arsenic trioxide

Generic: arsenic trioxide

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

Drug Facts

Product Profile

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

arsenic trioxide 2 mg/mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-366
Product ID 55150-366_28fe0658-5c6d-4176-95cc-1b74cf1d8a37
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214011
Listing Expiration 2026-12-31
Marketing Start 2021-10-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55150366
Hyphenated Format 55150-366

Supplemental Identifiers

RxCUI
1992545
UPC
0355150366019 0355150366101
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 ANDA214011 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 10 CARTON in 1 CARTON (55150-366-10) / 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-366-01) / 6 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

55150-366-10 10 CARTON in 1 CARTON (55150-366-10) / 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-366-01) / 6 mL in 1 VIAL, SINGLE-DOSE

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": "28fe0658-5c6d-4176-95cc-1b74cf1d8a37", "openfda": {"upc": ["0355150366019", "0355150366101"], "unii": ["S7V92P67HO"], "rxcui": ["1992545"], "spl_set_id": ["2a999752-f350-4eff-97e7-e7106dfa85b5"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 CARTON in 1 CARTON (55150-366-10)  / 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-366-01)  / 6 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "55150-366-10", "marketing_start_date": "20211015"}], "brand_name": "ARSENIC TRIOXIDE", "product_id": "55150-366_28fe0658-5c6d-4176-95cc-1b74cf1d8a37", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "55150-366", "generic_name": "ARSENIC TRIOXIDE", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ARSENIC TRIOXIDE", "active_ingredients": [{"name": "ARSENIC TRIOXIDE", "strength": "2 mg/mL"}], "application_number": "ANDA214011", "marketing_category": "ANDA", "marketing_start_date": "20211015", "listing_expiration_date": "20261231"}