Dexmedetomidine Hydrochloride

Product NDC: 63323-421
11-digit product format: 633230421
Labeler code: 63323
Product ID: 63323-421_56e0af34-aeb5-4b37-8c61-2e90b2c8ca6c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dexmedetomidine hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
Application: ANDA201072
Marketing category: ANDA
Marketing start: 2015-09-18
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: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63323-421		D	Discontinued by firm		2026-10-12
excluded package	package	63323-421	63323-421-16	D	Discontinued by firm		2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63323-421-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63323-421-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63323-421-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63323-421-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63323-421-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63323-421-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63323-421-16	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63323-421-16	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63323-421-16	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63323-421-16	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63323-421-16	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63323-421-16	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A201072-001	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP		2015-09-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201072-001	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 2 of 2 · 43 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
2022-09-29 23:25 UTC	2022-09	A201072-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2015-09-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201072-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2015-09-18	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A201072-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2015-09-18	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A201072-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201072-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201072-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201072-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201072-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201072-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201072-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201072-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201072-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201072-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201072-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201072-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201072-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201072-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201072-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201072-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201072-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201072-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201072-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201072-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201072-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201072-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201072-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201072-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201072-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201072-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201072-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201072-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201072-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201072-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201072-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201072-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201072-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201072-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201072-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201072-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201072-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201072-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201072-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201072-001	AP	1	`f41ea6bd6efb…`

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	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
c1b8eb58-596b-481d-beb6-ba9d2237abf4	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
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
63323-421-01	Dexmedetomidine Hydrochloride	2 mL in 1 VIAL	INJECTION, SOLUTION	2		9
63323-421-02	Dexmedetomidine Hydrochloride	25 in 1 TRAY	INJECTION, SOLUTION	25		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-421-01	ML - Milliliter	63323-421	5be31c1c-261b-4fad-adc2-48c92f3e5d18	1	2024-04-05
63323-421-02	ML - Milliliter	63323-421	fe5184cd-2d05-4b8d-942b-eb45f5d8273c	1	2015-12-02
63323-421-16	ML - Milliliter	63323-421	1270b335-9970-468c-8a10-dd716c0f16af	1	2016-05-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXMEDETOMIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	1018WH7F9I	DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
DEXMEDETOMIDINE	ACTIVE MOIETY	67VB76HONO	DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
ACETIC ACID	INACTIVE INGREDIENT	Q40Q9N063P	DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
SODIUM ACETATE	INACTIVE INGREDIENT	4550K0SC9B	DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-421	DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]	8	Current NDC, Legacy NDC, 2 package rows	20221123_c1b8eb58-596b-481d-beb6-ba9d2237abf4.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexmedetomidine Hydrochloride	DEXMEDETOMIDINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	1896a96e-25f8-494e-9a96-6463b52fb102	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201072 application number: ANDA201072
Dexmedetomidine Hydrochloride	DEXMEDETOMIDINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	c1b8eb58-596b-481d-beb6-ba9d2237abf4	2025-09-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201072 application number: ANDA201072 ndc (product): 63323-421

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
309710	dexmedeTOMIDine HCl 200 MCG in 2 ML Injection	PSN	c1b8eb58-596b-481d-beb6-ba9d2237abf4	9
309710	2 ML dexmedetomidine 0.1 MG/ML Injection	SCD	c1b8eb58-596b-481d-beb6-ba9d2237abf4	9
309710	dexmedetomidine (as dexmedetomidine HCl) 0.1 MG/ML per 2 ML Injection	SY	c1b8eb58-596b-481d-beb6-ba9d2237abf4	9
309710	dexmedetomidine (as dexmedetomidine HCl) 100 MCG/ML Injection	SY	c1b8eb58-596b-481d-beb6-ba9d2237abf4	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-421-01	63323042101	2 mL in 1 VIAL	2 ml					Historical
63323-421-02	63323042102	25 VIAL in 1 TRAY (63323-421-02) / 2 mL in 1 VIAL (63323-421-01)	25 vial	2015-09-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dexmedetomidine Hydrochloride	Fresenius Kabi USA, LLC	2025-09-22	HUMAN PRESCRIPTION DRUG LABEL	9
Dexmedetomidine Hydrochloride	Fresenius Kabi USA, LLC	2020-01-22	Human Prescription Drug Label	4