FDA.reportPublic FDA data

Arsenic Trioxide

Product NDC
70121-1483
11-digit product format
701211483
Labeler code
70121
Product ID
70121-1483_773ddbdb-5a14-4f97-8db8-9a874d129153
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Arsenic Trioxide
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA210739
Marketing category
ANDA
Marketing start
2021-01-25
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, 1992545

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
70121-1483-1Arsenic Trioxide10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION107
70121-1483-7Arsenic Trioxide10 in 1 CARTONINJECTION, SOLUTION107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70121-1483-1ML - Milliliter70121-14837f32d4f8-109c-44d4-a5c7-b2a5a7bf0ccb12021-10-08
70121-1483-7ML - Milliliter70121-1483d65017d4-1807-488b-a133-12563d234c3012021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1483ARSENIC TRIOXIDE INJECTION, SOLUTION [AMNEAL PHARMACEUTICALS LLC]7Current NDC, Legacy NDC, 2 package rows20231228_5845022e-8c01-451b-ae49-a28e58c5f845.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
829926arsenic trioxide 10 MG in 1 ML InjectionPSN5845022e-8c01-451b-ae49-a28e58c5f8457
1992545arsenic trioxide 12 MG in 6 ML InjectionPSN5845022e-8c01-451b-ae49-a28e58c5f8457
82992610 ML arsenic trioxide 1 MG/ML InjectionSCD5845022e-8c01-451b-ae49-a28e58c5f8457
19925456 ML arsenic trioxide 2 MG/ML InjectionSCD5845022e-8c01-451b-ae49-a28e58c5f8457
829926arsenic trioxide 10 MG per 1 ML InjectionSY5845022e-8c01-451b-ae49-a28e58c5f8457
1992545arsenic trioxide 12 MG per 6 ML InjectionSY5845022e-8c01-451b-ae49-a28e58c5f8457
1992545arsenic trioxide 2 MG/ML per 6 ML InjectionSY5845022e-8c01-451b-ae49-a28e58c5f8457

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70121-1483-17012114830110 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
70121-1483-77012114830710 VIAL, SINGLE-DOSE in 1 CARTON (70121-1483-7) / 10 mL in 1 VIAL, SINGLE-DOSE (70121-1483-1) 2021-01-250000-00-00NoNoCurrent