arsenic trioxide

Generic: arsenic trioxide

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name arsenic trioxide
Generic Name arsenic trioxide
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

arsenic trioxide 1 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-637
Product ID 63323-637_1ed1c170-ee7f-4f96-98dd-041657d3bdd8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208231
Listing Expiration 2026-12-31
Marketing Start 2018-08-31

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323637
Hyphenated Format 63323-637

Supplemental Identifiers

RxCUI
829926
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 ANDA208231 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-637-10) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-637-03)
source: ndc

Packages (1)

63323-637-10 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-637-10) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-637-03)

Ingredients (1)

arsenic trioxide (1 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": "1ed1c170-ee7f-4f96-98dd-041657d3bdd8", "openfda": {"unii": ["S7V92P67HO"], "rxcui": ["829926"], "spl_set_id": ["a482eccd-8837-47ea-904d-2f2c294d10fa"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (63323-637-10)  / 10 mL in 1 VIAL, SINGLE-DOSE (63323-637-03)", "package_ndc": "63323-637-10", "marketing_start_date": "20180831"}], "brand_name": "Arsenic Trioxide", "product_id": "63323-637_1ed1c170-ee7f-4f96-98dd-041657d3bdd8", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "63323-637", "generic_name": "Arsenic Trioxide", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Arsenic Trioxide", "active_ingredients": [{"name": "ARSENIC TRIOXIDE", "strength": "1 mg/mL"}], "application_number": "ANDA208231", "marketing_category": "ANDA", "marketing_start_date": "20180831", "listing_expiration_date": "20261231"}