Application 206628

Type: NDA
Sponsor: HQ SPCLT PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	SOLUTION;INTRAVENOUS	EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)	Yes	No
002	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	SOLUTION;INTRAVENOUS	EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)	Yes	Yes
003	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	SOLUTION;INTRAVENOUS	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	Yes	No
004	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	SOLUTION;INTRAVENOUS	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	Yes	No

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…`

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 2 of 2 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexmedetomidine Hydrochloride	DEXMEDETOMIDINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	a268e759-9a3e-1d7b-e053-2a95a90a335b	2023-06-01	Warnings, Adverse reactions	Name fallback brand name: Dexmedetomidine Hydrochloride generic name: DEXMEDETOMIDINE HYDROCHLORIDE
Dexmedetomidine hydrochloride	DEXMEDETOMIDINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	a2666c50-3b55-1380-e053-2a95a90aea58	2023-06-01	Warnings, Adverse reactions	Name fallback brand name: Dexmedetomidine hydrochloride generic name: DEXMEDETOMIDINE HYDROCHLORIDE
Dexmedetomidine Hydrochloride	DEXMEDETOMIDINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	6937235f-ea25-4950-e053-2991aa0a9b74	2023-05-23	Warnings, Adverse reactions	Name fallback brand name: Dexmedetomidine Hydrochloride generic name: DEXMEDETOMIDINE HYDROCHLORIDE
DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	Dr.Reddy's Laboratories Inc	d174c19d-56f1-4ef4-087c-23c26db8e40b	2022-07-01	Warnings, Adverse reactions	Name fallback brand name: DEXMEDETOMIDINE HYDROCHLORIDE generic name: DEXMEDETOMIDINE HYDROCHLORIDE
Dexmedetomidine Hydrochloride	DEXMEDETOMIDINE HYDROCHLORIDE	Sun Pharmaceuticals Industries, Inc.	4fe788bc-4ad1-4b32-83d3-dcbfcd8429aa	2018-08-20	Warnings, Adverse reactions	Name fallback brand name: Dexmedetomidine Hydrochloride generic name: DEXMEDETOMIDINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
44567-600	Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride	WG Critical Care, LLC	NDA	Current
44567-600	Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride	WG Critical Care, LLC	NDA	Current
44567-600	Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride	WG Critical Care, LLC	NDA	Current
44567-601	Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride	WG Critical Care, LLC	NDA	Current
44567-601	Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride	WG Critical Care, LLC	NDA	Current
44567-601	Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride	WG Critical Care, LLC	NDA	Current
44567-602	Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride	WG Critical Care, LLC	NDA	Current
44567-602	Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride	WG Critical Care, LLC	NDA	Current
44567-602	Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride	WG Critical Care, LLC	NDA	Current
44567-603	Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride	WG Critical Care, LLC	NDA	Current
44567-603	Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride	WG Critical Care, LLC	NDA	Current
44567-603	Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride	WG Critical Care, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85835	SUPPL	2026-05-05
85823	SUPPL	2026-05-04
77928	SUPPL	2024-03-25
77915	SUPPL	2024-03-22
75286	SUPPL	2023-08-25
75269	SUPPL	2023-08-23
45380	SUPPL	2016-09-21
45352	SUPPL	2016-09-21
43526	ORIG	2016-05-27
19729	ORIG	2015-10-26
10589	ORIG	2015-10-23