arsenic trioxide

Generic: arsenic trioxide

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name arsenic trioxide
Generic Name arsenic trioxide
Labeler zydus pharmaceuticals usa inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

arsenic trioxide 1 mg/mL

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-997
Product ID 68382-997_22594609-5946-439a-9cf5-5bf6f83037a1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206228
Listing Expiration 2026-12-31
Marketing Start 2018-11-14

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68382997
Hyphenated Format 68382-997

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 ANDA206228 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (68382-997-10) / 10 mL in 1 VIAL (68382-997-01)
source: ndc

Packages (1)

68382-997-10 10 VIAL in 1 CARTON (68382-997-10) / 10 mL in 1 VIAL (68382-997-01)

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": "22594609-5946-439a-9cf5-5bf6f83037a1", "openfda": {"unii": ["S7V92P67HO"], "rxcui": ["829926"], "spl_set_id": ["e9d27f88-de82-4379-b143-4b94b3dd8bbe"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (68382-997-10)  / 10 mL in 1 VIAL (68382-997-01)", "package_ndc": "68382-997-10", "marketing_start_date": "20181114"}], "brand_name": "Arsenic trioxide", "product_id": "68382-997_22594609-5946-439a-9cf5-5bf6f83037a1", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "68382-997", "generic_name": "Arsenic trioxide", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Arsenic trioxide", "active_ingredients": [{"name": "ARSENIC TRIOXIDE", "strength": "1 mg/mL"}], "application_number": "ANDA206228", "marketing_category": "ANDA", "marketing_start_date": "20181114", "listing_expiration_date": "20261231"}