arsenic trioxide

Generic: arsenic trioxide

Labeler: orbicular pharmaceutical technologies private limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name arsenic trioxide
Generic Name arsenic trioxide
Labeler orbicular pharmaceutical technologies private limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

arsenic trioxide 2 mg/mL

Manufacturer
Orbicular Pharmaceutical Technologies Private Limited

Identifiers & Regulatory

Product NDC 81607-006
Product ID 81607-006_96a1d1a1-1b78-4199-9770-08093ef03b39
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217413
Listing Expiration 2026-12-31
Marketing Start 2023-05-31

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81607006
Hyphenated Format 81607-006

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
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (81607-006-07) / 6 mL in 1 VIAL, SINGLE-DOSE (81607-006-06)
source: ndc

Packages (1)

81607-006-07 10 VIAL, SINGLE-DOSE in 1 CARTON (81607-006-07) / 6 mL in 1 VIAL, SINGLE-DOSE (81607-006-06)

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": "96a1d1a1-1b78-4199-9770-08093ef03b39", "openfda": {"unii": ["S7V92P67HO"], "rxcui": ["829926", "1992545"], "spl_set_id": ["3b007d59-99ad-409f-a71e-7f4e7d6f6b12"], "manufacturer_name": ["Orbicular Pharmaceutical Technologies Private Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (81607-006-07)  / 6 mL in 1 VIAL, SINGLE-DOSE (81607-006-06)", "package_ndc": "81607-006-07", "marketing_start_date": "20230531"}], "brand_name": "ARSENIC TRIOXIDE", "product_id": "81607-006_96a1d1a1-1b78-4199-9770-08093ef03b39", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "81607-006", "generic_name": "arsenic trioxide", "labeler_name": "Orbicular Pharmaceutical Technologies Private Limited", "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": "20230531", "listing_expiration_date": "20261231"}