quetiapine

Generic: quetiapine

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

Drug Facts

Product Profile

Brand Name quetiapine
Generic Name quetiapine
Labeler teva pharmaceuticals usa, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

quetiapine fumarate 200 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-8163
Product ID 0093-8163_5059f747-d59d-460b-99bc-7b76b235c094
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077745
Listing Expiration 2027-12-31
Marketing Start 2012-03-27

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00938163
Hyphenated Format 0093-8163

Supplemental Identifiers

RxCUI
312743 312744 312745 317174 616483 616487
UPC
0300938163014 0300932063013 0300938162017 0300938164011 0300938166015
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 ANDA077745 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (0093-8163-01)
source: ndc

Packages (1)

0093-8163-01 100 TABLET, FILM COATED in 1 BOTTLE (0093-8163-01)

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": "5059f747-d59d-460b-99bc-7b76b235c094", "openfda": {"upc": ["0300938163014", "0300932063013", "0300938162017", "0300938164011", "0300938166015"], "unii": ["2S3PL1B6UJ"], "rxcui": ["312743", "312744", "312745", "317174", "616483", "616487"], "spl_set_id": ["c1d4ef59-bf58-44fe-9b46-1af42e2f7f8b"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (0093-8163-01)", "package_ndc": "0093-8163-01", "marketing_start_date": "20120327"}], "brand_name": "Quetiapine", "product_id": "0093-8163_5059f747-d59d-460b-99bc-7b76b235c094", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "0093-8163", "generic_name": "Quetiapine", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "200 mg/1"}], "application_number": "ANDA077745", "marketing_category": "ANDA", "marketing_start_date": "20120327", "listing_expiration_date": "20271231"}