Application 208129

Type: ANDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	No	No
002	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	No	No
003	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	No	No
004	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A208129-001	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29
A208129-002	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29
A208129-003	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A208129-001	AP
A208129-002	AP
A208129-003	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 4 · 126 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	A208129-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208129-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208129-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208129-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208129-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208129-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208129-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208129-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208129-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208129-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208129-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208129-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208129-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208129-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208129-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208129-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208129-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208129-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208129-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208129-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208129-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208129-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208129-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208129-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208129-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208129-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208129-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208129-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208129-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208129-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208129-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208129-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208129-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208129-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208129-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208129-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208129-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208129-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208129-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208129-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A208129-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208129-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208129-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208129-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208129-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208129-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208129-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208129-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208129-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208129-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208129-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208129-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208129-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208129-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208129-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208129-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208129-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208129-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208129-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208129-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208129-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208129-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208129-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208129-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208129-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208129-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208129-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208129-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208129-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208129-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208129-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208129-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208129-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208129-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208129-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208129-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208129-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208129-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208129-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208129-001	AP	1	`1e350fbaab3a…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A208129-001	PC	2019-11-30	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A208129-001	PC	2019-11-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208129-001	PC	2019-11-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208129-001	PC	2019-11-30	`ea99ee380514…`

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 2 · 28 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexmedetomidine Hydrochloride	DEXMEDETOMIDINE HYDROCHLORIDE	Piramal Critical Care Inc	c958aeb4-69ce-c3e2-e053-2a95a90a6d8d	2026-07-28	Warnings, Adverse reactions	Name fallback brand name: Dexmedetomidine Hydrochloride generic name: DEXMEDETOMIDINE HYDROCHLORIDE
Dexmedetomidine	DEXMEDETOMIDINE	Eugia US LLC	8c162541-986b-4b30-866c-b2631ba2c975	2026-07-20	Warnings, Adverse reactions	Name fallback brand name: Dexmedetomidine Hydrochloride
Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	92b7ddaa-e45a-4b64-a802-bb5df8771dd6	2026-06-17	Warnings, Adverse reactions	Name fallback generic name: DEXMEDETOMIDINE HYDROCHLORIDE
Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	4419162d-81d4-49bd-96de-1729440bdb74	2026-06-09	Warnings, Adverse reactions	Name fallback generic name: DEXMEDETOMIDINE HYDROCHLORIDE
Dexmedetomidine Hydrochloride	DEXMEDETOMIDINE HYDROCHLORIDE	Baxter Healthcare Corporation	7d057255-22a1-4b69-ad7c-7337fac8e993	2026-05-29	Warnings, Adverse reactions	Name fallback brand name: Dexmedetomidine Hydrochloride generic name: DEXMEDETOMIDINE HYDROCHLORIDE
Dexmedetomidine Hydrochloride	DEXMEDETOMIDINE HYDROCHLORIDE	Amneal Pharmaceuticals LLC	eb1ba463-ab42-4f49-9ebe-3ad5af108326	2026-05-28	Warnings, Adverse reactions	Name fallback brand name: Dexmedetomidine Hydrochloride generic name: DEXMEDETOMIDINE HYDROCHLORIDE
DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	CIVICA, INC.	1faf1ac8-ff9b-4ed9-b562-06dab971173a	2026-05-22	Warnings, Adverse reactions	Name fallback brand name: DEXMEDETOMIDINE HYDROCHLORIDE generic name: DEXMEDETOMIDINE HYDROCHLORIDE
PRECEDEX	DEXMEDETOMIDINE HYDROCHLORIDE	Henry Schein, Inc.	9eb336de-5fa5-4b46-b40b-a7ca5a0864bd	2026-05-21	Warnings, Adverse reactions	Name fallback generic name: DEXMEDETOMIDINE HYDROCHLORIDE
Dexmedetomidine Hydrochloride	DEXMEDETOMIDINE HYDROCHLORIDE	Gland Pharma Limited	f307de7e-a9ab-4734-abb7-66b4e112bc51	2026-05-20	Warnings, Adverse reactions	Name fallback brand name: Dexmedetomidine Hydrochloride generic name: DEXMEDETOMIDINE HYDROCHLORIDE
Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	548a88c0-afda-427e-75ac-5af0cfa2224c	2026-05-20	Warnings, Adverse reactions	Name fallback generic name: DEXMEDETOMIDINE HYDROCHLORIDE
DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	Mylan Institutional LLC	f140de5a-f13d-46b4-a742-049c63e474f5	2026-05-20	Warnings, Adverse reactions	Name fallback brand name: DEXMEDETOMIDINE HYDROCHLORIDE generic name: DEXMEDETOMIDINE HYDROCHLORIDE
Dexmedetomidine Hydrochloride	DEXMEDETOMIDINE HYDROCHLORIDE IN SODIUM CHLORIDE	Amneal Pharmaceuticals LLC	4df8cc35-fc80-4438-b982-9c4b7d17bad2	2026-05-19	Warnings, Adverse reactions	Name fallback brand name: Dexmedetomidine Hydrochloride
Dexmedetomidine Hydrochloride	DEXMEDETOMIDINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	ca67b379-f8b3-4d35-bf8a-235ecd4c4211	2026-03-04	Warnings, Adverse reactions	Name fallback brand name: Dexmedetomidine Hydrochloride generic name: DEXMEDETOMIDINE HYDROCHLORIDE
Dexmedetomidine Hydrochloride	DEXMEDETOMIDINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	1896a96e-25f8-494e-9a96-6463b52fb102	2026-01-23	Warnings, Adverse reactions	Name fallback brand name: Dexmedetomidine Hydrochloride generic name: DEXMEDETOMIDINE HYDROCHLORIDE
DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	Baxter Healthcare Company	8ccb45a7-8290-469c-9644-a4dca967d88f	2025-12-26	Warnings, Adverse reactions	Name fallback brand name: DEXMEDETOMIDINE HYDROCHLORIDE generic name: DEXMEDETOMIDINE HYDROCHLORIDE
DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	Baxter Healthcare Company	32242f34-6e2b-4098-bd8e-3d55162f31b5	2025-12-19	Warnings, Adverse reactions	Name fallback brand name: DEXMEDETOMIDINE HYDROCHLORIDE generic name: DEXMEDETOMIDINE HYDROCHLORIDE
Dexmedetomidine Hydrochloride in Sodium Chloride	DEXMEDETOMIDINE HYDROCHLORIDE	Precision Dose, Inc.	e9d5c989-ebf6-4377-9c6e-7aef848a03a1	2025-12-15	Warnings, Adverse reactions	Name fallback generic name: DEXMEDETOMIDINE HYDROCHLORIDE
Dexmedetomidine Hydrochloride	DEXMEDETOMIDINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	c1b8eb58-596b-481d-beb6-ba9d2237abf4	2025-09-22	Warnings, Adverse reactions	Name fallback brand name: Dexmedetomidine Hydrochloride generic name: DEXMEDETOMIDINE HYDROCHLORIDE
Dexmedetomidine Hydrochloride	DEXMEDETOMIDINE HYDROCHLORIDE	Sagent Pharmaceuticals	65885aef-faaf-4dec-a180-9a657f738bbc	2025-06-26	Warnings, Adverse reactions	Name fallback brand name: Dexmedetomidine Hydrochloride generic name: DEXMEDETOMIDINE HYDROCHLORIDE
Dexmedetomidine Hydrochloride	DEXMEDETOMIDINE HYDROCHLORIDE	Somerset Therapeutics, LLC	649e777b-9b30-4f1e-9fb9-6bba57580976	2024-09-26	Warnings, Adverse reactions	Name fallback brand name: Dexmedetomidine Hydrochloride generic name: DEXMEDETOMIDINE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63323-671	Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride	Fresenius Kabi USA, LLC	ANDA	Current
63323-671	Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride	Fresenius Kabi USA, LLC	ANDA	Current
63323-671	Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride	Fresenius Kabi USA, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
53617	ORIG	2018-12-20