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 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
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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N209510-001	BARHEMSYS	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-02-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209510-002	BARHEMSYS	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-09-01	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N209510-001	10525033	2031-03-10		Drug product	2020-03-16	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209510-001	12194022	2031-03-10	U-1744		2025-01-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209510-001	12194022	2031-03-10	U-3467		2025-01-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209510-001	9545426	2031-03-10	U-1744		2020-03-16	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209510-001	9545426	2031-03-10	U-2754		2020-03-16	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209510-001	9889118	2031-03-10	U-2754		2020-03-16	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209510-001	9889118	2031-03-10	U-1744		2020-03-16	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209510-001	9084765	2034-02-26	U-1744		2020-03-16	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209510-001	9084765	2034-02-26	U-2754		2020-03-16	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209510-001	9084765	2034-02-26	U-3467		2020-03-16	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209510-001	11357753	2038-02-09	U-2754		2022-07-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209510-001	12005042	2038-02-09	U-1744		2025-01-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209510-001	12005042	2038-02-09	U-3467		2025-01-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209510-001	12005042	2038-02-09	U-2754		2025-01-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209510-001	12329740	2038-02-09	U-2754		2025-07-02	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209510-001	12329740	2038-02-09	U-3467		2025-07-02	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209510-002	10525033	2031-03-10		Drug product	2022-02-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209510-002	12194022	2031-03-10	U-1744		2025-01-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209510-002	12194022	2031-03-10	U-3467		2025-01-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209510-002	9545426	2031-03-10	U-2754		2022-02-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209510-002	9545426	2031-03-10	U-1744		2022-02-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209510-002	9889118	2031-03-10	U-2754		2022-02-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209510-002	9889118	2031-03-10	U-1744		2022-02-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209510-002	9084765	2034-02-26	U-1744		2022-02-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209510-002	9084765	2034-02-26	U-2754		2022-02-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209510-002	9084765	2034-02-26	U-3467		2022-02-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209510-002	11357753	2038-02-09	U-2754		2022-07-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209510-002	12005042	2038-02-09	U-3467		2025-01-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209510-002	12005042	2038-02-09	U-2754		2025-01-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209510-002	12005042	2038-02-09	U-1744		2025-01-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209510-002	12329740	2038-02-09	U-2754		2025-07-02	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209510-002	12329740	2038-02-09	U-3467		2025-07-02	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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

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