fb91b782-1195-4212-b130-9e078dc47dcd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204253
Listing Expiration 2026-12-31
Marketing Start 2017-11-01

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342137
Hyphenated Format 33342-137

Supplemental Identifiers

RxCUI
721791 721794 721796 895670
UPC
0333342134158 0333342137098 0333342136091 0333342135094 0333342136152 0333342137159 0333342134097
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 (source: ndc)
Generic Name quetiapine (source: ndc)
Application Number ANDA204253 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-137-09)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-137-15)
source: ndc

Packages (2)

33342-137-09 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-137-09) 33342-137-15 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-137-15)

Ingredients (1)

quetiapine fumarate (400 mg/1)

Linked Drug Pages (1)

QUETIAPINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "fb91b782-1195-4212-b130-9e078dc47dcd", "openfda": {"upc": ["0333342134158", "0333342137098", "0333342136091", "0333342135094", "0333342136152", "0333342137159", "0333342134097"], "unii": ["2S3PL1B6UJ"], "rxcui": ["721791", "721794", "721796", "895670"], "spl_set_id": ["d699b8c7-8a1c-44ed-85d8-c821a9c8c848"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-137-09)", "package_ndc": "33342-137-09", "marketing_start_date": "20171101"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-137-15)", "package_ndc": "33342-137-15", "marketing_start_date": "20171101"}], "brand_name": "QUETIAPINE", "product_id": "33342-137_fb91b782-1195-4212-b130-9e078dc47dcd", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "33342-137", "generic_name": "QUETIAPINE", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "QUETIAPINE", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "400 mg/1"}], "application_number": "ANDA204253", "marketing_category": "ANDA", "marketing_start_date": "20171101", "listing_expiration_date": "20261231"}