quetiapine fumarate

Generic: quetiapine fumarate

Labeler: golden state medical supply, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name quetiapine fumarate
Generic Name quetiapine fumarate
Labeler golden state medical supply, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

quetiapine fumarate 50 mg/1

Manufacturer
Golden State Medical Supply, Inc.

Identifiers & Regulatory

Product NDC 51407-067
Product ID 51407-067_31e6a4fb-7f18-d5a4-e063-6394a90acfb3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090749
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 51407067
Hyphenated Format 51407-067

Supplemental Identifiers

RxCUI
312743 312744 312745 317174 616483 616487
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 ANDA090749 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (51407-067-01)
  • 1000 TABLET in 1 BOTTLE (51407-067-10)
source: ndc

Packages (2)

51407-067-01 100 TABLET in 1 BOTTLE (51407-067-01) 51407-067-10 1000 TABLET in 1 BOTTLE (51407-067-10)

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": "31e6a4fb-7f18-d5a4-e063-6394a90acfb3", "openfda": {"unii": ["2S3PL1B6UJ"], "rxcui": ["312743", "312744", "312745", "317174", "616483", "616487"], "spl_set_id": ["6fc9c8e2-6f34-aa43-e053-2a91aa0ac377"], "manufacturer_name": ["Golden State Medical Supply, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (51407-067-01)", "package_ndc": "51407-067-01", "marketing_start_date": "20180316"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (51407-067-10)", "package_ndc": "51407-067-10", "marketing_start_date": "20180316"}], "brand_name": "Quetiapine Fumarate", "product_id": "51407-067_31e6a4fb-7f18-d5a4-e063-6394a90acfb3", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "51407-067", "generic_name": "Quetiapine Fumarate", "labeler_name": "Golden State Medical Supply, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine Fumarate", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "50 mg/1"}], "application_number": "ANDA090749", "marketing_category": "ANDA", "marketing_start_date": "20120327", "listing_expiration_date": "20261231"}