Trisenox

Product NDC
63459-601
11-digit product format
634590601
Labeler code
63459
Product ID
63459-601_438426ea-1729-4b61-ad21-b979924204fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Arsenic Trioxide
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Cephalon, LLC
Application
NDA021248
Marketing category
NDA
Marketing start
2017-12-22
Substance
ARSENIC TRIOXIDE
Active strength
2 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
Trisenox
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARSENIC TRIOXIDE2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiS7V92P67HO
Rxcui1992545, 1992547

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
63459-601-06Trisenox10 in 1 CARTONINJECTION, SOLUTION1020
63459-601-11Trisenox6 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION620

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63459-601-06ML - Milliliter63459-601bfa8b740-30be-4a69-bc1f-834506f2dcab12018-01-12
63459-601-11ML - Milliliter63459-601b5213b2a-729a-455f-9dbe-8beea278f12412018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63459-601TRISENOX (ARSENIC TRIOXIDE) INJECTION, SOLUTION [CEPHALON, LLC]16Current NDC, Legacy NDC, 2 package rows20231103_101fc347-d0ad-4aee-8b06-9feb187fd741.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1992545arsenic trioxide 12 MG in 6 ML InjectionPSN101fc347-d0ad-4aee-8b06-9feb187fd74120
1992547Trisenox 12 MG in 6 ML InjectionPSN101fc347-d0ad-4aee-8b06-9feb187fd74120
19925476 ML arsenic trioxide 2 MG/ML Injection [Trisenox]SBD101fc347-d0ad-4aee-8b06-9feb187fd74120
19925456 ML arsenic trioxide 2 MG/ML InjectionSCD101fc347-d0ad-4aee-8b06-9feb187fd74120
1992545arsenic trioxide 12 MG per 6 ML InjectionSY101fc347-d0ad-4aee-8b06-9feb187fd74120
1992545arsenic trioxide 2 MG/ML per 6 ML InjectionSY101fc347-d0ad-4aee-8b06-9feb187fd74120
1992547Trisenox 12 MG per 6 ML InjectionSY101fc347-d0ad-4aee-8b06-9feb187fd74120
1992547Trisenox 2 MG/ML per 6 ML InjectionSY101fc347-d0ad-4aee-8b06-9feb187fd74120

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63459-601-066345906010610 VIAL, SINGLE-DOSE in 1 CARTON (63459-601-06) / 6 mL in 1 VIAL, SINGLE-DOSE (63459-601-11) 2017-12-220000-00-00NoNoCurrent
63459-601-11634590601116 mL in 1 VIAL, SINGLE-DOSE6 mlHistorical