FDA.reportPublic FDA data

Arsenic Trioxide

Product NDC
23155-869
11-digit product format
231550869
Labeler code
23155
Product ID
23155-869_1f7f1fe4-25b8-4259-8123-17c815934b05
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Arsenic Trioxide
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Inc
Application
ANDA215059
Marketing category
ANDA
Marketing start
2023-06-23
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
23155-869-31Arsenic Trioxide10 mL in 1 VIAL, SINGLE-DOSEINJECTION103
23155-869-41Arsenic Trioxide10 in 1 CARTONINJECTION103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-869-31ML - Milliliter23155-869c277737e-337e-44ba-b8aa-09cce0246b4912023-09-05
23155-869-41ML - Milliliter23155-8693d17ce71-05be-43b4-99a5-f5c729da62aa12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-869ARSENIC TRIOXIDE INJECTION [HERITAGE PHARMA LABS INC. D/B/A AVET PHARMACEUTICALS INC]2Current NDC, 2 package rows20240514_8dddfe9e-06bf-4983-9c55-71b19da8fcdc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
829926arsenic trioxide 10 MG in 1 ML InjectionPSN8dddfe9e-06bf-4983-9c55-71b19da8fcdc3
1992545arsenic trioxide 12 MG in 6 ML InjectionPSN8dddfe9e-06bf-4983-9c55-71b19da8fcdc3
82992610 ML arsenic trioxide 1 MG/ML InjectionSCD8dddfe9e-06bf-4983-9c55-71b19da8fcdc3
19925456 ML arsenic trioxide 2 MG/ML InjectionSCD8dddfe9e-06bf-4983-9c55-71b19da8fcdc3
829926arsenic trioxide 10 MG per 1 ML InjectionSY8dddfe9e-06bf-4983-9c55-71b19da8fcdc3
1992545arsenic trioxide 12 MG per 6 ML InjectionSY8dddfe9e-06bf-4983-9c55-71b19da8fcdc3
1992545arsenic trioxide 2 MG/ML per 6 ML InjectionSY8dddfe9e-06bf-4983-9c55-71b19da8fcdc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
23155-869-312315508693110 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
23155-869-412315508694110 VIAL, SINGLE-DOSE in 1 CARTON (23155-869-41) / 10 mL in 1 VIAL, SINGLE-DOSE (23155-869-31) 2023-06-23NoNoHistorical