arsenic trioxide

Generic: arsenic trioxide

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name arsenic trioxide
Generic Name arsenic trioxide
Labeler sandoz inc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

arsenic trioxide 2 mg/mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-3498
Product ID 0781-3498_601a01b0-da7f-4b9d-9f66-bc67371a1268
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215359
Listing Expiration 2026-12-31
Marketing Start 2022-05-19

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07813498
Hyphenated Format 0781-3498

Supplemental Identifiers

RxCUI
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 ANDA215359 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (0781-3498-94) / 6 mL in 1 VIAL
  • 10 VIAL in 1 CARTON (0781-3498-95) / 6 mL in 1 VIAL (0781-3498-06)
source: ndc

Packages (2)

0781-3498-94 1 VIAL in 1 CARTON (0781-3498-94) / 6 mL in 1 VIAL 0781-3498-95 10 VIAL in 1 CARTON (0781-3498-95) / 6 mL in 1 VIAL (0781-3498-06)

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": "601a01b0-da7f-4b9d-9f66-bc67371a1268", "openfda": {"unii": ["S7V92P67HO"], "rxcui": ["1992545"], "spl_set_id": ["a9008658-c2dd-49f4-b1c4-26e232c81957"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (0781-3498-94)  / 6 mL in 1 VIAL", "package_ndc": "0781-3498-94", "marketing_start_date": "20220519"}, {"sample": false, "description": "10 VIAL in 1 CARTON (0781-3498-95)  / 6 mL in 1 VIAL (0781-3498-06)", "package_ndc": "0781-3498-95", "marketing_start_date": "20220519"}], "brand_name": "Arsenic Trioxide", "product_id": "0781-3498_601a01b0-da7f-4b9d-9f66-bc67371a1268", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "0781-3498", "generic_name": "Arsenic Trioxide", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Arsenic Trioxide", "active_ingredients": [{"name": "ARSENIC TRIOXIDE", "strength": "2 mg/mL"}], "application_number": "ANDA215359", "marketing_category": "ANDA", "marketing_start_date": "20220519", "listing_expiration_date": "20261231"}