quetiapine fumarate

Generic: quetiapine fumarate

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name quetiapine fumarate
Generic Name quetiapine fumarate
Labeler rising pharma holdings, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

quetiapine fumarate 400 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-722
Product ID 16571-722_b7aef4ea-0c7d-496f-b567-613189147c7e
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 16571722
Hyphenated Format 16571-722

Supplemental Identifiers

RxCUI
312743 312744 312745 317174 389201 616483 616487
UPC
0316571719013 0316571717019 0316571718016
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
  • 400 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (16571-722-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (16571-722-50)
source: ndc

Packages (2)

16571-722-01 100 TABLET, FILM COATED in 1 BOTTLE (16571-722-01) 16571-722-50 500 TABLET, FILM COATED in 1 BOTTLE (16571-722-50)

Ingredients (1)

quetiapine fumarate (400 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": "b7aef4ea-0c7d-496f-b567-613189147c7e", "openfda": {"upc": ["0316571719013", "0316571717019", "0316571718016"], "unii": ["2S3PL1B6UJ"], "rxcui": ["312743", "312744", "312745", "317174", "389201", "616483", "616487"], "spl_set_id": ["532c8ace-4cf5-4a08-bae7-2af8c41ffa3d"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (16571-722-01)", "package_ndc": "16571-722-01", "marketing_start_date": "20120327"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (16571-722-50)", "package_ndc": "16571-722-50", "marketing_start_date": "20120327"}], "brand_name": "Quetiapine Fumarate", "product_id": "16571-722_b7aef4ea-0c7d-496f-b567-613189147c7e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "16571-722", "generic_name": "Quetiapine Fumarate", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine Fumarate", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "400 mg/1"}], "application_number": "ANDA091388", "marketing_category": "ANDA", "marketing_start_date": "20120327", "listing_expiration_date": "20261231"}