seroquel

Generic: quetiapine

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

Drug Facts

Product Profile

Brand Name seroquel
Generic Name quetiapine
Labeler astrazeneca pharmaceuticals lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

quetiapine fumarate 400 mg/1

Manufacturer
AstraZeneca Pharmaceuticals LP

Identifiers & Regulatory

Product NDC 0310-0279
Product ID 0310-0279_aef69992-4a20-4d55-b85c-7c0799619ce6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020639
Marketing Start 2006-02-13
Marketing End 2026-10-31

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03100279
Hyphenated Format 0310-0279

Supplemental Identifiers

RxCUI
153638 153639 153640 284509 312743 312744 312745 317174 616483 616485 616487 616489
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 (source: ndc)
Generic Name quetiapine (source: ndc)
Application Number NDA020639 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (0310-0279-10)
source: ndc

Packages (1)

0310-0279-10 100 TABLET, FILM COATED in 1 BOTTLE (0310-0279-10)

Ingredients (1)

quetiapine fumarate (400 mg/1)

Linked Drug Pages (1)

SEROQUEL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "aef69992-4a20-4d55-b85c-7c0799619ce6", "openfda": {"unii": ["2S3PL1B6UJ"], "rxcui": ["153638", "153639", "153640", "284509", "312743", "312744", "312745", "317174", "616483", "616485", "616487", "616489"], "spl_set_id": ["0584dda8-bc3c-48fe-1a90-79608f78e8a0"], "manufacturer_name": ["AstraZeneca Pharmaceuticals LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (0310-0279-10)", "package_ndc": "0310-0279-10", "marketing_end_date": "20261031", "marketing_start_date": "20060213"}], "brand_name": "SEROQUEL", "product_id": "0310-0279_aef69992-4a20-4d55-b85c-7c0799619ce6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "0310-0279", "generic_name": "quetiapine", "labeler_name": "AstraZeneca Pharmaceuticals LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SEROQUEL", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "400 mg/1"}], "application_number": "NDA020639", "marketing_category": "NDA", "marketing_end_date": "20261031", "marketing_start_date": "20060213"}