quetiapine extended-release

Generic: quetiapine

Labeler: alignscience pharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

quetiapine fumarate 200 mg/1

Manufacturer
AlignScience Pharma Inc.

Identifiers & Regulatory

Product NDC 69948-003
Product ID 69948-003_47232802-9e04-c181-e063-6394a90a9d90
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209497
Listing Expiration 2026-12-31
Marketing Start 2020-12-31

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69948003
Hyphenated Format 69948-003

Supplemental Identifiers

RxCUI
721791 895670
UPC
0369948002034 0369948003031 0369948003116 0369948002119
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 ANDA209497 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69948-003-03)
  • 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69948-003-11)
source: ndc

Packages (2)

69948-003-03 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69948-003-03) 69948-003-11 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69948-003-11)

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": "47232802-9e04-c181-e063-6394a90a9d90", "openfda": {"upc": ["0369948002034", "0369948003031", "0369948003116", "0369948002119"], "unii": ["2S3PL1B6UJ"], "rxcui": ["721791", "895670"], "spl_set_id": ["db3ba268-21a2-4988-b5c1-353741bcaee5"], "manufacturer_name": ["AlignScience Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69948-003-03)", "package_ndc": "69948-003-03", "marketing_start_date": "20201231"}, {"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69948-003-11)", "package_ndc": "69948-003-11", "marketing_start_date": "20251229"}], "brand_name": "Quetiapine Extended-Release", "product_id": "69948-003_47232802-9e04-c181-e063-6394a90a9d90", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "69948-003", "generic_name": "Quetiapine", "labeler_name": "AlignScience Pharma 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": "ANDA209497", "marketing_category": "ANDA", "marketing_start_date": "20201231", "listing_expiration_date": "20261231"}