quetiapine

Generic: quetiapine

Labeler: bluepoint laboratories
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name quetiapine
Generic Name quetiapine
Labeler bluepoint laboratories
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

quetiapine fumarate 200 mg/1

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-600
Product ID 68001-600_487e93eb-c251-17da-e063-6294a90a6517
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215478
Listing Expiration 2027-12-31
Marketing Start 2023-11-01

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68001600
Hyphenated Format 68001-600

Supplemental Identifiers

RxCUI
721791 721794 721796 853201 895670
UPC
0368001602068 0368001599061 0368001600064 0368001601061 0368001598064
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 ANDA215478 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-600-06)
source: ndc

Packages (1)

68001-600-06 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-600-06)

Ingredients (1)

quetiapine fumarate (200 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": "487e93eb-c251-17da-e063-6294a90a6517", "openfda": {"upc": ["0368001602068", "0368001599061", "0368001600064", "0368001601061", "0368001598064"], "unii": ["2S3PL1B6UJ"], "rxcui": ["721791", "721794", "721796", "853201", "895670"], "spl_set_id": ["186c5cde-5066-4436-99ef-28049c12826b"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-600-06)", "package_ndc": "68001-600-06", "marketing_start_date": "20231128"}], "brand_name": "Quetiapine", "product_id": "68001-600_487e93eb-c251-17da-e063-6294a90a6517", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "68001-600", "generic_name": "Quetiapine", "labeler_name": "BluePoint Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "200 mg/1"}], "application_number": "ANDA215478", "marketing_category": "ANDA", "marketing_start_date": "20231101", "listing_expiration_date": "20271231"}