Home NDC 0781-3498 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215359-001 ARSENIC TRIOXIDE ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-12-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215359-001 AP
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.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A215359-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-12-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215359-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-12-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215359-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-12-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215359-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-12-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215359-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-12-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215359-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-12-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215359-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-12-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215359-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-12-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215359-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-12-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215359-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-12-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215359-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-12-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215359-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-12-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215359-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-12-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215359-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-12-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215359-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-12-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A215359-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-12-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A215359-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-12-02 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A215359-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-12-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A215359-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-12-02 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215359-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-12-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215359-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-12-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215359-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-12-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215359-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-12-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215359-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-12-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215359-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-12-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215359-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-12-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215359-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-12-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215359-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-12-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215359-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-12-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215359-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-12-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A215359-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-12-02 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A215359-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-12-02 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215359-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-12-02 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Arsenic Trioxide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ARSENIC TRIOXIDE 2 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination S7V92P67HO Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1992545 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0781-3498-06 Arsenic Trioxide 6 mL in 1 VIAL INJECTION, SOLUTION 6 3 0781-3498-94 Arsenic Trioxide 1 in 1 CARTON INJECTION, SOLUTION 1 3 0781-3498-94 Arsenic Trioxide 6 mL in 1 VIAL INJECTION, SOLUTION 6 3 0781-3498-95 Arsenic Trioxide 10 in 1 CARTON INJECTION, SOLUTION 10 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0781-3498 ARSENIC TRIOXIDE INJECTION, SOLUTION [SANDOZ INC] 3 Current NDC, Legacy NDC, 4 package rows 20241215_a9008658-c2dd-49f4-b1c4-26e232c81957.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0781-3498-06 00781349806 6 mL in 1 VIAL 6 ml Historical 0781-3498-94 00781349894 1 VIAL in 1 CARTON (0781-3498-94) / 6 mL in 1 VIAL 1 vial 2022-05-19 0000-00-00 No No Current 0781-3498-95 00781349895 10 VIAL in 1 CARTON (0781-3498-95) / 6 mL in 1 VIAL (0781-3498-06) 10 vial 2022-05-19 0000-00-00 No No Current