Home NDC 25021-227 Arsenic Trioxide
Product NDC 25021-227
11-digit product format 250210227
Labeler code 25021
Product ID 25021-227_4c30347e-fd7f-418b-b85b-637b607c09fb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Arsenic Trioxide
Dosage form INJECTION
Route INTRAVENOUS
Labeler Sagent Pharmaceuticals
Application ANDA215059
Marketing category ANDA
Marketing start 2023-02-15
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 A215059-001 ARSENIC TRIOXIDE ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-07 A215059-002 ARSENIC TRIOXIDE ARSENIC TRIOXIDE 1MG/ML INJECTABLE / INJECTION AP 2022-04-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 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 A215059-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215059-002 ARSENIC TRIOXIDE 1MG/ML INJECTABLE / INJECTION AP 2022-04-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215059-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215059-002 ARSENIC TRIOXIDE 1MG/ML INJECTABLE / INJECTION AP 2022-04-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215059-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215059-002 ARSENIC TRIOXIDE 1MG/ML INJECTABLE / INJECTION AP 2022-04-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215059-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215059-002 ARSENIC TRIOXIDE 1MG/ML INJECTABLE / INJECTION AP 2022-04-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215059-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215059-002 ARSENIC TRIOXIDE 1MG/ML INJECTABLE / INJECTION AP 2022-04-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215059-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215059-002 ARSENIC TRIOXIDE 1MG/ML INJECTABLE / INJECTION AP 2022-04-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215059-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215059-002 ARSENIC TRIOXIDE 1MG/ML INJECTABLE / INJECTION AP 2022-04-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215059-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215059-002 ARSENIC TRIOXIDE 1MG/ML INJECTABLE / INJECTION AP 2022-04-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215059-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215059-002 ARSENIC TRIOXIDE 1MG/ML INJECTABLE / INJECTION AP 2022-04-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215059-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215059-002 ARSENIC TRIOXIDE 1MG/ML INJECTABLE / INJECTION AP 2022-04-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215059-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215059-002 ARSENIC TRIOXIDE 1MG/ML INJECTABLE / INJECTION AP 2022-04-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215059-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215059-002 ARSENIC TRIOXIDE 1MG/ML INJECTABLE / INJECTION AP 2022-04-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215059-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215059-002 ARSENIC TRIOXIDE 1MG/ML INJECTABLE / INJECTION AP 2022-04-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215059-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215059-002 ARSENIC TRIOXIDE 1MG/ML INJECTABLE / INJECTION AP 2022-04-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215059-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-07 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A215059-002 ARSENIC TRIOXIDE 1MG/ML INJECTABLE / INJECTION AP 2022-04-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215059-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-07 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215059-002 ARSENIC TRIOXIDE 1MG/ML INJECTABLE / INJECTION AP 2022-04-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A215059-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A215059-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-07 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A215059-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A215059-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-07 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215059-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-07 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215059-002 ARSENIC TRIOXIDE 1MG/ML INJECTABLE / INJECTION AP 2022-04-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215059-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-07 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A215059-002 ARSENIC TRIOXIDE 1MG/ML INJECTABLE / INJECTION AP 2022-04-22 1c564ffb4f44…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 64 observed states.
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 829926 Internal RxNorm lookup 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 25021-227-06 Arsenic Trioxide 6 mL in 1 VIAL INJECTION 6 1 25021-227-06 Arsenic Trioxide 10 in 1 CARTON INJECTION 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 25021-227 ARSENIC TRIOXIDE INJECTION [SAGENT PHARMACEUTICALS] 1 Current NDC, 2 package rows 20230215_7fe0fe9f-e87b-44ab-b92c-9b3d23942063.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 25021-227-06 25021022706 10 VIAL in 1 CARTON (25021-227-06) / 6 mL in 1 VIAL 10 vial 2023-02-15 No No Current