Arsenic Trioxide

Product NDC: 70860-217
Requested package NDC: 70860-217-10
11-digit product format: 708600217
Labeler code: 70860
Product ID: 70860-217_80ae6afb-9ea9-466e-a9ba-5309224e7efa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: arsenic trioxide
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Athenex Pharmaceutical Division, LLC.
Application: ANDA209315
Marketing category: ANDA
Marketing start: 2020-11-30
Marketing end: 0000-00-00
Substance: ARSENIC TRIOXIDE
Active strength: 1 mg/mL
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70860-217	70860-217-10	D	Discontinued by firm		2026-08-10

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 · 10 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…`

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
A209315-001	ARSENIC TRIOXIDE	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP		2018-11-15
A209315-002	ARSENIC TRIOXIDE	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION			2021-01-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A209315-001	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 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209315-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209315-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION		2021-01-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209315-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209315-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION		2021-01-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209315-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209315-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION		2021-01-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209315-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209315-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION		2021-01-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209315-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209315-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION		2021-01-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209315-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209315-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION		2021-01-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209315-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209315-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION		2021-01-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209315-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209315-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION		2021-01-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209315-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209315-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION		2021-01-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209315-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209315-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION		2021-01-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209315-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209315-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION		2021-01-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209315-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209315-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION		2021-01-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209315-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209315-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION		2021-01-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209315-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209315-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION		2021-01-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209315-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209315-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION		2021-01-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209315-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209315-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION		2021-01-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209315-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209315-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION		2021-01-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209315-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209315-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209315-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION		2021-01-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209315-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209315-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION		2021-01-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209315-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209315-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209315-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209315-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209315-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209315-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209315-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209315-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209315-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209315-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209315-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209315-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209315-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209315-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209315-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209315-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209315-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209315-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209315-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209315-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209315-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209315-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209315-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A209315-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209315-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209315-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209315-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209315-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209315-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209315-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209315-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209315-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209315-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209315-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209315-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209315-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209315-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209315-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209315-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209315-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209315-001	AP	1	`e64feba35796…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70860-217-10	2024-02-27	C162847	48780-1	1030e365-1153-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use ARSENIC TRIOXIDE INJECTION safely and effectively. See full prescribing information for ARSENIC TRIOXIDE INJECTION. ARSENIC TRIOXIDE injection, for intravenous use Initial U.S. Approval: 2000
70860-217-10	2024-01-30	C162847	48780-1	1030e365-1153-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use ARSENIC TRIOXIDE INJECTION safely and effectively. See full prescribing information for ARSENIC TRIOXIDE INJECTION. ARSENIC TRIOXIDE injection, for intravenous use Initial U.S. Approval: 2000

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70860-217-10	ML - Milliliter	70860-217	d8c264d0-d022-4ad8-a7e1-ba646f0e36ac	1	2021-03-02

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
ARSENIC TRIOXIDE	ARSENIC TRIOXIDE	Ingenus Pharmaceuticals, LLC	c99b01b4-67ff-4793-8375-fe3a21c6c9be	2023-01-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209315 application number: ANDA209315

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
S7V92P67HO	ARSENIC TRIOXIDE	1327-53-3	ARSENIC TRIOXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70860-217-10	70860021710	1 VIAL in 1 CARTON (70860-217-10) > 10 mL in 1 VIAL	1 vial	2020-11-30	0000-00-00	No	No	Current