Arsenic Trioxide

Product NDC
25021-226
11-digit product format
250210226
Labeler code
25021
Product ID
25021-226_4c30347e-fd7f-418b-b85b-637b607c09fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Arsenic Trioxide
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA215059
Marketing category
ANDA
Marketing start
2023-02-15
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, 1992545

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
25021-226-10Arsenic Trioxide10 mL in 1 VIALINJECTION101
25021-226-10Arsenic Trioxide10 in 1 CARTONINJECTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-226-10ML - Milliliter25021-2269eb5c41f-fe34-49f1-b619-858ba85ac3d912023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-226ARSENIC TRIOXIDE INJECTION [SAGENT PHARMACEUTICALS]1Current NDC, 2 package rows20230215_7fe0fe9f-e87b-44ab-b92c-9b3d23942063.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
829926arsenic trioxide 10 MG in 1 ML InjectionPSN7fe0fe9f-e87b-44ab-b92c-9b3d239420631
1992545arsenic trioxide 12 MG in 6 ML InjectionPSN7fe0fe9f-e87b-44ab-b92c-9b3d239420631
82992610 ML arsenic trioxide 1 MG/ML InjectionSCD7fe0fe9f-e87b-44ab-b92c-9b3d239420631
19925456 ML arsenic trioxide 2 MG/ML InjectionSCD7fe0fe9f-e87b-44ab-b92c-9b3d239420631
829926arsenic trioxide 10 MG per 1 ML InjectionSY7fe0fe9f-e87b-44ab-b92c-9b3d239420631
1992545arsenic trioxide 12 MG per 6 ML InjectionSY7fe0fe9f-e87b-44ab-b92c-9b3d239420631
1992545arsenic trioxide 2 MG/ML per 6 ML InjectionSY7fe0fe9f-e87b-44ab-b92c-9b3d239420631

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-226-102502102261010 VIAL in 1 CARTON (25021-226-10) / 10 mL in 1 VIAL10 vial2023-02-15NoNoHistorical