arsenic trioxide

Generic: arsenic trioxide

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name arsenic trioxide
Generic Name arsenic trioxide
Labeler gland pharma limited
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

arsenic trioxide 2 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-462
Product ID 68083-462_dbad2610-ef0d-4733-a28a-3428ff59f56a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215059
Listing Expiration 2026-12-31
Marketing Start 2021-10-07

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083462
Hyphenated Format 68083-462

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 ANDA215059 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (68083-462-10) / 6 mL in 1 VIAL, SINGLE-DOSE (68083-462-01)
source: ndc

Packages (1)

68083-462-10 10 VIAL, SINGLE-DOSE in 1 CARTON (68083-462-10) / 6 mL in 1 VIAL, SINGLE-DOSE (68083-462-01)

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": "dbad2610-ef0d-4733-a28a-3428ff59f56a", "openfda": {"unii": ["S7V92P67HO"], "rxcui": ["829926", "1992545"], "spl_set_id": ["2cb52683-1e74-4831-a771-55a78536cfe5"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (68083-462-10)  / 6 mL in 1 VIAL, SINGLE-DOSE (68083-462-01)", "package_ndc": "68083-462-10", "marketing_start_date": "20211007"}], "brand_name": "Arsenic Trioxide", "product_id": "68083-462_dbad2610-ef0d-4733-a28a-3428ff59f56a", "dosage_form": "INJECTION", "product_ndc": "68083-462", "generic_name": "Arsenic Trioxide", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Arsenic Trioxide", "active_ingredients": [{"name": "ARSENIC TRIOXIDE", "strength": "2 mg/mL"}], "application_number": "ANDA215059", "marketing_category": "ANDA", "marketing_start_date": "20211007", "listing_expiration_date": "20261231"}