Dexmedetomidine

Product NDC: 44567-601
11-digit product format: 445670601
Labeler code: 44567
Product ID: 44567-601_39d2f5dc-b34e-4c4b-9c54-3c8fb2c20589
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dexmedetomidine
Dosage form: INJECTION, SOLUTION, CONCENTRATE
Route: INTRAVENOUS
Labeler: WG Critical Care, LLC
Application: NDA206628
Marketing category: NDA
Marketing start: 2016-04-19
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N206628-001	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2015-10-21
N206628-002	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2015-10-21
N206628-003	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22
N206628-004	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N206628-001	AP
N206628-002	AP

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N206628-003	9649296	2036-04-20	Drug product	2018-06-26
N206628-003	9717796	2036-04-20	Drug product	2018-06-26
N206628-004	9649296	2036-04-20	Drug product	2018-06-26
N206628-004	9717796	2036-04-20	Drug product	2018-06-26

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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N206628-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2015-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206628-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2015-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206628-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206628-004	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206628-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2015-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206628-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2015-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206628-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206628-004	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206628-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2015-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206628-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2015-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206628-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206628-004	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206628-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2015-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206628-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2015-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206628-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206628-004	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206628-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2015-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206628-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2015-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206628-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206628-004	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206628-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2015-10-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206628-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2015-10-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206628-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206628-004	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206628-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2015-10-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206628-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2015-10-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206628-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206628-004	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206628-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2015-10-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206628-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-10-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206628-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206628-004	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206628-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2015-10-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206628-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2015-10-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206628-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206628-004	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206628-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2015-10-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206628-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2015-10-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206628-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206628-004	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`d06236e962d9…`

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	N206628-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206628-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206628-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206628-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206628-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206628-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206628-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206628-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206628-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206628-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206628-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206628-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206628-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206628-002	AP	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206628-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206628-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206628-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206628-002	AP	1	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N206628-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N206628-002	AP	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N206628-003	9649296	2036-04-20	Drug product	2018-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206628-003	9717796	2036-04-20	Drug product	2018-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206628-004	9649296	2036-04-20	Drug product	2018-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206628-004	9717796	2036-04-20	Drug product	2018-06-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206628-003	9649296	2036-04-20	Drug product	2018-06-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206628-003	9717796	2036-04-20	Drug product	2018-06-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206628-004	9649296	2036-04-20	Drug product	2018-06-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206628-004	9717796	2036-04-20	Drug product	2018-06-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206628-003	9649296	2036-04-20	Drug product	2018-06-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206628-003	9717796	2036-04-20	Drug product	2018-06-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206628-004	9649296	2036-04-20	Drug product	2018-06-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206628-004	9717796	2036-04-20	Drug product	2018-06-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206628-003	9649296	2036-04-20	Drug product	2018-06-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206628-003	9717796	2036-04-20	Drug product	2018-06-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206628-004	9649296	2036-04-20	Drug product	2018-06-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206628-004	9717796	2036-04-20	Drug product	2018-06-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206628-003	9649296	2036-04-20	Drug product	2018-06-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206628-003	9717796	2036-04-20	Drug product	2018-06-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206628-004	9649296	2036-04-20	Drug product	2018-06-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206628-004	9717796	2036-04-20	Drug product	2018-06-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206628-003	9649296	2036-04-20	Drug product	2018-06-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206628-003	9717796	2036-04-20	Drug product	2018-06-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206628-004	9649296	2036-04-20	Drug product	2018-06-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206628-004	9717796	2036-04-20	Drug product	2018-06-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206628-003	9649296	2036-04-20	Drug product	2018-06-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206628-003	9717796	2036-04-20	Drug product	2018-06-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206628-004	9649296	2036-04-20	Drug product	2018-06-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206628-004	9717796	2036-04-20	Drug product	2018-06-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206628-003	9649296	2036-04-20	Drug product	2018-06-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206628-003	9717796	2036-04-20	Drug product	2018-06-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206628-004	9649296	2036-04-20	Drug product	2018-06-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206628-004	9717796	2036-04-20	Drug product	2018-06-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206628-003	9649296	2036-04-20	Drug product	2018-06-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206628-003	9717796	2036-04-20	Drug product	2018-06-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206628-004	9649296	2036-04-20	Drug product	2018-06-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206628-004	9717796	2036-04-20	Drug product	2018-06-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206628-003	9649296	2036-04-20	Drug product	2018-06-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206628-003	9717796	2036-04-20	Drug product	2018-06-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206628-004	9649296	2036-04-20	Drug product	2018-06-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206628-004	9717796	2036-04-20	Drug product	2018-06-26	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Dexmedetomidine
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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1718906	Internal RxNorm lookup
1718909	Internal RxNorm lookup
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
0d2710f2-ee47-4114-ab5c-8dca74cdcb8d	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
44567-601-04	Dexmedetomidine	10 mL in 1 VIAL	INJECTION, SOLUTION, CONCENTRATE	10		13
44567-601-04	Dexmedetomidine	4 in 1 CARTON	INJECTION, SOLUTION, CONCENTRATE	4		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
44567-601-04	ML - Milliliter	44567-601	18a4e852-87d1-45fd-92a9-cb1dcd55353e	1	2016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
44567-601	DEXMEDETOMIDINE INJECTION, SOLUTION, CONCENTRATE DEXMEDETOMIDINE IN DEXTROSE (DEXMEDETOMIDINE) INJECTION [WG CRITICAL CARE, LLC]	8	Current NDC, Legacy NDC, 2 package rows	20250315_0d2710f2-ee47-4114-ab5c-8dca74cdcb8d.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	WG Critical Care, LLC	0d2710f2-ee47-4114-ab5c-8dca74cdcb8d	2026-06-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 206628 application number: NDA206628 ndc (product): 44567-601

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
44567-601-04	44567060104	4 VIAL in 1 CARTON (44567-601-04) / 10 mL in 1 VIAL	4 vial	2017-01-26	0000-00-00	No	No	Current