quetiapine

Generic: quetiapine

Labeler: accord healthcare inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name quetiapine
Generic Name quetiapine
Labeler accord healthcare inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

quetiapine fumarate 200 mg/1

Manufacturer
Accord Healthcare Inc.

Identifiers & Regulatory

Product NDC 16729-148
Product ID 16729-148_438f950d-730b-8926-e063-6294a90a8f66
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202152
Listing Expiration 2026-12-31
Marketing Start 2012-03-28

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16729148
Hyphenated Format 16729-148

Supplemental Identifiers

RxCUI
312743 312744 312745 317174 616483 616487
UPC
0316729150101 0316729147101 0316729146104 0316729145107 0316729148108
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 (source: ndc)
Generic Name quetiapine (source: ndc)
Application Number ANDA202152 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (16729-148-01)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (16729-148-17)
source: ndc

Packages (2)

16729-148-01 100 TABLET, FILM COATED in 1 BOTTLE (16729-148-01) 16729-148-17 1000 TABLET, FILM COATED in 1 BOTTLE (16729-148-17)

Ingredients (1)

quetiapine fumarate (200 mg/1)

Linked Drug Pages (1)

Quetiapine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "438f950d-730b-8926-e063-6294a90a8f66", "openfda": {"upc": ["0316729150101", "0316729147101", "0316729146104", "0316729145107", "0316729148108"], "unii": ["2S3PL1B6UJ"], "rxcui": ["312743", "312744", "312745", "317174", "616483", "616487"], "spl_set_id": ["2d77412a-e084-4406-ac33-d882aece9354"], "manufacturer_name": ["Accord Healthcare Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (16729-148-01)", "package_ndc": "16729-148-01", "marketing_start_date": "20150721"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (16729-148-17)", "package_ndc": "16729-148-17", "marketing_start_date": "20120328"}], "brand_name": "Quetiapine", "product_id": "16729-148_438f950d-730b-8926-e063-6294a90a8f66", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "16729-148", "generic_name": "Quetiapine", "labeler_name": "Accord Healthcare Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "200 mg/1"}], "application_number": "ANDA202152", "marketing_category": "ANDA", "marketing_start_date": "20120328", "listing_expiration_date": "20261231"}