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
Routes
ORAL
Active Ingredients

quetiapine fumarate 300 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-2113
Product ID 70518-2113_2f8a6c7b-1e01-eaaa-e063-6294a90a988d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201504
Listing Expiration 2026-12-31
Marketing Start 2019-05-23

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705182113
Hyphenated Format 70518-2113

Supplemental Identifiers

RxCUI
312745
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
  • 300 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (70518-2113-0)
source: ndc

Packages (1)

70518-2113-0 30 TABLET in 1 BLISTER PACK (70518-2113-0)

Ingredients (1)

quetiapine fumarate (300 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": "2f8a6c7b-1e01-eaaa-e063-6294a90a988d", "openfda": {"unii": ["2S3PL1B6UJ"], "rxcui": ["312745"], "spl_set_id": ["a98cbbbd-e8da-4d0b-b6b1-56de0e1ba338"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (70518-2113-0)", "package_ndc": "70518-2113-0", "marketing_start_date": "20190523"}], "brand_name": "Quetiapine Fumarate", "product_id": "70518-2113_2f8a6c7b-1e01-eaaa-e063-6294a90a988d", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "70518-2113", "generic_name": "Quetiapine Fumarate", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine Fumarate", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "300 mg/1"}], "application_number": "ANDA201504", "marketing_category": "ANDA", "marketing_start_date": "20190523", "listing_expiration_date": "20261231"}