Arsenic Trioxide

Product NDC: 14789-600
11-digit product format: 147890600
Labeler code: 14789
Product ID: 14789-600_2f76db3f-829a-a45d-e063-6294a90ad7de
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Arsenic Trioxide
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Nexus Pharmaceuticals LLC
Application: ANDA209780
Marketing category: ANDA
Marketing start: 2018-11-19
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A209780-001	ARSENIC TRIOXIDE	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP		2018-11-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209780-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A209780-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209780-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209780-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209780-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209780-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209780-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209780-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209780-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209780-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209780-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209780-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209780-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209780-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209780-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209780-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209780-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209780-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209780-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209780-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209780-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209780-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209780-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209780-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209780-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209780-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209780-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209780-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209780-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209780-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209780-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209780-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209780-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209780-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209780-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209780-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209780-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209780-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209780-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209780-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209780-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-15	`e64feba35796…`

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
2026-08-18 06:07:40	2026-07	A209780-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209780-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209780-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209780-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209780-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209780-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209780-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209780-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209780-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209780-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209780-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209780-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209780-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209780-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209780-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209780-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209780-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209780-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209780-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209780-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209780-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209780-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209780-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209780-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209780-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209780-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209780-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209780-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209780-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209780-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209780-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209780-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209780-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209780-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209780-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209780-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209780-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209780-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209780-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209780-001	AP	1	`e64feba35796…`

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
829926	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2b2a7ed9-5ed3-42fc-b19b-d50700396233	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139	Product name	3	20240506
e5a77e9c-c528-733a-173d-914a234c024b	Product name	5	20240506

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
14789-600-10	2020-03-03	C162847	48780-1	9d75b9d0-a990-f424-e053-dadaa90a57ce	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
14789-600-10	2020-01-31	C162847	48780-1	9d75b9d0-a990-f424-e053-dadaa90a57ce	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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
14789-600-10	Arsenic Trioxide	10 mL in 1 VIAL, SINGLE-DOSE	INJECTION	10		9
14789-600-10	Arsenic Trioxide	10 in 1 CARTON	INJECTION	10		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
14789-600-07	ML - Milliliter	14789-600	b8d72e1c-d291-41ee-95fa-c49aca05d545	1	2020-03-10
14789-600-10	ML - Milliliter	14789-600	84a7f92e-efe6-406b-a07a-774db9f98eb2	1	2018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
14789-600	ARSENIC TRIOXIDE INJECTION [NEXUS PHARMACEUTICALS LLC]	9	Current NDC, Legacy NDC, 2 package rows	20250305_2b2a7ed9-5ed3-42fc-b19b-d50700396233.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Arsenic Trioxide	ARSENIC TRIOXIDE	Nexus Pharmaceuticals LLC	2b2a7ed9-5ed3-42fc-b19b-d50700396233	2025-03-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209780 application number: ANDA209780 ndc (product): 14789-600

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
829926	arsenic trioxide 10 MG in 1 ML Injection	PSN	2b2a7ed9-5ed3-42fc-b19b-d50700396233	9
829926	10 ML arsenic trioxide 1 MG/ML Injection	SCD	2b2a7ed9-5ed3-42fc-b19b-d50700396233	9
829926	arsenic trioxide 10 MG per 1 ML Injection	SY	2b2a7ed9-5ed3-42fc-b19b-d50700396233	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
14789-600-10	14789060010	10 VIAL, SINGLE-DOSE in 1 CARTON (14789-600-10) / 10 mL in 1 VIAL, SINGLE-DOSE	2018-11-19	0000-00-00	No	No	Current