quetiapine fumarate

Generic: quetiapine fumarate

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name quetiapine fumarate
Generic Name quetiapine fumarate
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

quetiapine fumarate 300 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-127
Product ID 71610-127_2ddf4cb0-6d16-49fa-9267-274ed1643e90
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090749
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 71610127
Hyphenated Format 71610-127

Supplemental Identifiers

RxCUI
312743 312744 312745 317174 616483
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 fumarate (source: ndc)
Generic Name quetiapine fumarate (source: ndc)
Application Number ANDA090749 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 3000 TABLET in 1 BOTTLE (71610-127-18)
source: ndc

Packages (1)

71610-127-18 3000 TABLET in 1 BOTTLE (71610-127-18)

Ingredients (1)

quetiapine fumarate (300 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": "2ddf4cb0-6d16-49fa-9267-274ed1643e90", "openfda": {"unii": ["2S3PL1B6UJ"], "rxcui": ["312743", "312744", "312745", "317174", "616483"], "spl_set_id": ["60316ccd-c042-4ea0-9d05-3caf7cc2cab1"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "3000 TABLET in 1 BOTTLE (71610-127-18)", "package_ndc": "71610-127-18", "marketing_start_date": "20180829"}], "brand_name": "Quetiapine Fumarate", "product_id": "71610-127_2ddf4cb0-6d16-49fa-9267-274ed1643e90", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "71610-127", "generic_name": "Quetiapine Fumarate", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine Fumarate", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "300 mg/1"}], "application_number": "ANDA090749", "marketing_category": "ANDA", "marketing_start_date": "20120327", "listing_expiration_date": "20261231"}