seroquel xr

Generic: quetiapine

Labeler: astrazeneca pharmaceuticals lp
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name seroquel xr
Generic Name quetiapine
Labeler astrazeneca pharmaceuticals lp
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

quetiapine fumarate 300 mg/1

Manufacturer
AstraZeneca Pharmaceuticals LP

Identifiers & Regulatory

Product NDC 0310-0283
Product ID 0310-0283_8e78eabf-6ff9-409b-ba1b-d9cb8d4f3fe0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022047
Marketing Start 2007-07-16
Marketing End 2027-01-31

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03100283
Hyphenated Format 0310-0283

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
  • 300 mg/1
source: ndc
Packaging
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (0310-0283-60)
source: ndc

Packages (1)

0310-0283-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (0310-0283-60)

Ingredients (1)

quetiapine fumarate (300 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": "8e78eabf-6ff9-409b-ba1b-d9cb8d4f3fe0", "openfda": {"unii": ["2S3PL1B6UJ"], "rxcui": ["721791", "721793", "721794", "721795", "721796", "721797", "853201", "853202", "895670", "895671"], "spl_set_id": ["473a3ac4-67f4-4782-baa9-7f9bdd8761f4"], "manufacturer_name": ["AstraZeneca Pharmaceuticals LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (0310-0283-60)", "package_ndc": "0310-0283-60", "marketing_end_date": "20270131", "marketing_start_date": "20070716"}], "brand_name": "SEROQUEL XR", "product_id": "0310-0283_8e78eabf-6ff9-409b-ba1b-d9cb8d4f3fe0", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "0310-0283", "generic_name": "quetiapine", "labeler_name": "AstraZeneca Pharmaceuticals LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SEROQUEL", "brand_name_suffix": "XR", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "300 mg/1"}], "application_number": "NDA022047", "marketing_category": "NDA", "marketing_end_date": "20270131", "marketing_start_date": "20070716"}