quetiapine fumarate

Generic: quetiapine fumarate

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name quetiapine fumarate
Generic Name quetiapine fumarate
Labeler avpak
Dosage Form TABLET
Routes
ORAL
Active Ingredients

quetiapine fumarate 200 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-633
Product ID 50268-633_4614f183-03ad-4459-e063-6294a90a391d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201504
Listing Expiration 2026-12-31
Marketing Start 2016-05-26

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268633
Hyphenated Format 50268-633

Supplemental Identifiers

RxCUI
312743 312744 312745 317174 616483 616487
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 ANDA201504 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-633-15) / 1 TABLET in 1 BLISTER PACK (50268-633-11)
source: ndc

Packages (1)

50268-633-15 50 BLISTER PACK in 1 BOX (50268-633-15) / 1 TABLET in 1 BLISTER PACK (50268-633-11)

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": "4614f183-03ad-4459-e063-6294a90a391d", "openfda": {"unii": ["2S3PL1B6UJ"], "rxcui": ["312743", "312744", "312745", "317174", "616483", "616487"], "spl_set_id": ["6b7d7d2f-a50b-8e21-2de4-ccc102016384"], "manufacturer_name": ["AvPAK"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-633-15)  / 1 TABLET in 1 BLISTER PACK (50268-633-11)", "package_ndc": "50268-633-15", "marketing_start_date": "20160526"}], "brand_name": "Quetiapine Fumarate", "product_id": "50268-633_4614f183-03ad-4459-e063-6294a90a391d", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "50268-633", "generic_name": "Quetiapine Fumarate", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine Fumarate", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "200 mg/1"}], "application_number": "ANDA201504", "marketing_category": "ANDA", "marketing_start_date": "20160526", "listing_expiration_date": "20261231"}