FDA.reportPublic FDA data

ARSENIC TRIOXIDE

Product NDC
72205-171
11-digit product format
722050171
Labeler code
72205
Product ID
72205-171_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
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
72205-171-01ARSENIC TRIOXIDE10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION101
72205-171-07ARSENIC TRIOXIDE10 in 1 CARTONINJECTION, SOLUTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-171-01ML - Milliliter72205-1711e216fe5-353c-4f18-ab57-397b41e66e6412024-07-12
72205-171-07ML - Milliliter72205-17185d7e2ac-5316-4a31-883e-f28a032a9ba212024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-171ARSENIC 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
72205-171-017220501710110 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
72205-171-077220501710710 VIAL, SINGLE-DOSE in 1 CARTON (72205-171-07) / 10 mL in 1 VIAL, SINGLE-DOSE (72205-171-01) 2024-02-06NoNoHistorical