quetiapine fumarate

Generic: quetiapine

Labeler: bluepoint laboratories
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

quetiapine fumarate 400 mg/1

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-181
Product ID 68001-181_36315be0-1fa7-8c8b-e063-6294a90afdd1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201109
Listing Expiration 2026-12-31
Marketing Start 2013-02-28

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68001181
Hyphenated Format 68001-181

Supplemental Identifiers

RxCUI
312743 312744 312745 317174 616483 616487
UPC
0368001184007 0368001185004 0368001182003 0368001181006 0368001180009 0368001183062
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 (source: ndc)
Application Number ANDA201109 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68001-181-00)
  • 500 TABLET in 1 BOTTLE (68001-181-03)
source: ndc

Packages (2)

68001-181-00 100 TABLET in 1 BOTTLE (68001-181-00) 68001-181-03 500 TABLET in 1 BOTTLE (68001-181-03)

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": "36315be0-1fa7-8c8b-e063-6294a90afdd1", "openfda": {"upc": ["0368001184007", "0368001185004", "0368001182003", "0368001181006", "0368001180009", "0368001183062"], "unii": ["2S3PL1B6UJ"], "rxcui": ["312743", "312744", "312745", "317174", "616483", "616487"], "spl_set_id": ["874e50ad-5da0-4ac3-9290-79442c91399e"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68001-181-00)", "package_ndc": "68001-181-00", "marketing_start_date": "20130228"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (68001-181-03)", "package_ndc": "68001-181-03", "marketing_start_date": "20130228"}], "brand_name": "Quetiapine fumarate", "product_id": "68001-181_36315be0-1fa7-8c8b-e063-6294a90afdd1", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "68001-181", "generic_name": "quetiapine", "labeler_name": "BluePoint Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine fumarate", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "400 mg/1"}], "application_number": "ANDA201109", "marketing_category": "ANDA", "marketing_start_date": "20130228", "listing_expiration_date": "20261231"}