quetiapine fumarate

Generic: quetiapine fumarate

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name quetiapine fumarate
Generic Name quetiapine fumarate
Labeler lupin pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

quetiapine fumarate 50 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-446
Product ID 68180-446_a644051f-21f4-4c76-9ed2-e96417d77df9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201109
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 68180446
Hyphenated Format 68180-446

Supplemental Identifiers

RxCUI
312743 312744 312745 317174 616483 616487
UPC
0368180448013 0368180450016 0368180445012
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
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68180-446-01)
  • 1000 TABLET in 1 BOTTLE (68180-446-03)
source: ndc

Packages (2)

68180-446-01 100 TABLET in 1 BOTTLE (68180-446-01) 68180-446-03 1000 TABLET in 1 BOTTLE (68180-446-03)

Ingredients (1)

quetiapine fumarate (50 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": "a644051f-21f4-4c76-9ed2-e96417d77df9", "openfda": {"upc": ["0368180448013", "0368180450016", "0368180445012"], "unii": ["2S3PL1B6UJ"], "rxcui": ["312743", "312744", "312745", "317174", "616483", "616487"], "spl_set_id": ["a951cd63-d329-47c9-965a-582fa73a07c6"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68180-446-01)", "package_ndc": "68180-446-01", "marketing_start_date": "20120327"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (68180-446-03)", "package_ndc": "68180-446-03", "marketing_start_date": "20120327"}], "brand_name": "Quetiapine fumarate", "product_id": "68180-446_a644051f-21f4-4c76-9ed2-e96417d77df9", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "68180-446", "generic_name": "quetiapine fumarate", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine fumarate", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "50 mg/1"}], "application_number": "ANDA201109", "marketing_category": "ANDA", "marketing_start_date": "20120327", "listing_expiration_date": "20261231"}