Dexmedetomidine Hydrochloride

Product NDC: 55150-297
11-digit product format: 551500297
Labeler code: 55150
Product ID: 55150-297_b08abc07-bacd-453d-b6c3-cb6fa9eff79b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Eugia US LLC
Application: ANDA210321
Marketing category: ANDA
Marketing start: 2020-12-07
Substance: DEXMEDETOMIDINE HYDROCHLORIDE
Active strength: 4 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

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

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
A210321-001	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP		2020-12-07
A210321-002	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP		2020-12-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210321-001	AP
A210321-002	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 2 · 74 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	A210321-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-12-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210321-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-12-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210321-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210321-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-12-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210321-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210321-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-12-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210321-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210321-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-12-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210321-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-12-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210321-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-12-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210321-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-12-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210321-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-12-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210321-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210321-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-12-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210321-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-12-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210321-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-12-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210321-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-12-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210321-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-12-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210321-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-12-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210321-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-12-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210321-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-12-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210321-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-12-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210321-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-12-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210321-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-12-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210321-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-12-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210321-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-12-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210321-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-12-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210321-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-12-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210321-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-12-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210321-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-12-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210321-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-12-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210321-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-12-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210321-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-12-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210321-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-12-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210321-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-12-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210321-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-12-07	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210321-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-12-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210321-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-12-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210321-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-12-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210321-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-12-07	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 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	A210321-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210321-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210321-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210321-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210321-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210321-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210321-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210321-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210321-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210321-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210321-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210321-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210321-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210321-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210321-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210321-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210321-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210321-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210321-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210321-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210321-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210321-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210321-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210321-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210321-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210321-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210321-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210321-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210321-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210321-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210321-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210321-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210321-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210321-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210321-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210321-002	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210321-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210321-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210321-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210321-002	AP	1	`782e0a99824c…`

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	4 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
309710	Internal RxNorm lookup
1718906	Internal RxNorm lookup
1718909	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
8c162541-986b-4b30-866c-b2631ba2c975	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
55150-297-10	Dexmedetomidine Hydrochloride	1 in 1 POUCH	INJECTION, SOLUTION	1		15
55150-297-10	Dexmedetomidine Hydrochloride	10 in 1 CARTON	INJECTION, SOLUTION	10		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55150-297-10	ML - Milliliter	55150-297	e4edabec-036d-485f-bc99-b3161c1fba61	1	2021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55150-297	DEXMEDETOMIDINE INJECTION, SOLUTION DEXMEDETOMIDINE HYDROCHLORIDE (DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE) INJECTION, SOLUTION [EUGIA US LLC]	12	Current NDC, Legacy NDC, 2 package rows	20230608_8c162541-986b-4b30-866c-b2631ba2c975.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexmedetomidine	DEXMEDETOMIDINE	Eugia US LLC	8c162541-986b-4b30-866c-b2631ba2c975	2026-07-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210321 application number: ANDA210321 ndc (product): 55150-297

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	8c162541-986b-4b30-866c-b2631ba2c975	15
1718906	dexmedeTOMIDine HCl 200 MCG in 50 ML Injection	PSN	8c162541-986b-4b30-866c-b2631ba2c975	15
1718909	dexmedeTOMIDine HCl 400 MCG in 100 ML Injection	PSN	8c162541-986b-4b30-866c-b2631ba2c975	15
1718909	100 ML dexmedetomidine 0.004 MG/ML Injection	SCD	8c162541-986b-4b30-866c-b2631ba2c975	15
309710	2 ML dexmedetomidine 0.1 MG/ML Injection	SCD	8c162541-986b-4b30-866c-b2631ba2c975	15
1718906	50 ML dexmedetomidine 0.004 MG/ML Injection	SCD	8c162541-986b-4b30-866c-b2631ba2c975	15
309710	dexmedetomidine (as dexmedetomidine HCl) 0.1 MG/ML per 2 ML Injection	SY	8c162541-986b-4b30-866c-b2631ba2c975	15
309710	dexmedetomidine (as dexmedetomidine HCl) 100 MCG/ML Injection	SY	8c162541-986b-4b30-866c-b2631ba2c975	15
1718906	dexmedetomidine (as dexmedetomidine HCl) 200 MCG per 50 ML Injection	SY	8c162541-986b-4b30-866c-b2631ba2c975	15
1718909	dexmedetomidine (as dexmedetomidine HCl) 400 MCG per 100 ML Injection	SY	8c162541-986b-4b30-866c-b2631ba2c975	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55150-297-10	55150029710	10 POUCH in 1 CARTON (55150-297-10) / 1 BAG in 1 POUCH / 100 mL in 1 BAG	10 pouch	2020-12-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dexmedetomidine	Eugia US LLC \| EUGIA PHARMA SPECIALITIES LIMITED	2026-07-20	Human Prescription Drug Label	16
Dexmedetomidine Hydrochloride	AuroMedics Pharma LLC \| Aurobindo Pharma Limited	2020-09-02	Human Prescription Drug Label	1