FDA.reportPublic FDA data

ARSENIC TRIOXIDE

Product NDC
83090-010
11-digit product format
830900010
Labeler code
83090
Product ID
83090-010_d95da146-99a2-491f-be7e-28e5fd86928f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
arsenic trioxide
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sintetica US LLC
Application
ANDA217413
Marketing category
ANDA
Marketing start
2023-11-09
Substance
ARSENIC TRIOXIDE
Active strength
2 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 TRIOXIDE2 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
83090-010-01ARSENIC TRIOXIDE1 in 1 CARTONINJECTION, SOLUTION11
83090-010-05ARSENIC TRIOXIDE6 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION61
83090-010-10ARSENIC TRIOXIDE10 in 1 CARTONINJECTION, SOLUTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83090-010-01ML - Milliliter83090-0103fc4acf5-3d97-499d-9b24-1fbdf64d70cd12024-04-05
83090-010-10ML - Milliliter83090-01079d73c40-3f76-4217-9b47-c954e7e5edf012024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83090-010ARSENIC TRIOXIDE INJECTION, SOLUTION [SINTETICA US LLC]1Current NDC, 3 package rows20240119_d921f52f-2f38-4300-ae40-31f00b3a500a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
829926arsenic trioxide 10 MG in 1 ML InjectionPSNd921f52f-2f38-4300-ae40-31f00b3a500a1
1992545arsenic trioxide 12 MG in 6 ML InjectionPSNd921f52f-2f38-4300-ae40-31f00b3a500a1
82992610 ML arsenic trioxide 1 MG/ML InjectionSCDd921f52f-2f38-4300-ae40-31f00b3a500a1
19925456 ML arsenic trioxide 2 MG/ML InjectionSCDd921f52f-2f38-4300-ae40-31f00b3a500a1
829926arsenic trioxide 10 MG per 1 ML InjectionSYd921f52f-2f38-4300-ae40-31f00b3a500a1
1992545arsenic trioxide 12 MG per 6 ML InjectionSYd921f52f-2f38-4300-ae40-31f00b3a500a1
1992545arsenic trioxide 2 MG/ML per 6 ML InjectionSYd921f52f-2f38-4300-ae40-31f00b3a500a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83090-010-01830900010011 VIAL, SINGLE-DOSE in 1 CARTON (83090-010-01) / 6 mL in 1 VIAL, SINGLE-DOSE (83090-010-05) 2023-11-09NoNoCurrent
83090-010-05830900010056 mL in 1 VIAL, SINGLE-DOSE6 mlHistorical
83090-010-108309000101010 VIAL, SINGLE-DOSE in 1 CARTON (83090-010-10) / 6 mL in 1 VIAL, SINGLE-DOSE (83090-010-05) 2023-11-09NoNoCurrent