Barhemsys

Product NDC: 71390-125
11-digit product format: 713900125
Labeler code: 71390
Product ID: 71390-125_b4cf2d39-67e7-459b-add4-5454b1029c14
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amisulpride
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Acacia Pharma Ltd
Application: NDA209510
Marketing category: NDA
Marketing start: 2020-02-27
Marketing end: 2030-11-30
Substance: AMISULPRIDE
Active strength: 2.5 mg/mL
Pharmacologic classes: Dopamine D2 Antagonists [MoA], Dopamine-2 Receptor Antagonist [EPC]
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
N209510-001	BARHEMSYS	AMISULPRIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-02-26
N209510-002	BARHEMSYS	AMISULPRIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-09-01

Orange Book patents#

Current patent rows page 1 of 1 · 32 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209510-001	10525033	2031-03-10		Drug product	2020-03-16
N209510-001	12194022	2031-03-10	U-1744		2025-01-29
N209510-001	12194022	2031-03-10	U-3467		2025-01-29
N209510-001	9545426	2031-03-10	U-1744		2020-03-16
N209510-001	9545426	2031-03-10	U-2754		2020-03-16
N209510-001	9889118	2031-03-10	U-1744		2020-03-16
N209510-001	9889118	2031-03-10	U-2754		2020-03-16
N209510-001	9084765	2034-02-26	U-1744		2020-03-16
N209510-001	9084765	2034-02-26	U-2754		2020-03-16
N209510-001	9084765	2034-02-26	U-3467		2020-03-16
N209510-001	11357753	2038-02-09	U-2754		2022-07-08
N209510-001	12005042	2038-02-09	U-1744		2025-01-08
N209510-001	12005042	2038-02-09	U-2754		2025-01-08
N209510-001	12005042	2038-02-09	U-3467		2025-01-08
N209510-001	12329740	2038-02-09	U-2754		2025-07-02
N209510-001	12329740	2038-02-09	U-3467		2025-07-02
N209510-002	10525033	2031-03-10		Drug product	2022-02-09
N209510-002	12194022	2031-03-10	U-1744		2025-01-29
N209510-002	12194022	2031-03-10	U-3467		2025-01-29
N209510-002	9545426	2031-03-10	U-1744		2022-02-09
N209510-002	9545426	2031-03-10	U-2754		2022-02-09
N209510-002	9889118	2031-03-10	U-1744		2022-02-09
N209510-002	9889118	2031-03-10	U-2754		2022-02-09
N209510-002	9084765	2034-02-26	U-1744		2022-02-09
N209510-002	9084765	2034-02-26	U-2754		2022-02-09
N209510-002	9084765	2034-02-26	U-3467		2022-02-09
N209510-002	11357753	2038-02-09	U-2754		2022-07-08
N209510-002	12005042	2038-02-09	U-1744		2025-01-08
N209510-002	12005042	2038-02-09	U-2754		2025-01-08
N209510-002	12005042	2038-02-09	U-3467		2025-01-08
N209510-002	12329740	2038-02-09	U-2754		2025-07-02
N209510-002	12329740	2038-02-09	U-3467		2025-07-02

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N209510-001	BARHEMSYS	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-002	BARHEMSYS	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-09-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209510-001	BARHEMSYS	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209510-002	BARHEMSYS	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-09-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209510-001	BARHEMSYS	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209510-002	BARHEMSYS	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-09-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209510-001	BARHEMSYS	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209510-002	BARHEMSYS	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-09-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209510-001	BARHEMSYS	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209510-002	BARHEMSYS	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-09-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209510-001	BARHEMSYS	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209510-002	BARHEMSYS	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-09-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209510-001	BARHEMSYS	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209510-002	BARHEMSYS	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-09-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209510-001	BARHEMSYS	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209510-002	BARHEMSYS	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-09-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209510-001	BARHEMSYS	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209510-002	BARHEMSYS	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-09-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209510-001	BARHEMSYS	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209510-002	BARHEMSYS	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-09-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209510-001	BARHEMSYS	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209510-002	BARHEMSYS	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-09-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209510-001	BARHEMSYS	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209510-002	BARHEMSYS	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-09-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209510-001	BARHEMSYS	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209510-002	BARHEMSYS	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-09-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209510-001	BARHEMSYS	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209510-002	BARHEMSYS	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-09-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209510-001	BARHEMSYS	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209510-002	BARHEMSYS	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-09-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209510-001	BARHEMSYS	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209510-002	BARHEMSYS	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-09-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209510-001	BARHEMSYS	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209510-002	BARHEMSYS	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-09-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209510-001	BARHEMSYS	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209510-002	BARHEMSYS	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-09-01	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N209510-001	BARHEMSYS	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209510-002	BARHEMSYS	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-09-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209510-001	BARHEMSYS	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209510-002	BARHEMSYS	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-09-01	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 18 · 695 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N209510-001	10525033	2031-03-10		Drug product	2020-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-001	12194022	2031-03-10	U-1744		2025-01-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-001	12194022	2031-03-10	U-3467		2025-01-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-001	9545426	2031-03-10	U-1744		2020-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-001	9545426	2031-03-10	U-2754		2020-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-001	9889118	2031-03-10	U-2754		2020-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-001	9889118	2031-03-10	U-1744		2020-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-001	9084765	2034-02-26	U-1744		2020-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-001	9084765	2034-02-26	U-2754		2020-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-001	9084765	2034-02-26	U-3467		2020-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-001	11357753	2038-02-09	U-2754		2022-07-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-001	12005042	2038-02-09	U-1744		2025-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-001	12005042	2038-02-09	U-3467		2025-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-001	12005042	2038-02-09	U-2754		2025-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-001	12329740	2038-02-09	U-2754		2025-07-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-001	12329740	2038-02-09	U-3467		2025-07-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-002	10525033	2031-03-10		Drug product	2022-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-002	12194022	2031-03-10	U-1744		2025-01-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-002	12194022	2031-03-10	U-3467		2025-01-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-002	9545426	2031-03-10	U-2754		2022-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-002	9545426	2031-03-10	U-1744		2022-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-002	9889118	2031-03-10	U-2754		2022-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-002	9889118	2031-03-10	U-1744		2022-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-002	9084765	2034-02-26	U-1744		2022-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-002	9084765	2034-02-26	U-2754		2022-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-002	9084765	2034-02-26	U-3467		2022-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-002	11357753	2038-02-09	U-2754		2022-07-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-002	12005042	2038-02-09	U-3467		2025-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-002	12005042	2038-02-09	U-2754		2025-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-002	12005042	2038-02-09	U-1744		2025-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-002	12329740	2038-02-09	U-2754		2025-07-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-002	12329740	2038-02-09	U-3467		2025-07-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209510-001	10525033	2031-03-10		Drug product	2020-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209510-001	12194022	2031-03-10	U-1744		2025-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209510-001	12194022	2031-03-10	U-3467		2025-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209510-001	9545426	2031-03-10	U-1744		2020-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209510-001	9545426	2031-03-10	U-2754		2020-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209510-001	9889118	2031-03-10	U-2754		2020-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209510-001	9889118	2031-03-10	U-1744		2020-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209510-001	9084765	2034-02-26	U-1744		2020-03-16	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 64 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209510-001	NCE	2025-02-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209510-002	NCE	2025-02-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209510-001	NCE	2025-02-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209510-002	NCE	2025-02-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209510-001	NCE	2025-02-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209510-002	NCE	2025-02-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209510-001	NCE	2025-02-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209510-002	NCE	2025-02-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209510-001	NCE	2025-02-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209510-002	NCE	2025-02-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209510-001	NCE	2025-02-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209510-002	NCE	2025-02-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209510-001	NCE	2025-02-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209510-002	NCE	2025-02-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209510-001	NCE	2025-02-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209510-002	NCE	2025-02-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209510-001	NCE	2025-02-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209510-002	NCE	2025-02-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209510-001	NCE	2025-02-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209510-002	NCE	2025-02-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209510-001	NCE	2025-02-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209510-002	NCE	2025-02-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209510-001	NCE	2025-02-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209510-002	NCE	2025-02-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209510-001	NCE	2025-02-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209510-002	NCE	2025-02-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209510-001	NCE	2025-02-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209510-002	NCE	2025-02-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209510-001	NCE	2025-02-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209510-002	NCE	2025-02-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209510-001	NCE	2025-02-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209510-002	NCE	2025-02-26	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N209510-001	NCE	2025-02-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209510-001	NCE	2025-02-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209510-001	NCE	2025-02-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209510-001	NCE	2025-02-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209510-001	NCE	2025-02-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209510-001	NCE	2025-02-26	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209510-001	NCE	2025-02-26	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209510-002	NCE	2025-02-26	`6a51e52b5d6a…`

Additional Listing Data#

Finished product: Yes
Brand name base: Barhemsys

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMISULPRIDE	2.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8110R61I4U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2284232	Internal RxNorm lookup
2284237	Internal RxNorm lookup
2467148	Internal RxNorm lookup
2467149	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
ab23bc6e-b6a8-165f-e053-2a95a90ab144	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
48e67b77-b923-4109-bcbb-7697d716174b	Product name	1	20230905

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71390-125-20	Barhemsys	10 in 1 PACKAGE	INJECTION, SOLUTION	10	7
71390-125-21	Barhemsys	1 in 1 CARTON	INJECTION, SOLUTION	1	7
71390-125-21	Barhemsys	2 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	2	7
71390-125-50	Barhemsys	10 in 1 PACKAGE	INJECTION, SOLUTION	10	7
71390-125-51	Barhemsys	4 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	4	7
71390-125-51	Barhemsys	1 in 1 CARTON	INJECTION, SOLUTION	1	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71390-125-20	ML - Milliliter	71390-125	b7a95b81-f59d-4320-9c5e-1709a244787b	1	2020-09-14
71390-125-21	ML - Milliliter	71390-125	1ac6bb1d-226e-4ed7-a873-11e535f81cbc	1	2020-09-14
71390-125-50	ML - Milliliter	71390-125	c3404c97-ce54-4b94-b0d1-2dd9cfc4d427	1	2021-04-08
71390-125-51	ML - Milliliter	71390-125	5c94efd6-aa0f-44ec-91c1-f2071462a83a	1	2021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71390-125	BARHEMSYS (AMISULPRIDE) INJECTION, SOLUTION [ACACIA PHARMA LTD]	6	Current NDC, Legacy NDC, 6 package rows	20220929_ab23bc6e-b6a8-165f-e053-2a95a90ab144.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
Barhemsys	AMISULPRIDE	Acacia Pharma Ltd	ab23bc6e-b6a8-165f-e053-2a95a90ab144	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209510 application number: NDA209510 ndc (product): 71390-125

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8110R61I4U	AMISULPRIDE	71675-85-9	AMISULPRIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2467148	amisulpride 10 MG in 4 ML Injection	PSN	ab23bc6e-b6a8-165f-e053-2a95a90ab144	7
2284232	amisulpride 5 MG in 2 mL Injection	PSN	ab23bc6e-b6a8-165f-e053-2a95a90ab144	7
2467149	Barhemsys 10 MG in 4 ML Injection	PSN	ab23bc6e-b6a8-165f-e053-2a95a90ab144	7
2284237	Barhemsys 5 MG in 2 mL Injection	PSN	ab23bc6e-b6a8-165f-e053-2a95a90ab144	7
2284237	2 ML amisulpride 2.5 MG/ML Injection [Barhemsys]	SBD	ab23bc6e-b6a8-165f-e053-2a95a90ab144	7
2467149	4 ML amisulpride 2.5 MG/ML Injection [Barhemsys]	SBD	ab23bc6e-b6a8-165f-e053-2a95a90ab144	7
2284232	2 ML amisulpride 2.5 MG/ML Injection	SCD	ab23bc6e-b6a8-165f-e053-2a95a90ab144	7
2467148	4 ML amisulpride 2.5 MG/ML Injection	SCD	ab23bc6e-b6a8-165f-e053-2a95a90ab144	7
2467149	4 ML Barhemsys 2.5 MG/ML Injection	SY	ab23bc6e-b6a8-165f-e053-2a95a90ab144	7
2467148	amisulpride 10 MG per 4 ML Injection	SY	ab23bc6e-b6a8-165f-e053-2a95a90ab144	7
2284232	amisulpride 2.5 MG/ML per 2 ML Injection	SY	ab23bc6e-b6a8-165f-e053-2a95a90ab144	7
2467148	amisulpride 2.5 MG/ML per 4 ML Injection	SY	ab23bc6e-b6a8-165f-e053-2a95a90ab144	7
2284232	amisulpride 5 MG per 2 ML Injection	SY	ab23bc6e-b6a8-165f-e053-2a95a90ab144	7
2467149	Barhemsys 10 MG per 4 ML Injection	SY	ab23bc6e-b6a8-165f-e053-2a95a90ab144	7
2284237	Barhemsys 2.5 MG/ML per 2 ML Injection	SY	ab23bc6e-b6a8-165f-e053-2a95a90ab144	7
2467149	Barhemsys 2.5 MG/ML per 4 ML Injection	SY	ab23bc6e-b6a8-165f-e053-2a95a90ab144	7
2284237	Barhemsys 5 MG per 2 ML Injection	SY	ab23bc6e-b6a8-165f-e053-2a95a90ab144	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71390-125-20	71390012520	10 CARTON in 1 PACKAGE (71390-125-20) / 1 VIAL, SINGLE-DOSE in 1 CARTON (71390-125-21) / 2 mL in 1 VIAL, SINGLE-DOSE	10 carton	2020-02-27	0000-00-00	No	No	Current
71390-125-21	71390012521	1 in 1 CARTON						Historical
71390-125-50	71390012550	10 CARTON in 1 PACKAGE (71390-125-50) / 1 VIAL, SINGLE-DOSE in 1 CARTON (71390-125-51) / 4 mL in 1 VIAL, SINGLE-DOSE	10 carton	2020-02-27	0000-00-00	No	No	Current
71390-125-51	71390012551	4 mL in 1 VIAL, SINGLE-DOSE	4 ml					Historical