Home NDC 55150-366 ARSENIC TRIOXIDE
Product NDC 55150-366
11-digit product format 551500366
Labeler code 55150
Product ID 55150-366_28fe0658-5c6d-4176-95cc-1b74cf1d8a37
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ARSENIC TRIOXIDE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Eugia US LLC
Application ANDA214011
Marketing category ANDA
Marketing start 2021-10-15
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214011-001 ARSENIC TRIOXIDE ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION 2021-10-15
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 2026-08-18 06:07:40 2026-07 A214011-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION 2021-10-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214011-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION 2021-10-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214011-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION 2021-10-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214011-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION 2021-10-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214011-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION 2021-10-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214011-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION 2021-10-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214011-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION 2021-10-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214011-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION 2021-10-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214011-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214011-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214011-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214011-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214011-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214011-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214011-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214011-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A214011-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A214011-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-15 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A214011-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A214011-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-15 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214011-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214011-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214011-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214011-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214011-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214011-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214011-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214011-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214011-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214011-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214011-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A214011-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A214011-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2021-10-15 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214011-001 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION 2021-10-15 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 55150-366-01 ARSENIC TRIOXIDE 1 in 1 CARTON INJECTION, SOLUTION 1 3 55150-366-01 ARSENIC TRIOXIDE 6 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 6 3 55150-366-10 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 55150-366 ARSENIC TRIOXIDE INJECTION, SOLUTION [EUGIA US LLC] 2 Current NDC, Legacy NDC, 3 package rows 20241109_2a999752-f350-4eff-97e7-e7106dfa85b5.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 55150-366-01 55150036601 1 in 1 CARTON Historical 55150-366-10 55150036610 10 CARTON in 1 CARTON (55150-366-10) / 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-366-01) / 6 mL in 1 VIAL, SINGLE-DOSE 10 carton 2021-10-15 0000-00-00 No No Current