seroquel xr

Generic: quetiapine

Labeler: h2-pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name seroquel xr
Generic Name quetiapine
Labeler h2-pharma, llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

quetiapine fumarate 50 mg/1

Manufacturer
H2-Pharma, LLC

Identifiers & Regulatory

Product NDC 61269-270
Product ID 61269-270_429359fa-9bf0-42d7-af7b-6b153d1c03b8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022047
Listing Expiration 2026-12-31
Marketing Start 2009-02-01

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61269270
Hyphenated Format 61269-270

Supplemental Identifiers

RxCUI
721791 721793 721794 721795 721796 721797 853201 853202 895670 895671
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 seroquel xr (source: ndc)
Generic Name quetiapine (source: ndc)
Application Number NDA022047 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (61269-270-60)
source: ndc

Packages (1)

61269-270-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (61269-270-60)

Ingredients (1)

quetiapine fumarate (50 mg/1)

Linked Drug Pages (1)

SEROQUEL XR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "429359fa-9bf0-42d7-af7b-6b153d1c03b8", "openfda": {"unii": ["2S3PL1B6UJ"], "rxcui": ["721791", "721793", "721794", "721795", "721796", "721797", "853201", "853202", "895670", "895671"], "spl_set_id": ["ab959a35-d0ba-4f18-8f2e-6619d88b16e3"], "manufacturer_name": ["H2-Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (61269-270-60)", "package_ndc": "61269-270-60", "marketing_start_date": "20090201"}], "brand_name": "SEROQUEL XR", "product_id": "61269-270_429359fa-9bf0-42d7-af7b-6b153d1c03b8", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "61269-270", "generic_name": "quetiapine", "labeler_name": "H2-Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SEROQUEL", "brand_name_suffix": "XR", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "50 mg/1"}], "application_number": "NDA022047", "marketing_category": "NDA", "marketing_start_date": "20090201", "listing_expiration_date": "20261231"}