quetiapine fumarate

Generic: quetiapine fumarate

Labeler: st. mary's medical park pharmacy
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name quetiapine fumarate
Generic Name quetiapine fumarate
Labeler st. mary's medical park pharmacy
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

quetiapine fumarate 25 mg/1

Manufacturer
ST. MARY'S MEDICAL PARK PHARMACY

Identifiers & Regulatory

Product NDC 60760-764
Product ID 60760-764_3624c9e6-3300-a325-e063-6394a90ae610
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204316
Listing Expiration 2026-12-31
Marketing Start 2022-06-16

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60760764
Hyphenated Format 60760-764

Supplemental Identifiers

RxCUI
312744
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 fumarate (source: ndc)
Generic Name quetiapine fumarate (source: ndc)
Application Number ANDA204316 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-764-30)
source: ndc

Packages (1)

60760-764-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-764-30)

Ingredients (1)

quetiapine fumarate (25 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": "3624c9e6-3300-a325-e063-6394a90ae610", "openfda": {"unii": ["2S3PL1B6UJ"], "rxcui": ["312744"], "spl_set_id": ["3624c430-2a17-a83a-e063-6394a90add93"], "manufacturer_name": ["ST. MARY'S MEDICAL PARK PHARMACY"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-764-30)", "package_ndc": "60760-764-30", "marketing_start_date": "20250521"}], "brand_name": "Quetiapine Fumarate", "product_id": "60760-764_3624c9e6-3300-a325-e063-6394a90ae610", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "60760-764", "generic_name": "Quetiapine Fumarate", "labeler_name": "ST. MARY'S MEDICAL PARK PHARMACY", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine Fumarate", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "25 mg/1"}], "application_number": "ANDA204316", "marketing_category": "ANDA", "marketing_start_date": "20220616", "listing_expiration_date": "20261231"}