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 50 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-788
Product ID 71205-788_c1f2ccba-62f3-44e7-b06f-dea61eac9e93
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 71205788
Hyphenated Format 71205-788

Supplemental Identifiers

RxCUI
616487
UPC
0371205788308
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
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (71205-788-30)
  • 60 TABLET in 1 BOTTLE (71205-788-60)
  • 90 TABLET in 1 BOTTLE (71205-788-90)
source: ndc

Packages (3)

71205-788-30 30 TABLET in 1 BOTTLE (71205-788-30) 71205-788-60 60 TABLET in 1 BOTTLE (71205-788-60) 71205-788-90 90 TABLET in 1 BOTTLE (71205-788-90)

Ingredients (1)

quetiapine fumarate (50 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": "c1f2ccba-62f3-44e7-b06f-dea61eac9e93", "openfda": {"upc": ["0371205788308"], "unii": ["2S3PL1B6UJ"], "rxcui": ["616487"], "spl_set_id": ["c1f2ccba-62f3-44e7-b06f-dea61eac9e93"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (71205-788-30)", "package_ndc": "71205-788-30", "marketing_start_date": "20230406"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71205-788-60)", "package_ndc": "71205-788-60", "marketing_start_date": "20230406"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71205-788-90)", "package_ndc": "71205-788-90", "marketing_start_date": "20230406"}], "brand_name": "Quetiapine Fumarate", "product_id": "71205-788_c1f2ccba-62f3-44e7-b06f-dea61eac9e93", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "71205-788", "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": "50 mg/1"}], "application_number": "ANDA201504", "marketing_category": "ANDA", "marketing_start_date": "20130301", "listing_expiration_date": "20261231"}