quetiapine extended release

Generic: quetiapine

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

Drug Facts

Product Profile

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

quetiapine fumarate 200 mg/1

Manufacturer
ScieGen Pharmaceuticals, Inc

Identifiers & Regulatory

Product NDC 50228-382
Product ID 50228-382_47ce17ad-f0c0-8ce7-e063-6294a90a7520
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209635
Listing Expiration 2027-12-31
Marketing Start 2017-11-29

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50228382
Hyphenated Format 50228-382

Supplemental Identifiers

RxCUI
721791 721794 721796 853201 895670
UPC
0350228380607 0350228382601 0350228384605 0350228381604 0350228383608
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
  • 200 mg/1
source: ndc
Packaging
  • 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-382-10)
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-382-30)
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-382-60)
source: ndc

Packages (3)

50228-382-10 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-382-10) 50228-382-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-382-30) 50228-382-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-382-60)

Ingredients (1)

quetiapine fumarate (200 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": "47ce17ad-f0c0-8ce7-e063-6294a90a7520", "openfda": {"upc": ["0350228380607", "0350228382601", "0350228384605", "0350228381604", "0350228383608"], "unii": ["2S3PL1B6UJ"], "rxcui": ["721791", "721794", "721796", "853201", "895670"], "spl_set_id": ["5e4a84b1-fb8c-44d0-8213-51e43d71db69"], "manufacturer_name": ["ScieGen Pharmaceuticals, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-382-10)", "package_ndc": "50228-382-10", "marketing_start_date": "20171129"}, {"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-382-30)", "package_ndc": "50228-382-30", "marketing_start_date": "20171129"}, {"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-382-60)", "package_ndc": "50228-382-60", "marketing_start_date": "20171129"}], "brand_name": "Quetiapine Extended Release", "product_id": "50228-382_47ce17ad-f0c0-8ce7-e063-6294a90a7520", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "50228-382", "generic_name": "Quetiapine", "labeler_name": "ScieGen Pharmaceuticals, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine", "brand_name_suffix": "Extended Release", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "200 mg/1"}], "application_number": "ANDA209635", "marketing_category": "ANDA", "marketing_start_date": "20171129", "listing_expiration_date": "20271231"}