Precedex

Product NDC: 0409-1638
11-digit product format: 004091638
Labeler code: 0409
Product ID: 0409-1638_3c5274fd-6597-4b88-babc-92e4e16c6329
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DEXMEDETOMIDINE HYDROCHLORIDE
Dosage form: INJECTION, SOLUTION, CONCENTRATE
Route: INTRAVENOUS
Labeler: Hospira, Inc.
Application: NDA021038
Marketing category: NDA
Marketing start: 2004-11-30
Substance: DEXMEDETOMIDINE HYDROCHLORIDE
Active strength: 100 ug/mL
Pharmacologic classes: Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXMEDETOMIDINE HYDROCHLORIDE	100 ug/mL

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	1018WH7F9I
Rxcui	284397, 309710, 1718900, 1718902, 1718906, 1718907, 1718909, 1718910, 2396891, 2396892

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
0409-1638-02	Precedex	25 in 1 TRAY	INJECTION, SOLUTION, CONCENTRATE	25		59
0409-1638-32	Precedex	2 mL in 1 VIAL	INJECTION, SOLUTION, CONCENTRATE	2		59

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0409-1638-02	ML - Milliliter	0409-1638	916f421e-ac89-41f2-b358-cf65a43a74ab	1	2012-07-24
0409-1638-32	ML - Milliliter	0409-1638	92fff220-deb7-4e70-a294-f076f1f5df1f	1	2020-02-13

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
0409-1638	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

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
309710	dexmedeTOMIDine HCl 200 MCG in 2 ML Injection	PSN	9eb336de-5fa5-4b46-b40b-a7ca5a0864bd	9
284397	Precedex 200 MCG in 2 ML Injection	PSN	9eb336de-5fa5-4b46-b40b-a7ca5a0864bd	9
284397	2 ML dexmedetomidine 0.1 MG/ML Injection [Precedex]	SBD	9eb336de-5fa5-4b46-b40b-a7ca5a0864bd	9
309710	2 ML dexmedetomidine 0.1 MG/ML Injection	SCD	9eb336de-5fa5-4b46-b40b-a7ca5a0864bd	9
284397	2 ML Precedex 0.1 MG/ML Injection	SY	9eb336de-5fa5-4b46-b40b-a7ca5a0864bd	9
309710	dexmedetomidine (as dexmedetomidine HCl) 0.1 MG/ML per 2 ML Injection	SY	9eb336de-5fa5-4b46-b40b-a7ca5a0864bd	9
309710	dexmedetomidine (as dexmedetomidine HCl) 100 MCG/ML Injection	SY	9eb336de-5fa5-4b46-b40b-a7ca5a0864bd	9
284397	Precedex 200 MCG per 2 ML Injection	SY	9eb336de-5fa5-4b46-b40b-a7ca5a0864bd	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0409-1638-02	00409163802	25 VIAL in 1 TRAY (0409-1638-02) / 2 mL in 1 VIAL (0409-1638-32)	25 vial	2004-11-30	0000-00-00	No	No	Current
0409-1638-32	00409163832	2 mL in 1 VIAL	2 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PRECEDEX	Henry Schein, Inc.	2026-05-21	HUMAN PRESCRIPTION DRUG LABEL	9
Precedex	Hospira, Inc. \| Pfizer Healthcare India Private Limited	2026-05-20	HUMAN PRESCRIPTION DRUG LABEL	59

Precedex

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#