quetiapine fumarate

Generic: quetiapine fumarate

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

Drug Facts

Product Profile

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

quetiapine fumarate 400 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-495
Product ID 65862-495_f759dcc0-2e6c-4743-8772-3f05602db2a3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091388
Listing Expiration 2026-12-31
Marketing Start 2012-03-27

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862495
Hyphenated Format 65862-495

Supplemental Identifiers

RxCUI
312743 312744 312745 317174 389201 616483 616487
UPC
0365862490018 0365862489012 0365862491015
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 fumarate (source: ndc)
Application Number ANDA091388 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (65862-495-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (65862-495-05)
  • 10 BLISTER PACK in 1 CARTON (65862-495-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (3)

65862-495-01 100 TABLET, FILM COATED in 1 BOTTLE (65862-495-01) 65862-495-05 500 TABLET, FILM COATED in 1 BOTTLE (65862-495-05) 65862-495-10 10 BLISTER PACK in 1 CARTON (65862-495-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

quetiapine fumarate (400 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": "f759dcc0-2e6c-4743-8772-3f05602db2a3", "openfda": {"upc": ["0365862490018", "0365862489012", "0365862491015"], "unii": ["2S3PL1B6UJ"], "rxcui": ["312743", "312744", "312745", "317174", "389201", "616483", "616487"], "spl_set_id": ["8df82f5a-aa0e-4f8c-bae1-2f32ede3d7b6"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (65862-495-01)", "package_ndc": "65862-495-01", "marketing_start_date": "20120327"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (65862-495-05)", "package_ndc": "65862-495-05", "marketing_start_date": "20120327"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (65862-495-10)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "65862-495-10", "marketing_start_date": "20120327"}], "brand_name": "Quetiapine Fumarate", "product_id": "65862-495_f759dcc0-2e6c-4743-8772-3f05602db2a3", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "65862-495", "generic_name": "Quetiapine Fumarate", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine Fumarate", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "400 mg/1"}], "application_number": "ANDA091388", "marketing_category": "ANDA", "marketing_start_date": "20120327", "listing_expiration_date": "20261231"}