ARSENIC TRIOXIDE

Product NDC
72603-339
11-digit product format
726030339
Labeler code
72603
Product ID
72603-339_2ff17389-2715-4bf0-8357-3f4a95dc7d44
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ARSENIC TRIOXIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Northstar Rx LLC
Application
ANDA217413
Marketing category
ANDA
Marketing start
2023-04-20
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
72603-339-01ARSENIC TRIOXIDE10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION102
72603-339-10ARSENIC TRIOXIDE10 in 1 CARTONINJECTION, SOLUTION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-339ARSENIC TRIOXIDE INJECTION, SOLUTION [NORTHSTAR RX LLC]2Current NDC, 2 package rows20241009_48388282-3768-4309-8982-2766cbc9fd59.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
829926arsenic trioxide 10 MG in 1 ML InjectionPSN48388282-3768-4309-8982-2766cbc9fd592
82992610 ML arsenic trioxide 1 MG/ML InjectionSCD48388282-3768-4309-8982-2766cbc9fd592
829926arsenic trioxide 10 MG per 1 ML InjectionSY48388282-3768-4309-8982-2766cbc9fd592

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-339-017260303390110 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
72603-339-107260303391010 VIAL, SINGLE-DOSE in 1 CARTON (72603-339-10) / 10 mL in 1 VIAL, SINGLE-DOSE (72603-339-01) 2024-11-15NoNoCurrent