quetiapine

Generic: quetiapine

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name quetiapine
Generic Name quetiapine
Labeler major pharmaceuticals
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

quetiapine fumarate 25 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6638
Product ID 0904-6638_50f28d31-26e7-46fb-8bcb-207554f50708
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201504
Listing Expiration 2027-12-31
Marketing Start 2013-03-01

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09046638
Hyphenated Format 0904-6638

Supplemental Identifiers

RxCUI
312743 312744 312745 317174 616483 616487
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
  • 25 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-6638-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

0904-6638-61 100 BLISTER PACK in 1 CARTON (0904-6638-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

quetiapine fumarate (25 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": "50f28d31-26e7-46fb-8bcb-207554f50708", "openfda": {"unii": ["2S3PL1B6UJ"], "rxcui": ["312743", "312744", "312745", "317174", "616483", "616487"], "spl_set_id": ["f9447739-9e21-4232-950f-174c0496ab66"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-6638-61)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-6638-61", "marketing_start_date": "20130301"}], "brand_name": "Quetiapine", "product_id": "0904-6638_50f28d31-26e7-46fb-8bcb-207554f50708", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "0904-6638", "generic_name": "Quetiapine", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "25 mg/1"}], "application_number": "ANDA201504", "marketing_category": "ANDA", "marketing_start_date": "20130301", "listing_expiration_date": "20271231"}