ARSENIC TRIOXIDE

Product NDC: 50742-438
11-digit product format: 507420438
Labeler code: 50742
Product ID: 50742-438_b3030683-7cb9-4143-abbd-d3894313e83d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: arsenic trioxide
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Ingenus Pharmaceuticals, LLC
Application: ANDA209315
Marketing category: ANDA
Marketing start: 2018-11-15
Marketing end: 2028-10-31
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 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…`

Additional Listing Data#

Finished product: Yes
Brand name base: ARSENIC TRIOXIDE

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
c99b01b4-67ff-4793-8375-fe3a21c6c9be	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50742-438-10	ARSENIC TRIOXIDE	1 in 1 CARTON	INJECTION	1		11
50742-438-10	ARSENIC TRIOXIDE	10 mL in 1 VIAL, GLASS	INJECTION	10		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50742-438-10	ML - Milliliter	50742-438	278a5d6d-6614-4559-b5b4-2d1332b8695b	1	2018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50742-438	ARSENIC TRIOXIDE INJECTION [INGENUS PHARMACEUTICALS, LLC]	10	Current NDC, Legacy NDC, 2 package rows	20221129_c99b01b4-67ff-4793-8375-fe3a21c6c9be.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	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 ndc (product): 50742-438

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	c99b01b4-67ff-4793-8375-fe3a21c6c9be	11
829926	10 ML arsenic trioxide 1 MG/ML Injection	SCD	c99b01b4-67ff-4793-8375-fe3a21c6c9be	11
829926	arsenic trioxide 10 MG per 1 ML Injection	SY	c99b01b4-67ff-4793-8375-fe3a21c6c9be	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50742-438-10	50742043810	1 VIAL, GLASS in 1 CARTON (50742-438-10) / 10 mL in 1 VIAL, GLASS	2018-11-15	0000-00-00	No	No	Current