quetiapine extended release

Generic: quetiapine

Labeler: nucare pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name quetiapine extended release
Generic Name quetiapine
Labeler nucare pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

quetiapine fumarate 50 mg/1

Manufacturer
NuCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68071-3921
Product ID 68071-3921_44e9af46-3b06-d8ac-e063-6394a90a6bbb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209635
Listing Expiration 2026-12-31
Marketing Start 2017-11-29

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680713921
Hyphenated Format 68071-3921

Supplemental Identifiers

RxCUI
853201
UPC
0368071392166
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 extended release (source: ndc)
Generic Name quetiapine (source: ndc)
Application Number ANDA209635 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68071-3921-6)
source: ndc

Packages (1)

68071-3921-6 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68071-3921-6)

Ingredients (1)

quetiapine fumarate (50 mg/1)

Linked Drug Pages (1)

Quetiapine Extended Release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "44e9af46-3b06-d8ac-e063-6394a90a6bbb", "openfda": {"upc": ["0368071392166"], "unii": ["2S3PL1B6UJ"], "rxcui": ["853201"], "spl_set_id": ["44e9b338-b163-bee7-e063-6394a90a1338"], "manufacturer_name": ["NuCare Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68071-3921-6)", "package_ndc": "68071-3921-6", "marketing_start_date": "20251201"}], "brand_name": "Quetiapine Extended Release", "product_id": "68071-3921_44e9af46-3b06-d8ac-e063-6394a90a6bbb", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "68071-3921", "generic_name": "Quetiapine", "labeler_name": "NuCare Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine", "brand_name_suffix": "Extended Release", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "50 mg/1"}], "application_number": "ANDA209635", "marketing_category": "ANDA", "marketing_start_date": "20171129", "listing_expiration_date": "20261231"}