Precedex

Product NDC: 0409-1434
11-digit product format: 004091434
Labeler code: 0409
Product ID: 0409-1434_3c5274fd-6597-4b88-babc-92e4e16c6329
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DEXMEDETOMIDINE HYDROCHLORIDE
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Hospira, Inc.
Application: NDA021038
Marketing category: NDA
Marketing start: 2020-09-28
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 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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Precedex
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXMEDETOMIDINE HYDROCHLORIDE	4 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 · 10 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
284397	Internal RxNorm lookup
309710	Internal RxNorm lookup
1718900	Internal RxNorm lookup
1718902	Internal RxNorm lookup
1718906	Internal RxNorm lookup
1718907	Internal RxNorm lookup
1718909	Internal RxNorm lookup
1718910	Internal RxNorm lookup
2396891	Internal RxNorm lookup
2396892	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
548a88c0-afda-427e-75ac-5af0cfa2224c	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
0409-1434-01	Precedex	1 in 1 CARTON	INJECTION, SOLUTION	1		59
0409-1434-01	Precedex	250 mL in 1 BOTTLE	INJECTION, SOLUTION	250		59

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXMEDETOMIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	1018WH7F9I	PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]	27
DEXMEDETOMIDINE	ACTIVE MOIETY	67VB76HONO	PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]	27
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]	27
WATER	INACTIVE INGREDIENT	059QF0KO0R	PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]	27

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0409-1434	PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]	53	Current NDC, Legacy NDC, 2 package rows	20250326_548a88c0-afda-427e-75ac-5af0cfa2224c.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 · 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
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
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
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): 0409-1434

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
2396891	dexmedeTOMIDine 1000 MG in 250 mL Injection	PSN	548a88c0-afda-427e-75ac-5af0cfa2224c	59
309710	dexmedeTOMIDine HCl 200 MCG in 2 ML Injection	PSN	548a88c0-afda-427e-75ac-5af0cfa2224c	59
1718906	dexmedeTOMIDine HCl 200 MCG in 50 ML Injection	PSN	548a88c0-afda-427e-75ac-5af0cfa2224c	59
1718909	dexmedeTOMIDine HCl 400 MCG in 100 ML Injection	PSN	548a88c0-afda-427e-75ac-5af0cfa2224c	59
1718900	dexmedeTOMIDine HCl 80 MCG in 20 ML Injection	PSN	548a88c0-afda-427e-75ac-5af0cfa2224c	59
2396892	Precedex 1000 MCG in 250 mL Injection	PSN	548a88c0-afda-427e-75ac-5af0cfa2224c	59
284397	Precedex 200 MCG in 2 ML Injection	PSN	548a88c0-afda-427e-75ac-5af0cfa2224c	59
1718907	Precedex 200 MCG in 50 ML Injection	PSN	548a88c0-afda-427e-75ac-5af0cfa2224c	59
1718910	Precedex 400 MCG in 100 ML Injection	PSN	548a88c0-afda-427e-75ac-5af0cfa2224c	59
1718902	Precedex 80 MCG in 20 ML Injection	PSN	548a88c0-afda-427e-75ac-5af0cfa2224c	59
1718910	100 ML dexmedetomidine 0.004 MG/ML Injection [Precedex]	SBD	548a88c0-afda-427e-75ac-5af0cfa2224c	59
284397	2 ML dexmedetomidine 0.1 MG/ML Injection [Precedex]	SBD	548a88c0-afda-427e-75ac-5af0cfa2224c	59
1718902	20 ML dexmedetomidine 0.004 MG/ML Injection [Precedex]	SBD	548a88c0-afda-427e-75ac-5af0cfa2224c	59
2396892	250 ML dexmedetomidine 0.004 MG/ML Injection [Precedex]	SBD	548a88c0-afda-427e-75ac-5af0cfa2224c	59
1718907	50 ML dexmedetomidine 0.004 MG/ML Injection [Precedex]	SBD	548a88c0-afda-427e-75ac-5af0cfa2224c	59
1718909	100 ML dexmedetomidine 0.004 MG/ML Injection	SCD	548a88c0-afda-427e-75ac-5af0cfa2224c	59
309710	2 ML dexmedetomidine 0.1 MG/ML Injection	SCD	548a88c0-afda-427e-75ac-5af0cfa2224c	59
1718900	20 ML dexmedetomidine 0.004 MG/ML Injection	SCD	548a88c0-afda-427e-75ac-5af0cfa2224c	59
2396891	250 ML dexmedetomidine 0.004 MG/ML Injection	SCD	548a88c0-afda-427e-75ac-5af0cfa2224c	59
1718906	50 ML dexmedetomidine 0.004 MG/ML Injection	SCD	548a88c0-afda-427e-75ac-5af0cfa2224c	59
1718910	100 ML Precedex 0.004 MG/ML Injection	SY	548a88c0-afda-427e-75ac-5af0cfa2224c	59
284397	2 ML Precedex 0.1 MG/ML Injection	SY	548a88c0-afda-427e-75ac-5af0cfa2224c	59
1718902	20 ML Precedex 0.004 MG/ML Injection	SY	548a88c0-afda-427e-75ac-5af0cfa2224c	59
2396892	250 ML Precedex 0.004 MG/ML Injection	SY	548a88c0-afda-427e-75ac-5af0cfa2224c	59
1718907	50 ML Precedex 0.004 MG/ML Injection	SY	548a88c0-afda-427e-75ac-5af0cfa2224c	59
309710	dexmedetomidine (as dexmedetomidine HCl) 0.1 MG/ML per 2 ML Injection	SY	548a88c0-afda-427e-75ac-5af0cfa2224c	59
309710	dexmedetomidine (as dexmedetomidine HCl) 100 MCG/ML Injection	SY	548a88c0-afda-427e-75ac-5af0cfa2224c	59
1718906	dexmedetomidine (as dexmedetomidine HCl) 200 MCG per 50 ML Injection	SY	548a88c0-afda-427e-75ac-5af0cfa2224c	59
1718909	dexmedetomidine (as dexmedetomidine HCl) 400 MCG per 100 ML Injection	SY	548a88c0-afda-427e-75ac-5af0cfa2224c	59
1718900	dexmedetomidine (as dexmedetomidine HCl) 80 MCG per 20 ML Injection	SY	548a88c0-afda-427e-75ac-5af0cfa2224c	59
2396891	dexmedetomidine 0.004 MG/ML per 250 ML Injection	SY	548a88c0-afda-427e-75ac-5af0cfa2224c	59
2396891	dexmedetomidine 1000 MG per 250 ML Injection	SY	548a88c0-afda-427e-75ac-5af0cfa2224c	59
2396892	Precedex 1000 MCG per 250 ML Injection	SY	548a88c0-afda-427e-75ac-5af0cfa2224c	59
284397	Precedex 200 MCG per 2 ML Injection	SY	548a88c0-afda-427e-75ac-5af0cfa2224c	59
1718907	Precedex 200 MCG per 50 ML Injection	SY	548a88c0-afda-427e-75ac-5af0cfa2224c	59
1718910	Precedex 400 MCG per 100 ML Injection	SY	548a88c0-afda-427e-75ac-5af0cfa2224c	59
1718902	Precedex 80 MCG per 20 ML Injection	SY	548a88c0-afda-427e-75ac-5af0cfa2224c	59

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0409-1434-01	00409143401	1 BOTTLE in 1 CARTON (0409-1434-01) / 250 mL in 1 BOTTLE	1 bottle	2020-09-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Precedex	Hospira, Inc. \| Pfizer Healthcare India Private Limited	2026-05-20	HUMAN PRESCRIPTION DRUG LABEL	59