quetiapine fumarate

Generic: quetiapine fumarate

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name quetiapine fumarate
Generic Name quetiapine fumarate
Labeler remedyrepack inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

quetiapine fumarate 200 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3581
Product ID 70518-3581_3bdf3039-84ae-f728-e063-6394a90aa344
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091388
Listing Expiration 2026-12-31
Marketing Start 2022-11-19

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705183581
Hyphenated Format 70518-3581

Supplemental Identifiers

RxCUI
317174
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 ANDA091388 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3581-0)
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3581-1)
source: ndc

Packages (2)

70518-3581-0 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3581-0) 70518-3581-1 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3581-1)

Ingredients (1)

quetiapine fumarate (200 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": "3bdf3039-84ae-f728-e063-6394a90aa344", "openfda": {"unii": ["2S3PL1B6UJ"], "rxcui": ["317174"], "spl_set_id": ["911bf26c-a89a-4ce1-8ff5-cfda03d0a482"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3581-0)", "package_ndc": "70518-3581-0", "marketing_start_date": "20221119"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3581-1)", "package_ndc": "70518-3581-1", "marketing_start_date": "20240627"}], "brand_name": "Quetiapine Fumarate", "product_id": "70518-3581_3bdf3039-84ae-f728-e063-6394a90aa344", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "70518-3581", "generic_name": "Quetiapine Fumarate", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine Fumarate", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "200 mg/1"}], "application_number": "ANDA091388", "marketing_category": "ANDA", "marketing_start_date": "20221119", "listing_expiration_date": "20261231"}