arsenic trioxide

Generic: arsenic trioxide

Labeler: sintetica us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name arsenic trioxide
Generic Name arsenic trioxide
Labeler sintetica us llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

arsenic trioxide 2 mg/mL

Manufacturer
Sintetica US LLC

Identifiers & Regulatory

Product NDC 83090-010
Product ID 83090-010_d95da146-99a2-491f-be7e-28e5fd86928f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217413
Listing Expiration 2026-12-31
Marketing Start 2023-11-09

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83090010
Hyphenated Format 83090-010

Supplemental Identifiers

RxCUI
829926 1992545
UNII
S7V92P67HO

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 arsenic trioxide (source: ndc)
Generic Name arsenic trioxide (source: ndc)
Application Number ANDA217413 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (83090-010-01) / 6 mL in 1 VIAL, SINGLE-DOSE (83090-010-05)
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (83090-010-10) / 6 mL in 1 VIAL, SINGLE-DOSE (83090-010-05)
source: ndc

Packages (2)

83090-010-01 1 VIAL, SINGLE-DOSE in 1 CARTON (83090-010-01) / 6 mL in 1 VIAL, SINGLE-DOSE (83090-010-05) 83090-010-10 10 VIAL, SINGLE-DOSE in 1 CARTON (83090-010-10) / 6 mL in 1 VIAL, SINGLE-DOSE (83090-010-05)

Ingredients (1)

arsenic trioxide (2 mg/mL)

Linked Drug Pages (1)

ARSENIC TRIOXIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "d95da146-99a2-491f-be7e-28e5fd86928f", "openfda": {"unii": ["S7V92P67HO"], "rxcui": ["829926", "1992545"], "spl_set_id": ["d921f52f-2f38-4300-ae40-31f00b3a500a"], "manufacturer_name": ["Sintetica US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (83090-010-01)  / 6 mL in 1 VIAL, SINGLE-DOSE (83090-010-05)", "package_ndc": "83090-010-01", "marketing_start_date": "20231109"}, {"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (83090-010-10)  / 6 mL in 1 VIAL, SINGLE-DOSE (83090-010-05)", "package_ndc": "83090-010-10", "marketing_start_date": "20231109"}], "brand_name": "ARSENIC TRIOXIDE", "product_id": "83090-010_d95da146-99a2-491f-be7e-28e5fd86928f", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "83090-010", "generic_name": "arsenic trioxide", "labeler_name": "Sintetica US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ARSENIC TRIOXIDE", "active_ingredients": [{"name": "ARSENIC TRIOXIDE", "strength": "2 mg/mL"}], "application_number": "ANDA217413", "marketing_category": "ANDA", "marketing_start_date": "20231109", "listing_expiration_date": "20261231"}