Home NDC 63459-601 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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021248-001 TRISENOX ARSENIC TRIOXIDE 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2000-09-25 N021248-002 TRISENOX ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2017-10-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021248-002 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.
Product history page 1 of 3 · 84 observed 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 2026-08-18 06:07:40 2026-07 N021248-001 TRISENOX 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2000-09-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021248-002 TRISENOX 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2017-10-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021248-001 TRISENOX 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2000-09-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021248-002 TRISENOX 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2017-10-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021248-001 TRISENOX 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2000-09-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021248-002 TRISENOX 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2017-10-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021248-001 TRISENOX 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2000-09-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021248-002 TRISENOX 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2017-10-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021248-001 TRISENOX 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2000-09-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021248-002 TRISENOX 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2017-10-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021248-001 TRISENOX 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2000-09-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021248-002 TRISENOX 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2017-10-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021248-001 TRISENOX 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2000-09-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021248-002 TRISENOX 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2017-10-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021248-001 TRISENOX 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2000-09-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021248-002 TRISENOX 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2017-10-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021248-001 TRISENOX 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2000-09-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021248-002 TRISENOX 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2017-10-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021248-001 TRISENOX 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2000-09-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021248-002 TRISENOX 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2017-10-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021248-001 TRISENOX 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2000-09-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021248-002 TRISENOX 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2017-10-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021248-001 TRISENOX 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2000-09-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021248-002 TRISENOX 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2017-10-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021248-001 TRISENOX 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2000-09-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021248-002 TRISENOX 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2017-10-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021248-001 TRISENOX 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2000-09-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021248-002 TRISENOX 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2017-10-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021248-001 TRISENOX 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2000-09-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021248-002 TRISENOX 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2017-10-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021248-001 TRISENOX 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2000-09-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021248-002 TRISENOX 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2017-10-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021248-001 TRISENOX 1MG/ML INJECTABLE / INJECTION RLD 2000-09-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021248-002 TRISENOX 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2017-10-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021248-001 TRISENOX 1MG/ML INJECTABLE / INJECTION RLD 2000-09-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021248-002 TRISENOX 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2017-10-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021248-001 TRISENOX 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE / INJECTION RLD 2000-09-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021248-002 TRISENOX 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2017-10-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021248-001 TRISENOX 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2000-09-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021248-002 TRISENOX 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2017-10-13 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 78 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Trisenox
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1992545 Internal RxNorm lookup 1992547 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 63459-601-06 Trisenox 10 in 1 CARTON INJECTION, SOLUTION 10 20 63459-601-11 Trisenox 6 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 6 20
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63459-601 TRISENOX (ARSENIC TRIOXIDE) INJECTION, SOLUTION [CEPHALON, LLC] 16 Current NDC, Legacy NDC, 2 package rows 20231103_101fc347-d0ad-4aee-8b06-9feb187fd741.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 63459-601-06 63459060106 10 VIAL, SINGLE-DOSE in 1 CARTON (63459-601-06) / 6 mL in 1 VIAL, SINGLE-DOSE (63459-601-11) 2017-12-22 0000-00-00 No No Current 63459-601-11 63459060111 6 mL in 1 VIAL, SINGLE-DOSE 6 ml Historical