FDA.reportPublic FDA data

Arsenic Trioxide

Product NDC
0781-3498
11-digit product format
007813498
Labeler code
0781
Product ID
0781-3498_601a01b0-da7f-4b9d-9f66-bc67371a1268
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Arsenic Trioxide
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sandoz Inc
Application
ANDA215359
Marketing category
ANDA
Marketing start
2022-05-19
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
Arsenic Trioxide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARSENIC TRIOXIDE2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiS7V92P67HO
Rxcui1992545

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
0781-3498-06Arsenic Trioxide6 mL in 1 VIALINJECTION, SOLUTION63
0781-3498-94Arsenic Trioxide1 in 1 CARTONINJECTION, SOLUTION13
0781-3498-94Arsenic Trioxide6 mL in 1 VIALINJECTION, SOLUTION63
0781-3498-95Arsenic Trioxide10 in 1 CARTONINJECTION, SOLUTION103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3498-06ML - Milliliter0781-34988cc14d9c-4962-4c79-9c1d-61ab18eccb1f12022-08-04
0781-3498-94ML - Milliliter0781-349823143b53-c289-4bae-bef8-f2b0071b4ab512022-08-04
0781-3498-95ML - Milliliter0781-3498b5b89dee-11b3-40bd-934e-fd898e9fe2d912022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-3498ARSENIC TRIOXIDE INJECTION, SOLUTION [SANDOZ INC]3Current NDC, Legacy NDC, 4 package rows20241215_a9008658-c2dd-49f4-b1c4-26e232c81957.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1992545arsenic trioxide 12 MG in 6 ML InjectionPSNa9008658-c2dd-49f4-b1c4-26e232c819573
19925456 ML arsenic trioxide 2 MG/ML InjectionSCDa9008658-c2dd-49f4-b1c4-26e232c819573
1992545arsenic trioxide 12 MG per 6 ML InjectionSYa9008658-c2dd-49f4-b1c4-26e232c819573
1992545arsenic trioxide 2 MG/ML per 6 ML InjectionSYa9008658-c2dd-49f4-b1c4-26e232c819573

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-3498-06007813498066 mL in 1 VIAL6 mlHistorical
0781-3498-94007813498941 VIAL in 1 CARTON (0781-3498-94) / 6 mL in 1 VIAL1 vial2022-05-190000-00-00NoNoCurrent
0781-3498-950078134989510 VIAL in 1 CARTON (0781-3498-95) / 6 mL in 1 VIAL (0781-3498-06) 10 vial2022-05-190000-00-00NoNoCurrent