Arsenic trioxide

Product NDC: 49315-007
11-digit product format: 493150007
Labeler code: 49315
Product ID: 49315-007_e80b0973-e6e5-4914-b5f0-4528d7fa7285
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Arsenic trioxide
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Zydus Lifesciences Limited
Application: ANDA206228
Marketing category: ANDA
Marketing start: 2019-09-03
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A206228-001	ARSENIC TRIOXIDE	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP		2018-11-13
A206228-002	ARSENIC TRIOXIDE	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION	AP		2019-08-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A206228-001	AP
A206228-002	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 3 · 83 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	A206228-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206228-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION	AP	2019-08-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206228-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206228-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION	AP	2019-08-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206228-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206228-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION	AP	2019-08-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206228-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206228-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION	AP	2019-08-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206228-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206228-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION	AP	2019-08-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206228-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206228-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION	AP	2019-08-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206228-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206228-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION	AP	2019-08-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206228-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206228-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION	AP	2019-08-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206228-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206228-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION	AP	2019-08-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206228-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206228-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION	AP	2019-08-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206228-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206228-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION	AP	2019-08-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206228-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206228-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION	AP	2019-08-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206228-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206228-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION	AP	2019-08-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206228-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206228-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION	AP	2019-08-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206228-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206228-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION	AP	2019-08-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206228-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206228-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION	AP	2019-08-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206228-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206228-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION	AP	2019-08-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206228-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206228-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION	AP	2019-08-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206228-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206228-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION	AP	2019-08-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206228-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2018-11-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206228-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION	AP	2019-08-30	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 83 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	A206228-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206228-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206228-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206228-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206228-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206228-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206228-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206228-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206228-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206228-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206228-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206228-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206228-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206228-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206228-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206228-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206228-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206228-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206228-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206228-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206228-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206228-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206228-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206228-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206228-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206228-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206228-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206228-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206228-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206228-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206228-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206228-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206228-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206228-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206228-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206228-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206228-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206228-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206228-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206228-002	AP	1	`bb7c543d1eb4…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2ad7bb19-6152-4158-a179-2388e86a981f	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
49315-007-01	Arsenic trioxide	6 mL in 1 VIAL	INJECTION, SOLUTION	6		3
49315-007-10	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
49315-007	ARSENIC TRIOXIDE INJECTION, SOLUTION [ZYDUS LIFESCIENCES LIMITED]	3	Current NDC, Legacy NDC, 2 package rows	20221108_2ad7bb19-6152-4158-a179-2388e86a981f.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Arsenic trioxide	ARSENIC TRIOXIDE	Zydus Pharmaceuticals USA Inc.	3e1d2b63-ccb2-4e97-a009-5983eabf65e4	2025-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206228 application number: ANDA206228
Arsenic trioxide	ARSENIC TRIOXIDE	Zydus Pharmaceuticals USA Inc.	ae5cae02-ca57-4da5-8940-81253fdb8679	2025-05-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206228 application number: ANDA206228
Arsenic trioxide	ARSENIC TRIOXIDE	Zydus Pharmaceuticals USA Inc.	e9d27f88-de82-4379-b143-4b94b3dd8bbe	2025-02-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206228 application number: ANDA206228
Arsenic trioxide	ARSENIC TRIOXIDE	Zydus Pharmaceuticals USA Inc.	e1ad5d87-e65e-402f-86b5-e641fc4e61ab	2025-02-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206228 application number: ANDA206228
Arsenic trioxide	ARSENIC TRIOXIDE	Zydus Lifesciences Limited	25e8295c-b5d9-4322-a093-d907ab1d1d35	2022-11-05		Exact identifier application applno (ANDA): 206228 application number: ANDA206228
Arsenic trioxide	ARSENIC TRIOXIDE	Zydus Lifesciences Limited	2ad7bb19-6152-4158-a179-2388e86a981f	2022-11-05		Exact identifier application applno (ANDA): 206228 application number: ANDA206228 ndc (product): 49315-007

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
1992545	arsenic trioxide 12 MG in 6 ML Injection	PSN	2ad7bb19-6152-4158-a179-2388e86a981f	3
1992545	6 ML arsenic trioxide 2 MG/ML Injection	SCD	2ad7bb19-6152-4158-a179-2388e86a981f	3
1992545	arsenic trioxide 12 MG per 6 ML Injection	SY	2ad7bb19-6152-4158-a179-2388e86a981f	3
1992545	arsenic trioxide 2 MG/ML per 6 ML Injection	SY	2ad7bb19-6152-4158-a179-2388e86a981f	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49315-007-01	49315000701	6 mL in 1 VIAL	6 ml					Historical
49315-007-10	49315000710	10 VIAL in 1 CARTON (49315-007-10) / 6 mL in 1 VIAL (49315-007-01)	10 vial	2019-09-03	0000-00-00	No	No	Current