Application 021038

Type: NDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PRECEDEX	DEXMEDETOMIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	Yes	Yes
002	PRECEDEX	DEXMEDETOMIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	Yes	Yes
003	PRECEDEX	DEXMEDETOMIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	Yes	Yes
004	PRECEDEX	DEXMEDETOMIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	Yes	Yes
005	PRECEDEX	DEXMEDETOMIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 1MG BASE/250ML (EQ 4MCG BASE/ML)	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021038-001	PRECEDEX	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1999-12-17
N021038-002	PRECEDEX	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2013-03-13
N021038-003	PRECEDEX	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2013-03-13
N021038-004	PRECEDEX	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2014-11-14
N021038-005	PRECEDEX	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 1MG BASE/250ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2020-01-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
N021038-001	AP
N021038-002	AP
N021038-003	AP
N021038-004	AP
N021038-005	AP

Orange Book patents#

Current patent rows page 1 of 1 · 38 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N021038-002	10016396	2032-01-04		Drug product	2018-08-09
N021038-002	8242158	2032-01-04		Drug product	2013-05-21
N021038-002	8338470	2032-01-04		Drug product	2013-05-21
N021038-002	8455527	2032-01-04	U-421
N021038-002	8648106	2032-01-04		Drug product	2014-03-05
N021038-002	9320712	2032-01-04		Drug product	2016-09-19
N021038-002	9616049	2032-01-04		Drug product	2017-05-09
N021038-002	8242158*PED	2032-07-04		Pediatric extension
N021038-002	8338470*PED	2032-07-04		Pediatric extension
N021038-002	8455527*PED	2032-07-04		Pediatric extension
N021038-002	8648106*PED	2032-07-04		Pediatric extension
N021038-002	9320712*PED	2032-07-04		Pediatric extension
N021038-002	9616049*PED	2032-07-04		Pediatric extension
N021038-003	10016396	2032-01-04		Drug product	2018-08-09
N021038-003	8242158	2032-01-04		Drug product
N021038-003	8338470	2032-01-04		Drug product
N021038-003	8455527	2032-01-04	U-421
N021038-003	8648106	2032-01-04		Drug product	2014-03-05
N021038-003	9320712	2032-01-04		Drug product	2016-09-19
N021038-003	9616049	2032-01-04		Drug product	2017-05-09
N021038-003	8242158*PED	2032-07-04		Pediatric extension
N021038-003	8338470*PED	2032-07-04		Pediatric extension
N021038-003	8455527*PED	2032-07-04		Pediatric extension
N021038-003	8648106*PED	2032-07-04		Pediatric extension
N021038-003	9320712*PED	2032-07-04		Pediatric extension
N021038-003	9616049*PED	2032-07-04		Pediatric extension
N021038-004	8242158	2032-01-04		Drug product	2015-01-30
N021038-004	8338470	2032-01-04		Drug product	2015-01-30
N021038-004	8455527	2032-01-04	U-421		2015-01-30
N021038-004	8648106	2032-01-04		Drug product	2015-01-30
N021038-004	9320712	2032-01-04		Drug product	2016-09-19
N021038-004	9616049	2032-01-04		Drug product	2017-05-09
N021038-004	8242158*PED	2032-07-04		Pediatric extension
N021038-004	8338470*PED	2032-07-04		Pediatric extension
N021038-004	8455527*PED	2032-07-04		Pediatric extension
N021038-004	8648106*PED	2032-07-04		Pediatric extension
N021038-004	9320712*PED	2032-07-04		Pediatric extension
N021038-004	9616049*PED	2032-07-04		Pediatric extension

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 6 · 206 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
2026-08-18 06:07:40	2026-07	N021038-001	PRECEDEX	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1999-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021038-002	PRECEDEX	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2013-03-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021038-003	PRECEDEX	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2013-03-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021038-004	PRECEDEX	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2014-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021038-005	PRECEDEX	EQ 1MG BASE/250ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2020-01-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021038-001	PRECEDEX	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1999-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021038-002	PRECEDEX	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2013-03-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021038-003	PRECEDEX	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2013-03-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021038-004	PRECEDEX	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2014-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021038-005	PRECEDEX	EQ 1MG BASE/250ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2020-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021038-001	PRECEDEX	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1999-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021038-002	PRECEDEX	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2013-03-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021038-003	PRECEDEX	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2013-03-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021038-004	PRECEDEX	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2014-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021038-005	PRECEDEX	EQ 1MG BASE/250ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2020-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021038-001	PRECEDEX	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1999-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021038-002	PRECEDEX	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2013-03-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021038-003	PRECEDEX	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2013-03-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021038-004	PRECEDEX	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2014-11-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021038-005	PRECEDEX	EQ 1MG BASE/250ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2020-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021038-001	PRECEDEX	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1999-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021038-002	PRECEDEX	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2013-03-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021038-003	PRECEDEX	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2013-03-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021038-004	PRECEDEX	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2014-11-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021038-005	PRECEDEX	EQ 1MG BASE/250ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2020-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021038-001	PRECEDEX	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1999-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021038-002	PRECEDEX	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2013-03-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021038-003	PRECEDEX	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2013-03-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021038-004	PRECEDEX	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2014-11-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021038-005	PRECEDEX	EQ 1MG BASE/250ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2020-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021038-001	PRECEDEX	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1999-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021038-002	PRECEDEX	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2013-03-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021038-003	PRECEDEX	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2013-03-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021038-004	PRECEDEX	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2014-11-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021038-005	PRECEDEX	EQ 1MG BASE/250ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2020-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021038-001	PRECEDEX	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1999-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021038-002	PRECEDEX	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2013-03-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021038-003	PRECEDEX	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2013-03-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021038-004	PRECEDEX	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2014-11-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021038-005	PRECEDEX	EQ 1MG BASE/250ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2020-01-31	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 173 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	N021038-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021038-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021038-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021038-004	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021038-005	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021038-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021038-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021038-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021038-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021038-005	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021038-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021038-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021038-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021038-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021038-005	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021038-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021038-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021038-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021038-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021038-005	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021038-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021038-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021038-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021038-004	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021038-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021038-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021038-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021038-004	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021038-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021038-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021038-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021038-004	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021038-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021038-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021038-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021038-004	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021038-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021038-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021038-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021038-004	AP	1	`5bbf6a4d5a75…`

Observed Orange Book patent history#

Patent history page 1 of 41 · 1,628 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021038-002	10016396	2032-01-04		Drug product	2018-08-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021038-002	8242158	2032-01-04		Drug product	2013-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021038-002	8338470	2032-01-04		Drug product	2013-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021038-002	8455527	2032-01-04	U-421			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021038-002	8648106	2032-01-04		Drug product	2014-03-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021038-002	9320712	2032-01-04		Drug product	2016-09-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021038-002	9616049	2032-01-04		Drug product	2017-05-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021038-002	8242158*PED	2032-07-04		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021038-002	8338470*PED	2032-07-04		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021038-002	8455527*PED	2032-07-04		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021038-002	8648106*PED	2032-07-04		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021038-002	9320712*PED	2032-07-04		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021038-002	9616049*PED	2032-07-04		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021038-003	10016396	2032-01-04		Drug product	2018-08-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021038-003	8242158	2032-01-04		Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021038-003	8338470	2032-01-04		Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021038-003	8455527	2032-01-04	U-421			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021038-003	8648106	2032-01-04		Drug product	2014-03-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021038-003	9320712	2032-01-04		Drug product	2016-09-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021038-003	9616049	2032-01-04		Drug product	2017-05-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021038-003	8242158*PED	2032-07-04		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021038-003	8338470*PED	2032-07-04		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021038-003	8455527*PED	2032-07-04		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021038-003	8648106*PED	2032-07-04		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021038-003	9320712*PED	2032-07-04		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021038-003	9616049*PED	2032-07-04		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021038-004	8242158	2032-01-04		Drug product	2015-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021038-004	8338470	2032-01-04		Drug product	2015-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021038-004	8455527	2032-01-04	U-421		2015-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021038-004	8648106	2032-01-04		Drug product	2015-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021038-004	9320712	2032-01-04		Drug product	2016-09-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021038-004	9616049	2032-01-04		Drug product	2017-05-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021038-004	8242158*PED	2032-07-04		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021038-004	8338470*PED	2032-07-04		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021038-004	8455527*PED	2032-07-04		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021038-004	8648106*PED	2032-07-04		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021038-004	9320712*PED	2032-07-04		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021038-004	9616049*PED	2032-07-04		Pediatric extension		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021038-002	10016396	2032-01-04		Drug product	2018-08-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021038-002	8242158	2032-01-04		Drug product	2013-05-21	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 105 observed states.

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	N021038-001	NPP	2025-12-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021038-002	NPP	2025-12-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021038-003	NPP	2025-12-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021038-004	NPP	2025-12-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021038-005	NPP	2025-12-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021038-001	NPP	2025-12-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021038-002	NPP	2025-12-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021038-003	NPP	2025-12-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021038-004	NPP	2025-12-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021038-005	NPP	2025-12-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021038-001	NPP	2025-12-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021038-002	NPP	2025-12-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021038-003	NPP	2025-12-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021038-004	NPP	2025-12-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021038-005	NPP	2025-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021038-001	NPP	2025-12-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021038-002	NPP	2025-12-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021038-003	NPP	2025-12-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021038-004	NPP	2025-12-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021038-005	NPP	2025-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021038-001	NPP	2025-12-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021038-002	NPP	2025-12-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021038-003	NPP	2025-12-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021038-004	NPP	2025-12-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021038-005	NPP	2025-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021038-001	NPP	2025-12-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021038-002	NPP	2025-12-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021038-003	NPP	2025-12-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021038-004	NPP	2025-12-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021038-005	NPP	2025-12-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021038-001	NPP	2025-12-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021038-002	NPP	2025-12-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021038-003	NPP	2025-12-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021038-004	NPP	2025-12-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021038-005	NPP	2025-12-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021038-001	NPP	2025-12-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021038-002	NPP	2025-12-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021038-003	NPP	2025-12-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021038-004	NPP	2025-12-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021038-005	NPP	2025-12-16	`d8e5a09893c0…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	92b7ddaa-e45a-4b64-a802-bb5df8771dd6	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021038 application number: NDA021038 ndc (product): 0409-0155 ndc (product): 0409-4596
Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	4419162d-81d4-49bd-96de-1729440bdb74	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021038 application number: NDA021038 ndc (product): 0409-3301 ndc (product): 0409-1174 ndc (product): 0409-1454
PRECEDEX	DEXMEDETOMIDINE HYDROCHLORIDE	Henry Schein, Inc.	9eb336de-5fa5-4b46-b40b-a7ca5a0864bd	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021038 application number: NDA021038 ndc (product): 0404-9938
Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	548a88c0-afda-427e-75ac-5af0cfa2224c	2026-05-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021038 application number: NDA021038 ndc (product): 0409-1660 ndc (product): 0409-1638 ndc (product): 0409-1434

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 48 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9938	PRECEDEX	DEXMEDETOMIDINE HYDROCHLORIDE	Henry Schein, Inc.	NDA	Current
0404-9938	PRECEDEX	DEXMEDETOMIDINE HYDROCHLORIDE	Henry Schein, Inc.	NDA	Current
0404-9938	PRECEDEX	DEXMEDETOMIDINE HYDROCHLORIDE	Henry Schein, Inc.	NDA	Current
0409-0155	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1174	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1174	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1174	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1174	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1174	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1434	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1434	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1434	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1434	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1434	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1434	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1434	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1454	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1454	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1638	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1638	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1638	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1638	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1638	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1638	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1638	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1638	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1638	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1638	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1660	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1660	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1660	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1660	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1660	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1660	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1660	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1660	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1660	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1660	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-3301	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-3301	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-3301	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-3301	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-3301	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-4596	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
52584-638	PRECEDEX	DEXMEDETOMIDINE HYDROCHLORIDE	General Injectables and Vaccines, Inc.	NDA	Current
52584-638	PRECEDEX	DEXMEDETOMIDINE HYDROCHLORIDE	General Injectables and Vaccines, Inc.	NDA	Current
52584-638	PRECEDEX	DEXMEDETOMIDINE HYDROCHLORIDE	General Injectables and Vaccines, Inc.	NDA	Current
52584-638	PRECEDEX	DEXMEDETOMIDINE HYDROCHLORIDE	General Injectables and Vaccines, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85834	SUPPL	2026-05-05
85822	SUPPL	2026-05-04
79959	SUPPL	2024-10-22
79958	SUPPL	2024-10-22
72933	SUPPL	2022-12-20
72925	SUPPL	2022-12-19
71804	SUPPL	2022-08-15
71803	SUPPL	2022-08-15
71796	SUPPL	2022-08-15
71795	SUPPL	2022-08-15
62048	SUPPL	2020-03-05
62041	SUPPL	2020-03-05
35958	SUPPL	2016-04-12
4133	SUPPL	2016-04-12
21368	SUPPL	2015-07-21
26562	SUPPL	2014-12-01
4132	SUPPL	2014-12-01
4130	SUPPL	2014-12-01
35957	SUPPL	2014-11-20
35954	SUPPL	2014-11-20
14226	SUPPL	2014-11-20
21367	SUPPL	2013-10-21
26561	SUPPL	2013-06-18
4131	SUPPL	2013-06-18
35956	SUPPL	2013-06-17
14225	SUPPL	2013-06-17
35955	SUPPL	2013-03-19
64787	ORIG	2011-08-31
51513	SUPPL	2011-08-30
51512	SUPPL	2011-08-30
51511	SUPPL	2010-12-14
51510	SUPPL	2010-12-14
14224	SUPPL	2010-10-19
4129	SUPPL	2010-10-19
26560	SUPPL	2008-10-21
51509	SUPPL	2007-03-14
51508	SUPPL	2007-03-14
21366	ORIG	1999-12-17
14223	ORIG	1999-12-17
4128	ORIG	1999-12-17
63900	ORIG	1900-01-01
63899	ORIG	1900-01-01
58105	ORIG	1900-01-01
52610	SUPPL	1900-01-01
52609	SUPPL	1900-01-01
52608	SUPPL	1900-01-01