quetiapine

Generic: quetiapine

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name quetiapine
Generic Name quetiapine
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

quetiapine fumarate 50 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-266
Product ID 72789-266_31b9bfe1-9c84-b590-e063-6294a90a482c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201504
Listing Expiration 2026-12-31
Marketing Start 2013-03-01

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72789266
Hyphenated Format 72789-266

Supplemental Identifiers

RxCUI
616487
UPC
0372789266077
UNII
2S3PL1B6UJ

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 ANDA201504 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-266-07)
source: ndc

Packages (1)

72789-266-07 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-266-07)

Ingredients (1)

quetiapine fumarate (50 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": "31b9bfe1-9c84-b590-e063-6294a90a482c", "openfda": {"upc": ["0372789266077"], "unii": ["2S3PL1B6UJ"], "rxcui": ["616487"], "spl_set_id": ["da3c9642-9f8d-422b-8e12-2036d68f78ca"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-266-07)", "package_ndc": "72789-266-07", "marketing_start_date": "20220816"}], "brand_name": "Quetiapine", "product_id": "72789-266_31b9bfe1-9c84-b590-e063-6294a90a482c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "72789-266", "generic_name": "Quetiapine", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "50 mg/1"}], "application_number": "ANDA201504", "marketing_category": "ANDA", "marketing_start_date": "20130301", "listing_expiration_date": "20261231"}