quetiapine

Generic: quetiapine

Labeler: cardinal health 107, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name quetiapine
Generic Name quetiapine
Labeler cardinal health 107, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

quetiapine fumarate 50 mg/1

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-8092
Product ID 55154-8092_4168e0ed-ac82-4e1b-9ed9-b0680acd55a0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201504
Listing Expiration 2027-12-31
Marketing Start 2013-03-01

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 551548092
Hyphenated Format 55154-8092

Supplemental Identifiers

RxCUI
312743 312744 317174 616487
UPC
0055154809207 0055154335904
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 (source: ndc)
Generic Name quetiapine (source: ndc)
Application Number ANDA201504 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 BAG (55154-8092-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

55154-8092-0 10 BLISTER PACK in 1 BAG (55154-8092-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

quetiapine fumarate (50 mg/1)

Linked Drug Pages (1)

Quetiapine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4168e0ed-ac82-4e1b-9ed9-b0680acd55a0", "openfda": {"upc": ["0055154809207", "0055154335904"], "unii": ["2S3PL1B6UJ"], "rxcui": ["312743", "312744", "317174", "616487"], "spl_set_id": ["32bc1ecb-7285-4013-b266-ca783a62d617"], "manufacturer_name": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 BAG (55154-8092-0)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "55154-8092-0", "marketing_start_date": "20130301"}], "brand_name": "Quetiapine", "product_id": "55154-8092_4168e0ed-ac82-4e1b-9ed9-b0680acd55a0", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "55154-8092", "generic_name": "Quetiapine", "labeler_name": "Cardinal Health 107, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "50 mg/1"}], "application_number": "ANDA201504", "marketing_category": "ANDA", "marketing_start_date": "20130301", "listing_expiration_date": "20271231"}