Home NDC 81607-005 ARSENIC TRIOXIDE
Product NDC 81607-005
11-digit product format 816070005
Labeler code 81607
Product ID 81607-005_96a1d1a1-1b78-4199-9770-08093ef03b39
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name arsenic trioxide
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Orbicular Pharmaceutical Technologies Private Limited
Application ANDA217413
Marketing category ANDA
Marketing start 2023-05-31
Substance ARSENIC TRIOXIDE
Active strength 1 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 A217413-001 ARSENIC TRIOXIDE ARSENIC TRIOXIDE 1MG/ML INJECTABLE / INJECTION AP 2023-04-20 A217413-002 ARSENIC TRIOXIDE ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2023-04-20
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 · 46 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 A217413-001 ARSENIC TRIOXIDE 1MG/ML INJECTABLE / INJECTION AP 2023-04-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217413-002 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2023-04-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217413-001 ARSENIC TRIOXIDE 1MG/ML INJECTABLE / INJECTION AP 2023-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217413-002 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2023-04-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217413-001 ARSENIC TRIOXIDE 1MG/ML INJECTABLE / INJECTION AP 2023-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217413-002 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2023-04-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217413-001 ARSENIC TRIOXIDE 1MG/ML INJECTABLE / INJECTION AP 2023-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217413-002 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2023-04-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217413-001 ARSENIC TRIOXIDE 1MG/ML INJECTABLE / INJECTION AP 2023-04-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217413-002 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2023-04-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217413-001 ARSENIC TRIOXIDE 1MG/ML INJECTABLE / INJECTION AP 2023-04-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217413-002 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2023-04-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217413-001 ARSENIC TRIOXIDE 1MG/ML INJECTABLE / INJECTION AP 2023-04-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217413-002 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2023-04-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217413-001 ARSENIC TRIOXIDE 1MG/ML INJECTABLE / INJECTION AP 2023-04-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217413-002 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2023-04-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217413-001 ARSENIC TRIOXIDE 1MG/ML INJECTABLE / INJECTION AP 2023-04-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217413-002 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2023-04-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217413-001 ARSENIC TRIOXIDE 1MG/ML INJECTABLE / INJECTION AP 2023-04-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217413-002 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2023-04-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217413-001 ARSENIC TRIOXIDE 1MG/ML INJECTABLE / INJECTION AP 2023-04-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217413-002 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2023-04-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217413-001 ARSENIC TRIOXIDE 1MG/ML INJECTABLE / INJECTION AP 2023-04-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217413-002 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2023-04-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217413-001 ARSENIC TRIOXIDE 1MG/ML INJECTABLE / INJECTION AP 2023-04-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217413-002 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2023-04-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217413-001 ARSENIC TRIOXIDE 1MG/ML INJECTABLE / INJECTION AP 2023-04-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217413-002 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2023-04-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217413-001 ARSENIC TRIOXIDE 1MG/ML INJECTABLE / INJECTION AP 2023-04-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A217413-002 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2023-04-20 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217413-001 ARSENIC TRIOXIDE 1MG/ML INJECTABLE / INJECTION AP 2023-04-20 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217413-002 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2023-04-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217413-001 ARSENIC TRIOXIDE 1MG/ML INJECTABLE / INJECTION AP 2023-04-20 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A217413-002 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2023-04-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217413-001 ARSENIC TRIOXIDE 1MG/ML INJECTABLE / INJECTION AP 2023-04-20 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A217413-002 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2023-04-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217413-001 ARSENIC TRIOXIDE 1MG/ML INJECTABLE / INJECTION AP 2023-04-20 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217413-002 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2023-04-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217413-001 ARSENIC TRIOXIDE 1MG/ML INJECTABLE / INJECTION AP 2023-04-20 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217413-002 ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP 2023-04-20 9b2671bbb829…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 46 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 1 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 81607-005-10 ARSENIC TRIOXIDE 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 10 1 81607-005-11 ARSENIC TRIOXIDE 10 in 1 CARTON INJECTION, SOLUTION 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81607-005 ARSENIC TRIOXIDE INJECTION, SOLUTION [ORBICULAR PHARMACEUTICAL TECHNOLOGIES PRIVATE LIMITED] 1 Current NDC, 2 package rows 20230531_3b007d59-99ad-409f-a71e-7f4e7d6f6b12.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ARSENIC TRIOXIDE ARSENIC TRIOXIDE Northstar Rx LLC 48388282-3768-4309-8982-2766cbc9fd59 2024-10-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 217413 application number: ANDA217413 ARSENIC TRIOXIDE ARSENIC TRIOXIDE Novadoz Pharmaceuticals LLC 8849c8f9-ee41-4ccd-8a62-67b04e80a276 2024-02-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 217413 application number: ANDA217413 ARSENIC TRIOXIDE ARSENIC TRIOXIDE Sintetica US LLC d921f52f-2f38-4300-ae40-31f00b3a500a 2023-11-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 217413 application number: ANDA217413 ARSENIC TRIOXIDE ARSENIC TRIOXIDE Orbicular Pharmaceutical Technologies Private Limited 3b007d59-99ad-409f-a71e-7f4e7d6f6b12 2023-05-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 217413 application number: ANDA217413 ndc (product): 81607-005
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 81607-005-10 81607000510 10 mL in 1 VIAL, SINGLE-DOSE 10 ml Historical 81607-005-11 81607000511 10 VIAL, SINGLE-DOSE in 1 CARTON (81607-005-11) / 10 mL in 1 VIAL, SINGLE-DOSE (81607-005-10) 2023-05-31 No No Current