quetiapine fumarate

Generic: quetiapine fumarate

Labeler: quallent pharmaceuticals health llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name quetiapine fumarate
Generic Name quetiapine fumarate
Labeler quallent pharmaceuticals health llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

quetiapine fumarate 100 mg/1

Manufacturer
Quallent Pharmaceuticals Health LLC

Identifiers & Regulatory

Product NDC 82009-097
Product ID 82009-097_c967a20e-cf1b-4bda-a63f-22ccdccef6aa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201109
Listing Expiration 2026-12-31
Marketing Start 2023-07-14

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82009097
Hyphenated Format 82009-097

Supplemental Identifiers

RxCUI
312743 312744 317174 616487
UPC
0382009097107 0382009096100
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 ANDA201109 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (82009-097-10)
source: ndc

Packages (1)

82009-097-10 1000 TABLET in 1 BOTTLE (82009-097-10)

Ingredients (1)

quetiapine fumarate (100 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": "c967a20e-cf1b-4bda-a63f-22ccdccef6aa", "openfda": {"upc": ["0382009097107", "0382009096100"], "unii": ["2S3PL1B6UJ"], "rxcui": ["312743", "312744", "317174", "616487"], "spl_set_id": ["d51c5bf6-950d-493b-be55-de575c5ef2e7"], "manufacturer_name": ["Quallent Pharmaceuticals Health LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (82009-097-10)", "package_ndc": "82009-097-10", "marketing_start_date": "20230714"}], "brand_name": "Quetiapine fumarate", "product_id": "82009-097_c967a20e-cf1b-4bda-a63f-22ccdccef6aa", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "82009-097", "generic_name": "quetiapine fumarate", "labeler_name": "Quallent Pharmaceuticals Health LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine fumarate", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "100 mg/1"}], "application_number": "ANDA201109", "marketing_category": "ANDA", "marketing_start_date": "20230714", "listing_expiration_date": "20261231"}