Arsenic trioxide

Product NDC
70710-1895
11-digit product format
707101895
Labeler code
70710
Product ID
70710-1895_db2757aa-d8c7-4114-b4bb-5eeec0df762f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Arsenic trioxide
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA206228
Marketing category
ANDA
Marketing start
2023-02-28
Substance
ARSENIC TRIOXIDE
Active strength
1 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Arsenic trioxide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARSENIC TRIOXIDE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiS7V92P67HO
Rxcui829926

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1895-1Arsenic trioxide10 mL in 1 VIALINJECTION, SOLUTION103
70710-1895-6Arsenic trioxide10 in 1 CARTONINJECTION, SOLUTION103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1895-1ML - Milliliter70710-1895c8cc2837-2150-4df1-8a82-bb9797d263a812023-05-05
70710-1895-6ML - Milliliter70710-18950beb2a76-a3ee-4595-bd39-78a4e0f6cc1212023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1895ARSENIC TRIOXIDE INJECTION, SOLUTION [ZYDUS PHARMACEUTICALS USA INC.]3Current NDC, 2 package rows20250514_ae5cae02-ca57-4da5-8940-81253fdb8679.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
829926arsenic trioxide 10 MG in 1 ML InjectionPSNae5cae02-ca57-4da5-8940-81253fdb86793
82992610 ML arsenic trioxide 1 MG/ML InjectionSCDae5cae02-ca57-4da5-8940-81253fdb86793
829926arsenic trioxide 10 MG per 1 ML InjectionSYae5cae02-ca57-4da5-8940-81253fdb86793

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70710-1895-17071018950110 mL in 1 VIAL10 mlHistorical
70710-1895-67071018950610 VIAL in 1 CARTON (70710-1895-6) / 10 mL in 1 VIAL (70710-1895-1) 10 vial2023-02-28NoNoCurrent