quetiapine extended release

Generic: quetiapine

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

Drug Facts

Product Profile

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

quetiapine fumarate 150 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4051
Product ID 70518-4051_3fa1b7c9-0ddc-66f7-e063-6294a90a9b6b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209635
Listing Expiration 2026-12-31
Marketing Start 2024-04-13

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705184051
Hyphenated Format 70518-4051

Supplemental Identifiers

RxCUI
895670
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 extended release (source: ndc)
Generic Name quetiapine (source: ndc)
Application Number ANDA209635 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70518-4051-0)
source: ndc

Packages (1)

70518-4051-0 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70518-4051-0)

Ingredients (1)

quetiapine fumarate (150 mg/1)

Linked Drug Pages (1)

Quetiapine Extended Release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3fa1b7c9-0ddc-66f7-e063-6294a90a9b6b", "openfda": {"unii": ["2S3PL1B6UJ"], "rxcui": ["895670"], "spl_set_id": ["995731f7-aace-4140-b699-d6e8975c7c83"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70518-4051-0)", "package_ndc": "70518-4051-0", "marketing_start_date": "20240413"}], "brand_name": "Quetiapine Extended Release", "product_id": "70518-4051_3fa1b7c9-0ddc-66f7-e063-6294a90a9b6b", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "70518-4051", "generic_name": "Quetiapine", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine", "brand_name_suffix": "Extended Release", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "150 mg/1"}], "application_number": "ANDA209635", "marketing_category": "ANDA", "marketing_start_date": "20240413", "listing_expiration_date": "20261231"}