DEXMEDETOMIDINE HYDROCHLORIDE

Product NDC: 0338-9555
11-digit product format: 003389555
Labeler code: 0338
Product ID: 0338-9555_956f6a8c-cbb8-45de-9828-67f1ed7ab4e7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DEXMEDETOMIDINE HYDROCHLORIDE
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Baxter Healthcare Company
Application: ANDA208532
Marketing category: ANDA
Marketing start: 2018-08-21
Substance: DEXMEDETOMIDINE HYDROCHLORIDE
Active strength: 200 ug/50mL
Pharmacologic classes: Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A208532-001	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP		2018-08-21
A208532-002	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP		2018-08-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208532-001	AP
A208532-002	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 · 88 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
2026-10-15 13:18:30	2026-09	A208532-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A208532-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-21	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A208532-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208532-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208532-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208532-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208532-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208532-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208532-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208532-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208532-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208532-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208532-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208532-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208532-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208532-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208532-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208532-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208532-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208532-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208532-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208532-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208532-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208532-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208532-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208532-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208532-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208532-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208532-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208532-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208532-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208532-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208532-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208532-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208532-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208532-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208532-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208532-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208532-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208532-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-21	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A208532-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208532-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208532-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208532-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208532-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208532-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208532-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208532-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208532-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A208532-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208532-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A208532-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208532-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A208532-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208532-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A208532-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208532-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A208532-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208532-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A208532-002	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208532-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208532-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208532-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A208532-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208532-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A208532-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208532-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208532-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208532-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208532-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208532-001	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208532-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208532-001	AP	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208532-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208532-001	AP	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A208532-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208532-001	AP	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A208532-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208532-001	AP	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208532-002	AP	1	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: DEXMEDETOMIDINE HYDROCHLORIDE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXMEDETOMIDINE HYDROCHLORIDE	200 ug/50mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4ec136f1-cd53-4b90-826e-3eaeec54dca0	Product name	2	20250401
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
acae4bed-c293-9f7e-61b9-d68b8475ed3a	Product name	2	20230104
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
536fa340-f745-6c4e-1ad7-a3c414722bcc	Product name	9	20170706
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0338-9555-24	DEXMEDETOMIDINE HYDROCHLORIDE	50 mL in 1 BAG	INJECTION	50		13
0338-9555-24	DEXMEDETOMIDINE HYDROCHLORIDE	24 in 1 CARTON	INJECTION	24		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0338-9555-24	ML - Milliliter	0338-9555	4487451b-60b8-407b-a699-8b265e25567f	1	2018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0338-9555	DEXMEDETOMIDINE HYDROCHLORIDE INJECTION [BAXTER HEALTHCARE COMPANY]	12	Current NDC, Legacy NDC, 2 package rows	20250516_8ccb45a7-8290-469c-9644-a4dca967d88f.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1018WH7F9I	DEXMEDETOMIDINE HYDROCHLORIDE	145108-58-3	DEXMEDETOMIDINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1718906	dexmedeTOMIDine HCl 200 MCG in 50 ML Injection	PSN	8ccb45a7-8290-469c-9644-a4dca967d88f	13
1718909	dexmedeTOMIDine HCl 400 MCG in 100 ML Injection	PSN	8ccb45a7-8290-469c-9644-a4dca967d88f	13
1718909	100 ML dexmedetomidine 0.004 MG/ML Injection	SCD	8ccb45a7-8290-469c-9644-a4dca967d88f	13
1718906	50 ML dexmedetomidine 0.004 MG/ML Injection	SCD	8ccb45a7-8290-469c-9644-a4dca967d88f	13
1718906	dexmedetomidine (as dexmedetomidine HCl) 200 MCG per 50 ML Injection	SY	8ccb45a7-8290-469c-9644-a4dca967d88f	13
1718909	dexmedetomidine (as dexmedetomidine HCl) 400 MCG per 100 ML Injection	SY	8ccb45a7-8290-469c-9644-a4dca967d88f	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0338-9555-24	00338955524	24 BAG in 1 CARTON (0338-9555-24) / 50 mL in 1 BAG	24 bag	2018-08-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DEXMEDETOMIDINE HYDROCHLORIDE	Baxter Healthcare Company \| Baxter Healthcare Corporation	2026-07-02	HUMAN PRESCRIPTION DRUG LABEL	14