Home NDC 63459-600-10 Trisenox
Product NDC 63459-600
Requested package NDC 63459-600-10
11-digit product format 634590600
Labeler code 63459
Product ID 63459-600_5eb7a285-e881-470a-9363-586069286105
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Arsenic Trioxide
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Cephalon, Inc.
Application NDA021248
Marketing category NDA
Marketing start 2000-10-15
Marketing end 2021-08-15
Substance ARSENIC TRIOXIDE
Active strength 1 mg/mL
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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date N021248-001 TRISENOX ARSENIC TRIOXIDE 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2000-09-25 N021248-002 TRISENOX ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP RLD, RS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 · 82 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 2026-02-19 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…2021-12-28 21:50 UTC 2021-12 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 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021248-002 TRISENOX 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2017-10-13 782e0a99824c…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 78 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ARSENIC TRIOXIDE ACTIVE INGREDIENT S7V92P67HO TRISENOX (ARSENIC TRIOXIDE) INJECTION, SOLUTION [CEPHALON, INCORPORATED] 6 ARSENIC CATION (3+) ACTIVE MOIETY C96613F5AV TRISENOX (ARSENIC TRIOXIDE) INJECTION, SOLUTION [CEPHALON, INCORPORATED] 6 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB TRISENOX (ARSENIC TRIOXIDE) INJECTION, SOLUTION [CEPHALON, INCORPORATED] 6 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I TRISENOX (ARSENIC TRIOXIDE) INJECTION, SOLUTION [CEPHALON, INCORPORATED] 6 WATER INACTIVE INGREDIENT 059QF0KO0R TRISENOX (ARSENIC TRIOXIDE) INJECTION, SOLUTION [CEPHALON, INCORPORATED] 6
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Trisenox ARSENIC TRIOXIDE Cephalon, LLC 101fc347-d0ad-4aee-8b06-9feb187fd741 2025-10-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021248 application number: NDA021248
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63459-600-10 63459060010 10 AMPULE in 1 CARTON (63459-600-10) > 10 mL in 1 AMPULE (63459-600-01) 10 ampule 2000-10-15 2021-08-15 No No Current