quetiapine fumarate

Generic: quetiapine fumarate

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name quetiapine fumarate
Generic Name quetiapine fumarate
Labeler northstar rx llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

quetiapine fumarate 100 mg/1

Manufacturer
NorthStar Rx LLC

Identifiers & Regulatory

Product NDC 16714-377
Product ID 16714-377_f9701296-20d0-45e9-ae86-bafb9d7e7c04
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091388
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 16714377
Hyphenated Format 16714-377

Supplemental Identifiers

RxCUI
312743 312744 312745 317174 616483 616487
UPC
0316714377018 0316714375014 0316714376011
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 ANDA091388 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (16714-377-01)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (16714-377-02)
source: ndc

Packages (2)

16714-377-01 100 TABLET, FILM COATED in 1 BOTTLE (16714-377-01) 16714-377-02 1000 TABLET, FILM COATED in 1 BOTTLE (16714-377-02)

Ingredients (1)

quetiapine fumarate (100 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": "f9701296-20d0-45e9-ae86-bafb9d7e7c04", "openfda": {"upc": ["0316714377018", "0316714375014", "0316714376011"], "unii": ["2S3PL1B6UJ"], "rxcui": ["312743", "312744", "312745", "317174", "616483", "616487"], "spl_set_id": ["e6e25ef9-2671-489e-8eca-58bedb4f59ab"], "manufacturer_name": ["NorthStar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (16714-377-01)", "package_ndc": "16714-377-01", "marketing_start_date": "20120327"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (16714-377-02)", "package_ndc": "16714-377-02", "marketing_start_date": "20120327"}], "brand_name": "Quetiapine Fumarate", "product_id": "16714-377_f9701296-20d0-45e9-ae86-bafb9d7e7c04", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "16714-377", "generic_name": "Quetiapine Fumarate", "labeler_name": "NorthStar Rx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine Fumarate", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "100 mg/1"}], "application_number": "ANDA091388", "marketing_category": "ANDA", "marketing_start_date": "20120327", "listing_expiration_date": "20261231"}