FDA.reportPublic FDA data

Precedex

Product NDC
0409-7853
11-digit product format
004097853
Labeler code
0409
Product ID
0409-7853_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
2025-03-24
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXMEDETOMIDINE HYDROCHLORIDE4 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1018WH7F9I
Rxcui284397, 309710, 1718900, 1718902, 1718906, 1718907, 1718909, 1718910, 2396891, 2396892

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ec136f1-cd53-4b90-826e-3eaeec54dca0Product name220250401
acae4bed-c293-9f7e-61b9-d68b8475ed3aProduct name220230104
536fa340-f745-6c4e-1ad7-a3c414722bccProduct name920170706

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-7853-01Precedex100 mL in 1 BAGINJECTION, SOLUTION10059
0409-7853-24Precedex1 in 1 POUCHINJECTION, SOLUTION159
0409-7853-24Precedex24 in 1 CASEINJECTION, SOLUTION2459

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-7853-01ML - Milliliter0409-785322f66a01-02c4-4682-be1e-7e488849c6af12025-05-14
0409-7853-24ML - Milliliter0409-785341659e11-d143-433e-b66e-361cee6e998812025-05-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXMEDETOMIDINE HYDROCHLORIDEACTIVE INGREDIENT1018WH7F9IPRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]27
DEXMEDETOMIDINEACTIVE MOIETY67VB76HONOPRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]27
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XPRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]27
WATERINACTIVE INGREDIENT059QF0KO0RPRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]27

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-7853PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]53Current NDC, 3 package rows20250326_548a88c0-afda-427e-75ac-5af0cfa2224c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2396891dexmedeTOMIDine 1000 MG in 250 mL InjectionPSN548a88c0-afda-427e-75ac-5af0cfa2224c59
309710dexmedeTOMIDine HCl 200 MCG in 2 ML InjectionPSN548a88c0-afda-427e-75ac-5af0cfa2224c59
1718906dexmedeTOMIDine HCl 200 MCG in 50 ML InjectionPSN548a88c0-afda-427e-75ac-5af0cfa2224c59
1718909dexmedeTOMIDine HCl 400 MCG in 100 ML InjectionPSN548a88c0-afda-427e-75ac-5af0cfa2224c59
1718900dexmedeTOMIDine HCl 80 MCG in 20 ML InjectionPSN548a88c0-afda-427e-75ac-5af0cfa2224c59
2396892Precedex 1000 MCG in 250 mL InjectionPSN548a88c0-afda-427e-75ac-5af0cfa2224c59
284397Precedex 200 MCG in 2 ML InjectionPSN548a88c0-afda-427e-75ac-5af0cfa2224c59
1718907Precedex 200 MCG in 50 ML InjectionPSN548a88c0-afda-427e-75ac-5af0cfa2224c59
1718910Precedex 400 MCG in 100 ML InjectionPSN548a88c0-afda-427e-75ac-5af0cfa2224c59
1718902Precedex 80 MCG in 20 ML InjectionPSN548a88c0-afda-427e-75ac-5af0cfa2224c59
1718910100 ML dexmedetomidine 0.004 MG/ML Injection [Precedex]SBD548a88c0-afda-427e-75ac-5af0cfa2224c59
2843972 ML dexmedetomidine 0.1 MG/ML Injection [Precedex]SBD548a88c0-afda-427e-75ac-5af0cfa2224c59
171890220 ML dexmedetomidine 0.004 MG/ML Injection [Precedex]SBD548a88c0-afda-427e-75ac-5af0cfa2224c59
2396892250 ML dexmedetomidine 0.004 MG/ML Injection [Precedex]SBD548a88c0-afda-427e-75ac-5af0cfa2224c59
171890750 ML dexmedetomidine 0.004 MG/ML Injection [Precedex]SBD548a88c0-afda-427e-75ac-5af0cfa2224c59
1718909100 ML dexmedetomidine 0.004 MG/ML InjectionSCD548a88c0-afda-427e-75ac-5af0cfa2224c59
3097102 ML dexmedetomidine 0.1 MG/ML InjectionSCD548a88c0-afda-427e-75ac-5af0cfa2224c59
171890020 ML dexmedetomidine 0.004 MG/ML InjectionSCD548a88c0-afda-427e-75ac-5af0cfa2224c59
2396891250 ML dexmedetomidine 0.004 MG/ML InjectionSCD548a88c0-afda-427e-75ac-5af0cfa2224c59
171890650 ML dexmedetomidine 0.004 MG/ML InjectionSCD548a88c0-afda-427e-75ac-5af0cfa2224c59
1718910100 ML Precedex 0.004 MG/ML InjectionSY548a88c0-afda-427e-75ac-5af0cfa2224c59
2843972 ML Precedex 0.1 MG/ML InjectionSY548a88c0-afda-427e-75ac-5af0cfa2224c59
171890220 ML Precedex 0.004 MG/ML InjectionSY548a88c0-afda-427e-75ac-5af0cfa2224c59
2396892250 ML Precedex 0.004 MG/ML InjectionSY548a88c0-afda-427e-75ac-5af0cfa2224c59
171890750 ML Precedex 0.004 MG/ML InjectionSY548a88c0-afda-427e-75ac-5af0cfa2224c59
309710dexmedetomidine (as dexmedetomidine HCl) 0.1 MG/ML per 2 ML InjectionSY548a88c0-afda-427e-75ac-5af0cfa2224c59
309710dexmedetomidine (as dexmedetomidine HCl) 100 MCG/ML InjectionSY548a88c0-afda-427e-75ac-5af0cfa2224c59
1718906dexmedetomidine (as dexmedetomidine HCl) 200 MCG per 50 ML InjectionSY548a88c0-afda-427e-75ac-5af0cfa2224c59
1718909dexmedetomidine (as dexmedetomidine HCl) 400 MCG per 100 ML InjectionSY548a88c0-afda-427e-75ac-5af0cfa2224c59
1718900dexmedetomidine (as dexmedetomidine HCl) 80 MCG per 20 ML InjectionSY548a88c0-afda-427e-75ac-5af0cfa2224c59
2396891dexmedetomidine 0.004 MG/ML per 250 ML InjectionSY548a88c0-afda-427e-75ac-5af0cfa2224c59
2396891dexmedetomidine 1000 MG per 250 ML InjectionSY548a88c0-afda-427e-75ac-5af0cfa2224c59
2396892Precedex 1000 MCG per 250 ML InjectionSY548a88c0-afda-427e-75ac-5af0cfa2224c59
284397Precedex 200 MCG per 2 ML InjectionSY548a88c0-afda-427e-75ac-5af0cfa2224c59
1718907Precedex 200 MCG per 50 ML InjectionSY548a88c0-afda-427e-75ac-5af0cfa2224c59
1718910Precedex 400 MCG per 100 ML InjectionSY548a88c0-afda-427e-75ac-5af0cfa2224c59
1718902Precedex 80 MCG per 20 ML InjectionSY548a88c0-afda-427e-75ac-5af0cfa2224c59

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0409-7853-0100409785301100 mL in 1 BAG100 mlHistorical
0409-7853-240040978532424 POUCH in 1 CASE (0409-7853-24) / 1 BAG in 1 POUCH / 100 mL in 1 BAG (0409-7853-01) 24 pouch2025-03-24NoNoCurrent