quetiapine

Generic: quetiapine

Labeler: solco healthcare u.s., llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name quetiapine
Generic Name quetiapine
Labeler solco healthcare u.s., llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

quetiapine 300 mg/1

Manufacturer
Solco Healthcare U.S., LLC

Identifiers & Regulatory

Product NDC 43547-022
Product ID 43547-022_058aac79-3e9f-46b2-a2f8-693ffb211aef
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208781
Listing Expiration 2026-12-31
Marketing Start 2022-04-01

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43547022
Hyphenated Format 43547-022

Supplemental Identifiers

RxCUI
721791 721794 721796 853201 895670
UNII
BGL0JSY5SI
NUI
N0000175430

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 ANDA208781 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (43547-022-06)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43547-022-50)
source: ndc

Packages (2)

43547-022-06 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (43547-022-06) 43547-022-50 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43547-022-50)

Ingredients (1)

quetiapine (300 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": "058aac79-3e9f-46b2-a2f8-693ffb211aef", "openfda": {"nui": ["N0000175430"], "unii": ["BGL0JSY5SI"], "rxcui": ["721791", "721794", "721796", "853201", "895670"], "spl_set_id": ["b0cce89c-0e84-4f60-8e50-0e26c41c2613"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Solco Healthcare U.S., LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (43547-022-06)", "package_ndc": "43547-022-06", "marketing_start_date": "20220401"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43547-022-50)", "package_ndc": "43547-022-50", "marketing_start_date": "20220401"}], "brand_name": "QUETIAPINE", "product_id": "43547-022_058aac79-3e9f-46b2-a2f8-693ffb211aef", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "43547-022", "generic_name": "quetiapine", "labeler_name": "Solco Healthcare U.S., LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "QUETIAPINE", "active_ingredients": [{"name": "QUETIAPINE", "strength": "300 mg/1"}], "application_number": "ANDA208781", "marketing_category": "ANDA", "marketing_start_date": "20220401", "listing_expiration_date": "20261231"}