QUETIAPINE FUMARATE

Generic: QUETIAPINE FUMARATE

Labeler: Bluepoint Laboratories
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive

Drug Facts

Product Profile

Brand Name QUETIAPINE FUMARATE
Generic Name QUETIAPINE FUMARATE
Labeler Bluepoint Laboratories
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

QUETIAPINE FUMARATE 50 mg/1

Identifiers & Regulatory

Product NDC 68001-511
Product ID 68001-511_303ec748-0ce2-d2bb-e063-6394a90a5813
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206252
Marketing Start 2021-08-31
Marketing End 2026-02-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68001511
Hyphenated Format 68001-511

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 ANDA206252 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-511-06)
source: ndc

Packages (1)

68001-511-06 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-511-06)

Ingredients (1)

QUETIAPINE FUMARATE (50 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": "303ec748-0ce2-d2bb-e063-6394a90a5813", "openfda": {"unii": ["2S3PL1B6UJ"], "rxcui": ["853201"], "spl_set_id": ["529c41df-70e1-4f18-ad36-05e169fa0a07"], "manufacturer_name": ["Bluepoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-511-06)", "package_ndc": "68001-511-06", "marketing_end_date": "20260228", "marketing_start_date": "20210831"}], "brand_name": "QUETIAPINE FUMARATE", "product_id": "68001-511_303ec748-0ce2-d2bb-e063-6394a90a5813", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "68001-511", "generic_name": "QUETIAPINE FUMARATE", "labeler_name": "Bluepoint Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "QUETIAPINE FUMARATE", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "50 mg/1"}], "application_number": "ANDA206252", "marketing_category": "ANDA", "marketing_end_date": "20260228", "marketing_start_date": "20210831"}