arsenic trioxide

Generic: arsenic trioxide

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name arsenic trioxide
Generic Name arsenic trioxide
Labeler zydus lifesciences limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

arsenic trioxide 1 mg/mL

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 49315-005
Product ID 49315-005_a8f76ffc-24cf-4d5b-9bd2-1ace0c66eec5
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 49315005
Hyphenated Format 49315-005

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 (49315-005-10) / 10 mL in 1 VIAL (49315-005-01)
source: ndc

Packages (1)

49315-005-10 10 VIAL in 1 CARTON (49315-005-10) / 10 mL in 1 VIAL (49315-005-01)

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": "a8f76ffc-24cf-4d5b-9bd2-1ace0c66eec5", "openfda": {"unii": ["S7V92P67HO"], "rxcui": ["829926"], "spl_set_id": ["25e8295c-b5d9-4322-a093-d907ab1d1d35"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (49315-005-10)  / 10 mL in 1 VIAL (49315-005-01)", "package_ndc": "49315-005-10", "marketing_start_date": "20181114"}], "brand_name": "Arsenic trioxide", "product_id": "49315-005_a8f76ffc-24cf-4d5b-9bd2-1ace0c66eec5", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "49315-005", "generic_name": "Arsenic trioxide", "labeler_name": "Zydus Lifesciences Limited", "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"}