Home NDC 63459-601 Trisenox
Product NDC 63459-601
11-digit product format 634590601
Labeler code 63459
Product ID 63459-601_075b9658-a8e1-4b62-a786-6670159252c2
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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date N021248-001 TRISENOX ARSENIC TRIOXIDE 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2000-09-25 N021248-002 TRISENOX ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP RLD, RS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 · 86 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 2026-09-14 22:38:34 2026-08 N021248-001 TRISENOX 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2000-09-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021248-002 TRISENOX 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2017-10-13 84e616aacf4f…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N021248-001 TRISENOX 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2000-09-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021248-002 TRISENOX 2MG/ML INJECTABLE /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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 78 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Trisenox
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ARSENIC TRIOXIDE 2 mg/mL
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
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