Arsenic trioxide

Product NDC
70710-1896
11-digit product format
707101896
Labeler code
70710
Product ID
70710-1896_29dd291f-caa8-4ac4-ab3d-d5769be390f2
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
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
Rxcui1992545

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
70710-1896-1Arsenic trioxide6 mL in 1 VIALINJECTION, SOLUTION64
70710-1896-6Arsenic trioxide10 in 1 CARTONINJECTION, SOLUTION104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1896ARSENIC TRIOXIDE INJECTION, SOLUTION [ZYDUS PHARMACEUTICALS USA INC.]4Current NDC, 2 package rows20250515_3e1d2b63-ccb2-4e97-a009-5983eabf65e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1992545arsenic trioxide 12 MG in 6 ML InjectionPSN3e1d2b63-ccb2-4e97-a009-5983eabf65e44
19925456 ML arsenic trioxide 2 MG/ML InjectionSCD3e1d2b63-ccb2-4e97-a009-5983eabf65e44
1992545arsenic trioxide 12 MG per 6 ML InjectionSY3e1d2b63-ccb2-4e97-a009-5983eabf65e44
1992545arsenic trioxide 2 MG/ML per 6 ML InjectionSY3e1d2b63-ccb2-4e97-a009-5983eabf65e44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70710-1896-1707101896016 mL in 1 VIAL6 mlHistorical
70710-1896-67071018960610 VIAL in 1 CARTON (70710-1896-6) / 6 mL in 1 VIAL (70710-1896-1) 10 vial2023-02-28NoNoCurrent