quetiapine

Generic: quetiapine

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

Drug Facts

Product Profile

Brand Name quetiapine
Generic Name quetiapine
Labeler remedyrepack inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

quetiapine fumarate 50 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4430
Product ID 70518-4430_3c2f4bb7-7928-4694-e063-6394a90a0578
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215478
Listing Expiration 2026-12-31
Marketing Start 2025-08-12

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705184430
Hyphenated Format 70518-4430

Supplemental Identifiers

RxCUI
853201
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 ANDA215478 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 60 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-4430-0)
  • 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-4430-1)
source: ndc

Packages (2)

70518-4430-0 60 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-4430-0) 70518-4430-1 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-4430-1)

Ingredients (1)

quetiapine fumarate (50 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": "3c2f4bb7-7928-4694-e063-6394a90a0578", "openfda": {"unii": ["2S3PL1B6UJ"], "rxcui": ["853201"], "spl_set_id": ["e3c2740c-a77a-428d-a99b-f78d8e530acd"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-4430-0)", "package_ndc": "70518-4430-0", "marketing_start_date": "20250812"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-4430-1)", "package_ndc": "70518-4430-1", "marketing_start_date": "20250812"}], "brand_name": "Quetiapine", "product_id": "70518-4430_3c2f4bb7-7928-4694-e063-6394a90a0578", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "70518-4430", "generic_name": "Quetiapine", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "50 mg/1"}], "application_number": "ANDA215478", "marketing_category": "ANDA", "marketing_start_date": "20250812", "listing_expiration_date": "20261231"}