Arsenic Trioxide

Product NDC
23155-870
11-digit product format
231550870
Labeler code
23155
Product ID
23155-870_1f7f1fe4-25b8-4259-8123-17c815934b05
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Arsenic Trioxide
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Inc
Application
ANDA215059
Marketing category
ANDA
Marketing start
2023-06-23
Substance
ARSENIC TRIOXIDE
Active strength
2 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A215059-001ARSENIC TRIOXIDEARSENIC TRIOXIDE2MG/MLINJECTABLE / INJECTIONAP2021-10-07
A215059-002ARSENIC TRIOXIDEARSENIC TRIOXIDE1MG/MLINJECTABLE / INJECTIONAP2022-04-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A215059-001AP
A215059-002AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 64 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A215059-001ARSENIC TRIOXIDE2MG/MLINJECTABLE / INJECTIONAP2021-10-07caaa826d4ba7…
2026-08-18 06:07:402026-07A215059-002ARSENIC TRIOXIDE1MG/MLINJECTABLE / INJECTIONAP2022-04-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215059-001ARSENIC TRIOXIDE2MG/MLINJECTABLE / INJECTIONAP2021-10-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215059-002ARSENIC TRIOXIDE1MG/MLINJECTABLE / INJECTIONAP2022-04-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215059-001ARSENIC TRIOXIDE2MG/MLINJECTABLE / INJECTIONAP2021-10-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215059-002ARSENIC TRIOXIDE1MG/MLINJECTABLE / INJECTIONAP2022-04-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A215059-001ARSENIC TRIOXIDE2MG/MLINJECTABLE / INJECTIONAP2021-10-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215059-002ARSENIC TRIOXIDE1MG/MLINJECTABLE / INJECTIONAP2022-04-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215059-001ARSENIC TRIOXIDE2MG/MLINJECTABLE / INJECTIONAP2021-10-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215059-002ARSENIC TRIOXIDE1MG/MLINJECTABLE / INJECTIONAP2022-04-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215059-001ARSENIC TRIOXIDE2MG/MLINJECTABLE / INJECTIONAP2021-10-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215059-002ARSENIC TRIOXIDE1MG/MLINJECTABLE / INJECTIONAP2022-04-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215059-001ARSENIC TRIOXIDE2MG/MLINJECTABLE / INJECTIONAP2021-10-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215059-002ARSENIC TRIOXIDE1MG/MLINJECTABLE / INJECTIONAP2022-04-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215059-001ARSENIC TRIOXIDE2MG/MLINJECTABLE / INJECTIONAP2021-10-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215059-002ARSENIC TRIOXIDE1MG/MLINJECTABLE / INJECTIONAP2022-04-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215059-001ARSENIC TRIOXIDE2MG/MLINJECTABLE / INJECTIONAP2021-10-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215059-002ARSENIC TRIOXIDE1MG/MLINJECTABLE / INJECTIONAP2022-04-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215059-001ARSENIC TRIOXIDE2MG/MLINJECTABLE / INJECTIONAP2021-10-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215059-002ARSENIC TRIOXIDE1MG/MLINJECTABLE / INJECTIONAP2022-04-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215059-001ARSENIC TRIOXIDE2MG/MLINJECTABLE / INJECTIONAP2021-10-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A215059-002ARSENIC TRIOXIDE1MG/MLINJECTABLE / INJECTIONAP2022-04-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215059-001ARSENIC TRIOXIDE2MG/MLINJECTABLE / INJECTIONAP2021-10-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215059-002ARSENIC TRIOXIDE1MG/MLINJECTABLE / INJECTIONAP2022-04-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215059-001ARSENIC TRIOXIDE2MG/MLINJECTABLE / INJECTIONAP2021-10-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215059-002ARSENIC TRIOXIDE1MG/MLINJECTABLE / INJECTIONAP2022-04-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215059-001ARSENIC TRIOXIDE2MG/MLINJECTABLE / INJECTIONAP2021-10-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215059-002ARSENIC TRIOXIDE1MG/MLINJECTABLE / INJECTIONAP2022-04-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215059-001ARSENIC TRIOXIDE2MG/MLINJECTABLE / INJECTIONAP2021-10-078072bd15b7f6…
2024-05-31 18:47 UTC2024-05A215059-002ARSENIC TRIOXIDE1MG/MLINJECTABLE / INJECTIONAP2022-04-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215059-001ARSENIC TRIOXIDE2MG/MLINJECTABLE / INJECTIONAP2021-10-075c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215059-002ARSENIC TRIOXIDE1MG/MLINJECTABLE / INJECTIONAP2022-04-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A215059-001ARSENIC TRIOXIDE2MG/MLINJECTABLE / INJECTIONAP2021-10-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A215059-001ARSENIC TRIOXIDE2MG/MLINJECTABLE / INJECTIONAP2021-10-074b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A215059-001ARSENIC TRIOXIDE2MG/MLINJECTABLE / INJECTIONAP2021-10-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A215059-001ARSENIC TRIOXIDE2MG/MLINJECTABLE / INJECTIONAP2021-10-07782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215059-001ARSENIC TRIOXIDE2MG/MLINJECTABLE / INJECTIONAP2021-10-076a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215059-002ARSENIC TRIOXIDE1MG/MLINJECTABLE / INJECTIONAP2022-04-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215059-001ARSENIC TRIOXIDE2MG/MLINJECTABLE / INJECTIONAP2021-10-071c564ffb4f44…
2024-02-18 07:12 UTC2024-02A215059-002ARSENIC TRIOXIDE1MG/MLINJECTABLE / INJECTIONAP2022-04-221c564ffb4f44…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 64 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A215059-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A215059-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215059-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215059-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215059-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215059-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215059-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215059-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215059-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215059-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215059-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215059-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215059-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215059-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215059-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215059-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215059-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215059-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215059-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215059-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215059-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A215059-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215059-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215059-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215059-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215059-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215059-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215059-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215059-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A215059-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215059-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215059-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A215059-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A215059-001AP14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A215059-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A215059-001AP1782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215059-001AP16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215059-002AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215059-001AP11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A215059-002AP11c564ffb4f44…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
S7V92P67HOInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
829926Internal RxNorm lookup
1992545Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8dddfe9e-06bf-4983-9c55-71b19da8fcdcAvailable on FDA.report

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
23155-870-31Arsenic Trioxide6 mL in 1 VIAL, SINGLE-DOSEINJECTION63
23155-870-41Arsenic Trioxide10 in 1 CARTONINJECTION103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-870-31ML - Milliliter23155-870a1a7b1fe-0417-4707-a38d-e18da369c30212024-05-16
23155-870-41ML - Milliliter23155-8705a25c131-818f-457c-b9f2-8e97a4eed30412023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-870ARSENIC TRIOXIDE INJECTION [HERITAGE PHARMA LABS INC. D/B/A AVET PHARMACEUTICALS INC]2Current NDC, 2 package rows20240514_8dddfe9e-06bf-4983-9c55-71b19da8fcdc.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Arsenic TrioxideARSENIC TRIOXIDEHeritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Inc8dddfe9e-06bf-4983-9c55-71b19da8fcdc2025-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215059
application number: ANDA215059
ndc (product): 23155-870
Arsenic TrioxideARSENIC TRIOXIDEGland Pharma Limited2cb52683-1e74-4831-a771-55a78536cfe52024-09-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215059
application number: ANDA215059
Arsenic TrioxideARSENIC TRIOXIDESagent Pharmaceuticals7fe0fe9f-e87b-44ab-b92c-9b3d239420632022-11-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215059
application number: ANDA215059

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
829926arsenic trioxide 10 MG in 1 ML InjectionPSN8dddfe9e-06bf-4983-9c55-71b19da8fcdc3
1992545arsenic trioxide 12 MG in 6 ML InjectionPSN8dddfe9e-06bf-4983-9c55-71b19da8fcdc3
82992610 ML arsenic trioxide 1 MG/ML InjectionSCD8dddfe9e-06bf-4983-9c55-71b19da8fcdc3
19925456 ML arsenic trioxide 2 MG/ML InjectionSCD8dddfe9e-06bf-4983-9c55-71b19da8fcdc3
829926arsenic trioxide 10 MG per 1 ML InjectionSY8dddfe9e-06bf-4983-9c55-71b19da8fcdc3
1992545arsenic trioxide 12 MG per 6 ML InjectionSY8dddfe9e-06bf-4983-9c55-71b19da8fcdc3
1992545arsenic trioxide 2 MG/ML per 6 ML InjectionSY8dddfe9e-06bf-4983-9c55-71b19da8fcdc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
23155-870-31231550870316 mL in 1 VIAL, SINGLE-DOSE6 mlHistorical
23155-870-412315508704110 VIAL, SINGLE-DOSE in 1 CARTON (23155-870-41) / 6 mL in 1 VIAL, SINGLE-DOSE (23155-870-31) 2023-06-23NoNoCurrent