DEXMEDETOMIDINE

Product NDC: 84549-505
11-digit product format: 845490505
Labeler code: 84549
Product ID: 84549-505_42dab90e-68c2-bed1-e063-6294a90a4b0c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DEXMEDETOMIDINE
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: ProPharma Distribution
Application: ANDA204843
Marketing category: ANDA
Marketing start: 2019-01-18
Substance: DEXMEDETOMIDINE HYDROCHLORIDE
Active strength: 100 ug/mL
Pharmacologic classes: Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A204843-001	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP		2019-01-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204843-001	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 2 · 41 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
2026-02-19 14:30 UTC	2026-02	A204843-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-01-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204843-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-01-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204843-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-01-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204843-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-01-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204843-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-01-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204843-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-01-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204843-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-01-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204843-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-01-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204843-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-01-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204843-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-01-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204843-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-01-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204843-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-01-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204843-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-01-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204843-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-01-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204843-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-01-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204843-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-01-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204843-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-01-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204843-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION		2019-01-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204843-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-01-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204843-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-01-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204843-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION		2019-01-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204843-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION		2019-01-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204843-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION		2019-01-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204843-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION		2019-01-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204843-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION		2019-01-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204843-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION		2019-01-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204843-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-01-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204843-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-01-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204843-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-01-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204843-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-01-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204843-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-01-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204843-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-01-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204843-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-01-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204843-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-01-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204843-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-01-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204843-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-01-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204843-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-01-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204843-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-01-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204843-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-01-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204843-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-01-18	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204843-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204843-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204843-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204843-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204843-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204843-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204843-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204843-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204843-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204843-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204843-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204843-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204843-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204843-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204843-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204843-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204843-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A204843-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204843-001	AP	1	`782e0a99824c…`
2019-07-19 19:46 UTC	2019-07	A204843-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204843-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204843-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204843-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204843-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204843-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204843-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204843-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204843-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204843-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204843-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204843-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204843-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204843-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A204843-001	AP	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: DEXMEDETOMIDINE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXMEDETOMIDINE HYDROCHLORIDE	100 ug/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1018WH7F9I	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
309710	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
42dab90e-68c1-bed1-e063-6294a90a4b0c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4ec136f1-cd53-4b90-826e-3eaeec54dca0	Product name	2	20250401
acae4bed-c293-9f7e-61b9-d68b8475ed3a	Product name	2	20230104
536fa340-f745-6c4e-1ad7-a3c414722bcc	Product name	9	20170706

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
84549-505-03	DEXMEDETOMIDINE	2 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	2		1

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DEXMEDETOMIDINE	DEXMEDETOMIDINE	Meitheal Pharmaceuticals Inc.	8fa36783-b94d-4084-8c41-40ee64192074	2026-08-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204843 application number: ANDA204843
DEXMEDETOMIDINE	DEXMEDETOMIDINE	ProPharma Distribution	42dab90e-68c1-bed1-e063-6294a90a4b0c	2025-11-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204843 application number: ANDA204843 ndc (product): 84549-505

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1018WH7F9I	DEXMEDETOMIDINE HYDROCHLORIDE	145108-58-3	DEXMEDETOMIDINE HYDROCHLORIDE
67VB76HONO	DEXMEDETOMIDINE	113775-47-6	DEXMEDETOMIDINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309710	dexmedeTOMIDine HCl 200 MCG in 2 ML Injection	PSN	42dab90e-68c1-bed1-e063-6294a90a4b0c	1
309710	2 ML dexmedetomidine 0.1 MG/ML Injection	SCD	42dab90e-68c1-bed1-e063-6294a90a4b0c	1
309710	dexmedetomidine (as dexmedetomidine HCl) 0.1 MG/ML per 2 ML Injection	SY	42dab90e-68c1-bed1-e063-6294a90a4b0c	1
309710	dexmedetomidine (as dexmedetomidine HCl) 100 MCG/ML Injection	SY	42dab90e-68c1-bed1-e063-6294a90a4b0c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
84549-505-03	84549050503	2 mL in 1 VIAL, SINGLE-DOSE (84549-505-03)	2 ml	2025-10-10	No	No	Current