quetiapine extended release

Generic: quetiapine

Labeler: aci healthcare usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

quetiapine fumarate 400 mg/1

Manufacturer
ACI Healthcare USA, Inc.

Identifiers & Regulatory

Product NDC 71093-139
Product ID 71093-139_8a3515c7-6fc7-4150-a898-23443e4802fd
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 71093139
Hyphenated Format 71093-139

Supplemental Identifiers

RxCUI
721791 721794 721796 853201 895670
UPC
0371093135024 0371093137028 0371093136021 0371093138025
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 extended release (source: ndc)
Generic Name quetiapine (source: ndc)
Application Number ANDA209635 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71093-139-02)
source: ndc

Packages (1)

71093-139-02 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71093-139-02)

Ingredients (1)

quetiapine fumarate (400 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": "8a3515c7-6fc7-4150-a898-23443e4802fd", "openfda": {"upc": ["0371093135024", "0371093137028", "0371093136021", "0371093138025"], "unii": ["2S3PL1B6UJ"], "rxcui": ["721791", "721794", "721796", "853201", "895670"], "spl_set_id": ["07e4f3f4-42cb-4b22-bf8d-8c3279d26e97"], "manufacturer_name": ["ACI Healthcare USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71093-139-02)", "package_ndc": "71093-139-02", "marketing_start_date": "20180201"}], "brand_name": "Quetiapine Extended Release", "product_id": "71093-139_8a3515c7-6fc7-4150-a898-23443e4802fd", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "71093-139", "generic_name": "Quetiapine", "labeler_name": "ACI Healthcare USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine", "brand_name_suffix": "Extended Release", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "400 mg/1"}], "application_number": "ANDA209635", "marketing_category": "ANDA", "marketing_start_date": "20171129", "listing_expiration_date": "20261231"}