quetiapine

Generic: quetiapine

Labeler: solco healthcare us, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name quetiapine
Generic Name quetiapine
Labeler solco healthcare us, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

quetiapine fumarate 50 mg/1

Manufacturer
Solco Healthcare US, LLC

Identifiers & Regulatory

Product NDC 43547-519
Product ID 43547-519_c91f8a6b-86e3-40a5-befe-4617aa36c718
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206954
Listing Expiration 2026-12-31
Marketing Start 2022-04-12

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43547519
Hyphenated Format 43547-519

Supplemental Identifiers

RxCUI
312743 312744 312745 317174 616483 616487
UPC
0343547519100 0343547520106 0343547518103 0343547523107 0343547522063 0343547521103
UNII
2S3PL1B6UJ

Packaging Origin

Original Packager
true

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 ANDA206954 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (43547-519-10)
  • 1000 TABLET in 1 BOTTLE (43547-519-11)
source: ndc

Packages (2)

43547-519-10 100 TABLET in 1 BOTTLE (43547-519-10) 43547-519-11 1000 TABLET in 1 BOTTLE (43547-519-11)

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": "c91f8a6b-86e3-40a5-befe-4617aa36c718", "openfda": {"upc": ["0343547519100", "0343547520106", "0343547518103", "0343547523107", "0343547522063", "0343547521103"], "unii": ["2S3PL1B6UJ"], "rxcui": ["312743", "312744", "312745", "317174", "616483", "616487"], "spl_set_id": ["61b1230e-c0dc-46c6-a577-7d5dd2515eb7"], "manufacturer_name": ["Solco Healthcare US, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (43547-519-10)", "package_ndc": "43547-519-10", "marketing_start_date": "20220412"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (43547-519-11)", "package_ndc": "43547-519-11", "marketing_start_date": "20220412"}], "brand_name": "QUETIAPINE", "product_id": "43547-519_c91f8a6b-86e3-40a5-befe-4617aa36c718", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "43547-519", "generic_name": "quetiapine", "labeler_name": "Solco Healthcare US, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "QUETIAPINE", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "50 mg/1"}], "application_number": "ANDA206954", "marketing_category": "ANDA", "marketing_start_date": "20220412", "listing_expiration_date": "20261231"}