quetiapine

Generic: quetiapine

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

Drug Facts

Product Profile

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

quetiapine fumarate 100 mg/1

Manufacturer
ASCLEMED USA INC.

Identifiers & Regulatory

Product NDC 76420-514
Product ID 76420-514_41a41d6e-d9e9-4f2d-e063-6394a90aa6f5
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 76420514
Hyphenated Format 76420-514

Supplemental Identifiers

RxCUI
312743 312744 312745 317174 389201 616483 616487
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 ANDA201504 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (76420-514-01)
  • 10 TABLET, FILM COATED in 1 BOTTLE (76420-514-10)
  • 20 TABLET, FILM COATED in 1 BOTTLE (76420-514-20)
  • 30 TABLET, FILM COATED in 1 BOTTLE (76420-514-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (76420-514-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (76420-514-90)
source: ndc

Packages (6)

76420-514-01 100 TABLET, FILM COATED in 1 BOTTLE (76420-514-01) 76420-514-10 10 TABLET, FILM COATED in 1 BOTTLE (76420-514-10) 76420-514-20 20 TABLET, FILM COATED in 1 BOTTLE (76420-514-20) 76420-514-30 30 TABLET, FILM COATED in 1 BOTTLE (76420-514-30) 76420-514-60 60 TABLET, FILM COATED in 1 BOTTLE (76420-514-60) 76420-514-90 90 TABLET, FILM COATED in 1 BOTTLE (76420-514-90)

Ingredients (1)

quetiapine fumarate (100 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": "41a41d6e-d9e9-4f2d-e063-6394a90aa6f5", "openfda": {"unii": ["2S3PL1B6UJ"], "rxcui": ["312743", "312744", "312745", "317174", "389201", "616483", "616487"], "spl_set_id": ["74e09734-26cb-42fe-b9a3-79cc10505e0b"], "manufacturer_name": ["ASCLEMED USA INC."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (76420-514-01)", "package_ndc": "76420-514-01", "marketing_start_date": "20251021"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (76420-514-10)", "package_ndc": "76420-514-10", "marketing_start_date": "20251021"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (76420-514-20)", "package_ndc": "76420-514-20", "marketing_start_date": "20251021"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (76420-514-30)", "package_ndc": "76420-514-30", "marketing_start_date": "20251021"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (76420-514-60)", "package_ndc": "76420-514-60", "marketing_start_date": "20251021"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (76420-514-90)", "package_ndc": "76420-514-90", "marketing_start_date": "20251021"}], "brand_name": "Quetiapine", "product_id": "76420-514_41a41d6e-d9e9-4f2d-e063-6394a90aa6f5", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "76420-514", "generic_name": "Quetiapine", "labeler_name": "ASCLEMED USA INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "100 mg/1"}], "application_number": "ANDA201504", "marketing_category": "ANDA", "marketing_start_date": "20130301", "listing_expiration_date": "20261231"}