Dexmedetomidine

Product NDC: 17478-055
11-digit product format: 174780055
Labeler code: 17478
Product ID: 17478-055_70df3506-5cb1-4f18-9b0e-ebbdc4955b86
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dexmedetomidine Hydrochloride
Dosage form: INJECTION, SOLUTION, CONCENTRATE
Route: INTRAVENOUS
Labeler: Akorn
Application: ANDA202585
Marketing category: ANDA
Marketing start: 2014-11-24
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

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	17478-055		I	Inactivated by FDA		2026-10-05
excluded package	package	17478-055	17478-055-02	I	Inactivated by FDA		2026-10-05

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 · 30 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	17478-055-02	`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	17478-055-02	`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	17478-055-02	`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	17478-055-02	`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	17478-055-02	`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	17478-055-02	`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	17478-055-02	`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	17478-055-02	`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	17478-055-02	`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	17478-055-02	`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	17478-055-02	`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	17478-055-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	17478-055-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	17478-055-02	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	17478-055-02	`1332a3947898…`	`d4bfe170f9cd…`

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
A202585-001	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP		2014-11-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202585-001	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 · 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
2026-09-14 22:38:34	2026-08	A202585-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2014-11-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202585-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2014-11-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202585-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2014-11-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202585-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2014-11-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202585-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2014-11-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202585-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2014-11-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202585-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2014-11-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202585-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2014-11-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202585-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2014-11-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202585-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2014-11-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202585-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2014-11-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202585-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2014-11-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202585-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2014-11-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202585-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2014-11-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202585-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2014-11-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202585-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2014-11-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202585-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2014-11-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202585-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2014-11-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202585-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2014-11-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202585-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2014-11-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202585-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2014-11-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202585-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2014-11-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202585-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2014-11-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202585-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2014-11-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202585-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2014-11-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202585-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2014-11-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202585-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2014-11-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202585-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2014-11-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202585-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2014-11-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202585-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2014-11-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202585-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2014-11-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202585-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2014-11-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202585-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2014-11-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202585-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2014-11-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202585-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2014-11-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202585-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2014-11-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202585-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2014-11-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202585-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2014-11-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202585-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2014-11-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202585-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2014-11-24	`f41ea6bd6efb…`

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	A202585-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202585-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202585-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202585-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202585-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202585-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202585-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202585-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202585-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202585-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202585-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202585-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202585-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202585-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202585-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202585-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202585-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202585-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202585-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202585-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202585-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202585-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202585-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202585-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202585-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202585-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202585-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202585-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202585-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202585-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202585-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202585-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202585-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202585-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202585-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202585-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202585-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202585-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202585-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202585-001	AP	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17478-055-02	2024-01-30	C162847	48780-1	1030e365-5c50-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use DEXMEDETOMIDINE HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE HYDROCHLORIDE INJECTION. DEXMEDETOMIDINE HYDROCHLORIDE Injection, for intravenous use Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
17478-055-02	Dexmedetomidine	10 in 1 CARTON	INJECTION, SOLUTION, CONCENTRATE	10		8
17478-055-02	Dexmedetomidine	2 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION, CONCENTRATE	2		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17478-055-02	ML - Milliliter	17478-055	149fbc8b-602d-415b-a9e8-20492f78efc5	1	2015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Dexmedetomidine Hydrochloride	ACTIVE INGREDIENT	1018WH7F9I	DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [AKORN, INC. ]	1
Dexmedetomidine	ACTIVE MOIETY	67VB76HONO	DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [AKORN, INC. ]	1
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [AKORN, INC. ]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [AKORN, INC. ]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17478-055	DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [AKORN]	8	Legacy NDC, 2 package rows	20221027_8fb7886c-7762-4b72-989b-0fe8e963b4b8.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
309710	dexmedeTOMIDine HCl 200 MCG in 2 ML Injection	PSN	8fb7886c-7762-4b72-989b-0fe8e963b4b8	8
309710	2 ML dexmedetomidine 0.1 MG/ML Injection	SCD	8fb7886c-7762-4b72-989b-0fe8e963b4b8	8
309710	dexmedetomidine (as dexmedetomidine HCl) 0.1 MG/ML per 2 ML Injection	SY	8fb7886c-7762-4b72-989b-0fe8e963b4b8	8
309710	dexmedetomidine (as dexmedetomidine HCl) 100 MCG/ML Injection	SY	8fb7886c-7762-4b72-989b-0fe8e963b4b8	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
17478-055-02	17478005502	10 VIAL, SINGLE-DOSE in 1 CARTON (17478-055-02) > 2 mL in 1 VIAL, SINGLE-DOSE	2014-11-24	0000-00-00	No	No	Current