quetiapine fumarate

Generic: quetiapine fumarate

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name quetiapine fumarate
Generic Name quetiapine fumarate
Labeler proficient rx lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

quetiapine fumarate 400 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-031
Product ID 71205-031_013ee364-8c04-4e34-9787-834504e94c72
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 71205031
Hyphenated Format 71205-031

Supplemental Identifiers

RxCUI
616483
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 fumarate (source: ndc)
Generic Name quetiapine fumarate (source: ndc)
Application Number ANDA201504 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (71205-031-30)
  • 60 TABLET in 1 BOTTLE (71205-031-60)
  • 90 TABLET in 1 BOTTLE (71205-031-90)
source: ndc

Packages (3)

71205-031-30 30 TABLET in 1 BOTTLE (71205-031-30) 71205-031-60 60 TABLET in 1 BOTTLE (71205-031-60) 71205-031-90 90 TABLET in 1 BOTTLE (71205-031-90)

Ingredients (1)

quetiapine fumarate (400 mg/1)

Linked Drug Pages (1)

Quetiapine Fumarate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "013ee364-8c04-4e34-9787-834504e94c72", "openfda": {"unii": ["2S3PL1B6UJ"], "rxcui": ["616483"], "spl_set_id": ["03517f29-f270-4350-a57a-fbe1967b0096"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (71205-031-30)", "package_ndc": "71205-031-30", "marketing_start_date": "20180501"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71205-031-60)", "package_ndc": "71205-031-60", "marketing_start_date": "20180501"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71205-031-90)", "package_ndc": "71205-031-90", "marketing_start_date": "20180501"}], "brand_name": "Quetiapine Fumarate", "product_id": "71205-031_013ee364-8c04-4e34-9787-834504e94c72", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "71205-031", "generic_name": "Quetiapine Fumarate", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine Fumarate", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "400 mg/1"}], "application_number": "ANDA201504", "marketing_category": "ANDA", "marketing_start_date": "20130301", "listing_expiration_date": "20261231"}