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 25 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-452
Product ID 63187-452_72502e4b-1ebb-4a61-aecf-f319be11ce9b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202152
Listing Expiration 2026-12-31
Marketing Start 2012-03-26

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63187452
Hyphenated Format 63187-452

Supplemental Identifiers

RxCUI
312744
UPC
0363187452308
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 ANDA202152 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 3 TABLET, FILM COATED in 1 BOTTLE (63187-452-03)
  • 30 TABLET, FILM COATED in 1 BOTTLE (63187-452-30)
source: ndc

Packages (2)

63187-452-03 3 TABLET, FILM COATED in 1 BOTTLE (63187-452-03) 63187-452-30 30 TABLET, FILM COATED in 1 BOTTLE (63187-452-30)

Ingredients (1)

quetiapine fumarate (25 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": "72502e4b-1ebb-4a61-aecf-f319be11ce9b", "openfda": {"upc": ["0363187452308"], "unii": ["2S3PL1B6UJ"], "rxcui": ["312744"], "spl_set_id": ["1a147d6c-8af8-4379-8a13-1864a9a79b84"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "3 TABLET, FILM COATED in 1 BOTTLE (63187-452-03)", "package_ndc": "63187-452-03", "marketing_start_date": "20170501"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (63187-452-30)", "package_ndc": "63187-452-30", "marketing_start_date": "20170501"}], "brand_name": "Quetiapine fumarate", "product_id": "63187-452_72502e4b-1ebb-4a61-aecf-f319be11ce9b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "63187-452", "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": "25 mg/1"}], "application_number": "ANDA202152", "marketing_category": "ANDA", "marketing_start_date": "20120326", "listing_expiration_date": "20261231"}