quetiapine

Generic: quetiapine

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name quetiapine
Generic Name quetiapine
Labeler avkare
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

quetiapine fumarate 25 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-695
Product ID 42291-695_4871de67-6df0-716d-e063-6394a90a2195
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077745
Marketing Start 2022-05-25
Marketing End 2026-06-30

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42291695
Hyphenated Format 42291-695

Supplemental Identifiers

RxCUI
312743 312744 312745 317174 616483 616487
UNII
2S3PL1B6UJ

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 (source: ndc)
Generic Name quetiapine (source: ndc)
Application Number ANDA077745 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 1000 TABLET, FILM COATED in 1 BOTTLE (42291-695-10)
source: ndc

Packages (1)

42291-695-10 1000 TABLET, FILM COATED in 1 BOTTLE (42291-695-10)

Ingredients (1)

quetiapine fumarate (25 mg/1)

Linked Drug Pages (1)

Quetiapine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4871de67-6df0-716d-e063-6394a90a2195", "openfda": {"unii": ["2S3PL1B6UJ"], "rxcui": ["312743", "312744", "312745", "317174", "616483", "616487"], "spl_set_id": ["8a3fc038-aad1-6404-6ead-a4a55127cf43"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (42291-695-10)", "package_ndc": "42291-695-10", "marketing_end_date": "20260630", "marketing_start_date": "20220525"}], "brand_name": "Quetiapine", "product_id": "42291-695_4871de67-6df0-716d-e063-6394a90a2195", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "42291-695", "generic_name": "Quetiapine", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "25 mg/1"}], "application_number": "ANDA077745", "marketing_category": "ANDA", "marketing_end_date": "20260630", "marketing_start_date": "20220525"}