Dexmedetomidine Hydrochloride

Product NDC: 70069-759
11-digit product format: 700690759
Labeler code: 70069
Product ID: 70069-759_6a1a2c33-1467-4eb0-adc6-6e21771fbf6b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dexmedetomidine Hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Somerset Therapeutics, LLC
Application: ANDA218112
Marketing category: ANDA
Marketing start: 2024-09-26
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 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
A218112-001	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP		2024-09-24
A218112-002	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP		2024-09-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A218112-001	AP
A218112-002	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.

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	A218112-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-09-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A218112-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-09-24	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A218112-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-09-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218112-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-09-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218112-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-09-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218112-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-09-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218112-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218112-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218112-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218112-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218112-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218112-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218112-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218112-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218112-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218112-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218112-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-09-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218112-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218112-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-09-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218112-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-09-24	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218112-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-09-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218112-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218112-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-09-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A218112-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-09-24	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218112-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-09-24	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218112-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2024-09-24	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A218112-001	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A218112-002	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A218112-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218112-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218112-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218112-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218112-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218112-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218112-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218112-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218112-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218112-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218112-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218112-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218112-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218112-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218112-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218112-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218112-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218112-002	AP	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218112-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218112-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218112-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A218112-002	AP	1	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218112-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218112-002	AP	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218112-001	CGT	2025-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218112-002	CGT	2025-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218112-001	CGT	2025-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218112-002	CGT	2025-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218112-001	CGT	2025-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218112-002	CGT	2025-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218112-001	CGT	2025-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218112-002	CGT	2025-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218112-001	CGT	2025-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218112-002	CGT	2025-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218112-001	CGT	2025-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218112-002	CGT	2025-03-30	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218112-001	CGT	2025-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218112-002	CGT	2025-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218112-001	CGT	2025-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A218112-002	CGT	2025-03-30	`d06236e962d9…`

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: 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
1788947	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
649e777b-9b30-4f1e-9fb9-6bba57580976	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
70069-759-04	Dexmedetomidine Hydrochloride	4 in 1 CARTON	INJECTION, SOLUTION	4		5
70069-759-04	Dexmedetomidine Hydrochloride	10 mL in 1 VIAL	INJECTION, SOLUTION	10		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70069-759-04	ML - Milliliter	70069-759	62b2d05e-4703-4745-9217-6505c3a25424	1	2024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70069-759	DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [SOMERSET THERAPEUTICS, LLC]	5	Current NDC, 2 package rows	20240927_649e777b-9b30-4f1e-9fb9-6bba57580976.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 Hydrochloride	DEXMEDETOMIDINE HYDROCHLORIDE	Somerset Therapeutics, LLC	649e777b-9b30-4f1e-9fb9-6bba57580976	2024-09-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218112 application number: ANDA218112 ndc (product): 70069-759

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
1788947	dexmedeTOMIDine HCl 100 MCG/ML Injectable Solution	PSN	649e777b-9b30-4f1e-9fb9-6bba57580976	5
1788947	dexmedetomidine 0.1 MG/ML Injectable Solution	SCD	649e777b-9b30-4f1e-9fb9-6bba57580976	5
1788947	dexmedetomidine (as dexmedetomidine HCl) 100 MCG/ML Injectable Solution	SY	649e777b-9b30-4f1e-9fb9-6bba57580976	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70069-759-04	70069075904	4 VIAL in 1 CARTON (70069-759-04) / 10 mL in 1 VIAL	4 vial	2024-09-26	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dexmedetomidine Hydrochloride	Somerset Therapeutics, LLC \| Somerset Therapeutics Private Limited	2024-09-26	HUMAN PRESCRIPTION DRUG LABEL	5