quetiapine fumarate

Generic: quetiapine fumarate

Labeler: ncs healthcare of ky, llc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name quetiapine fumarate
Generic Name quetiapine fumarate
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

quetiapine fumarate 400 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8568
Product ID 0615-8568_9f55185f-8471-4477-97b2-b61dd50c8b44
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202674
Listing Expiration 2026-12-31
Marketing Start 2016-07-01

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06158568
Hyphenated Format 0615-8568

Supplemental Identifiers

RxCUI
312743 312744 312745 317174 616483 616487
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 ANDA202674 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8568-39)
source: ndc

Packages (1)

0615-8568-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8568-39)

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": "9f55185f-8471-4477-97b2-b61dd50c8b44", "openfda": {"unii": ["2S3PL1B6UJ"], "rxcui": ["312743", "312744", "312745", "317174", "616483", "616487"], "spl_set_id": ["d73655d3-4b3f-40b4-92cb-053ad4f21a92"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8568-39)", "package_ndc": "0615-8568-39", "marketing_start_date": "20250218"}], "brand_name": "Quetiapine Fumarate", "product_id": "0615-8568_9f55185f-8471-4477-97b2-b61dd50c8b44", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "0615-8568", "generic_name": "Quetiapine Fumarate", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine Fumarate", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "400 mg/1"}], "application_number": "ANDA202674", "marketing_category": "ANDA", "marketing_start_date": "20160701", "listing_expiration_date": "20261231"}