quetiapine fumarate

Generic: quetiapine

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name quetiapine fumarate
Generic Name quetiapine
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

quetiapine fumarate 200 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-875
Product ID 65862-875_631d518f-bb71-4848-98a6-f9335dc5b33b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207655
Listing Expiration 2026-12-31
Marketing Start 2017-11-29

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862875
Hyphenated Format 65862-875

Supplemental Identifiers

RxCUI
721791 721794 721796 853201 895670
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 fumarate (source: ndc)
Generic Name quetiapine (source: ndc)
Application Number ANDA207655 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-875-01)
  • 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-875-05)
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-875-60)
source: ndc

Packages (3)

65862-875-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-875-01) 65862-875-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-875-05) 65862-875-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-875-60)

Ingredients (1)

quetiapine fumarate (200 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": "631d518f-bb71-4848-98a6-f9335dc5b33b", "openfda": {"unii": ["2S3PL1B6UJ"], "rxcui": ["721791", "721794", "721796", "853201", "895670"], "spl_set_id": ["6562eb60-0d70-4909-bd07-88d5c9241516"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-875-01)", "package_ndc": "65862-875-01", "marketing_start_date": "20171129"}, {"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-875-05)", "package_ndc": "65862-875-05", "marketing_start_date": "20171129"}, {"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-875-60)", "package_ndc": "65862-875-60", "marketing_start_date": "20171129"}], "brand_name": "Quetiapine Fumarate", "product_id": "65862-875_631d518f-bb71-4848-98a6-f9335dc5b33b", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "65862-875", "generic_name": "Quetiapine", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine Fumarate", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "200 mg/1"}], "application_number": "ANDA207655", "marketing_category": "ANDA", "marketing_start_date": "20171129", "listing_expiration_date": "20261231"}