FDA.reportPublic FDA data

ARSENIC TRIOXIDE

Product NDC
72205-172
11-digit product format
722050172
Labeler code
72205
Product ID
72205-172_8849c8f9-ee41-4ccd-8a62-67b04e80a276
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ARSENIC TRIOXIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA217413
Marketing category
ANDA
Marketing start
2023-04-20
Substance
ARSENIC TRIOXIDE
Active strength
2 mg/2mL
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/2mL

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
72205-172-01ARSENIC TRIOXIDE6 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION61
72205-172-07ARSENIC TRIOXIDE10 in 1 CARTONINJECTION, SOLUTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-172-01ML - Milliliter72205-17205ec0d84-d957-475a-876b-dabb362a6b8712026-04-20
72205-172-07ML - Milliliter72205-172b5547a9b-7c5a-4414-8fcf-9603bcf9352212026-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-172ARSENIC TRIOXIDE INJECTION, SOLUTION [NOVADOZ PHARMACEUTICALS LLC]1Current NDC, 2 package rows20240207_8849c8f9-ee41-4ccd-8a62-67b04e80a276.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
829926arsenic trioxide 10 MG in 1 ML InjectionPSN8849c8f9-ee41-4ccd-8a62-67b04e80a2761
82992610 ML arsenic trioxide 1 MG/ML InjectionSCD8849c8f9-ee41-4ccd-8a62-67b04e80a2761
829926arsenic trioxide 10 MG per 1 ML InjectionSY8849c8f9-ee41-4ccd-8a62-67b04e80a2761

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72205-172-01722050172016 mL in 1 VIAL, SINGLE-DOSE6 mlHistorical
72205-172-077220501720710 VIAL, SINGLE-DOSE in 1 CARTON (72205-172-07) / 6 mL in 1 VIAL, SINGLE-DOSE (72205-172-01) 2024-02-06NoNoHistorical