Dexmedetomidine in Dextrose

Product NDC: 44567-602
11-digit product format: 445670602
Labeler code: 44567
Product ID: 44567-602_ee503974-3f79-46d7-845f-2d15444dc0b8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dexmedetomidine
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: WG Critical Care, LLC
Application: NDA206628
Marketing category: NDA
Marketing start: 2016-04-19
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 44.

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 · 176 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
2026-10-15 13:18:30	2026-09	N206628-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2015-10-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206628-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2015-10-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206628-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206628-004	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N206628-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2015-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206628-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2015-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206628-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206628-004	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N206628-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2015-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206628-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2015-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206628-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206628-004	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`caaa826d4ba7…`
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…`

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	N206628-001	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206628-002	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N206628-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206628-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N206628-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206628-002	AP	1	`caaa826d4ba7…`
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 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N206628-003	9649296	2036-04-20	Drug product	2018-06-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206628-003	9717796	2036-04-20	Drug product	2018-06-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206628-004	9649296	2036-04-20	Drug product	2018-06-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206628-004	9717796	2036-04-20	Drug product	2018-06-26	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N206628-003	9649296	2036-04-20	Drug product	2018-06-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206628-003	9717796	2036-04-20	Drug product	2018-06-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206628-004	9649296	2036-04-20	Drug product	2018-06-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206628-004	9717796	2036-04-20	Drug product	2018-06-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N206628-003	9649296	2036-04-20	Drug product	2018-06-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206628-003	9717796	2036-04-20	Drug product	2018-06-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206628-004	9649296	2036-04-20	Drug product	2018-06-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206628-004	9717796	2036-04-20	Drug product	2018-06-26	`caaa826d4ba7…`
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…`

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 in Dextrose
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXMEDETOMIDINE HYDROCHLORIDE	4 ug/mL

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
44567-602-24	Dexmedetomidine in Dextrose	24 in 1 CARTON	INJECTION	24		13
44567-602-24	Dexmedetomidine in Dextrose	50 mL in 1 BAG	INJECTION	50		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
44567-602-24	ML - Milliliter	44567-602	99081322-73b4-489e-b244-d2e8b6fecaa7	1	2018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
44567-602	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

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
44567-602-24	44567060224	24 BAG in 1 CARTON (44567-602-24) / 50 mL in 1 BAG (44567-602-01)	24 bag	2018-10-18	0000-00-00	No	No	Current