Arsenic Trioxide

Product NDC
14789-600
11-digit product format
147890600
Labeler code
14789
Product ID
14789-600_2f76db3f-829a-a45d-e063-6294a90ad7de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Arsenic Trioxide
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Nexus Pharmaceuticals LLC
Application
ANDA209780
Marketing category
ANDA
Marketing start
2018-11-19
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14789-600-10Arsenic Trioxide10 mL in 1 VIAL, SINGLE-DOSEINJECTION109
14789-600-10Arsenic Trioxide10 in 1 CARTONINJECTION109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
14789-600-07ML - Milliliter14789-600b8d72e1c-d291-41ee-95fa-c49aca05d54512020-03-10
14789-600-10ML - Milliliter14789-60084a7f92e-efe6-406b-a07a-774db9f98eb212018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14789-600ARSENIC TRIOXIDE INJECTION [NEXUS PHARMACEUTICALS LLC]9Current NDC, Legacy NDC, 2 package rows20250305_2b2a7ed9-5ed3-42fc-b19b-d50700396233.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
829926arsenic trioxide 10 MG in 1 ML InjectionPSN2b2a7ed9-5ed3-42fc-b19b-d507003962339
82992610 ML arsenic trioxide 1 MG/ML InjectionSCD2b2a7ed9-5ed3-42fc-b19b-d507003962339
829926arsenic trioxide 10 MG per 1 ML InjectionSY2b2a7ed9-5ed3-42fc-b19b-d507003962339

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
14789-600-101478906001010 VIAL, SINGLE-DOSE in 1 CARTON (14789-600-10) / 10 mL in 1 VIAL, SINGLE-DOSE2018-11-190000-00-00NoNoCurrent