FDA.reportPublic FDA data

Precedex

Product NDC
0409-1660
11-digit product format
004091660
Labeler code
0409
Product ID
0409-1660_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
2013-04-08
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
0409-1660-10Precedex10 in 1 TRAYINJECTION, SOLUTION1059
0409-1660-20Precedex10 in 1 CARTONINJECTION, SOLUTION1059
0409-1660-22Precedex20 mL in 1 VIALINJECTION, SOLUTION2059
0409-1660-35Precedex100 mL in 1 BOTTLEINJECTION, SOLUTION10059
0409-1660-50Precedex20 in 1 TRAYINJECTION, SOLUTION2059
0409-1660-55Precedex50 mL in 1 BOTTLEINJECTION, SOLUTION5059

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-1660-10ML - Milliliter0409-16607725a4fb-45da-4c68-bca1-4aaee9320b4612013-05-02
0409-1660-20ML - Milliliter0409-1660910b75e2-bf83-49b4-bab6-0b4460bb129212015-03-03
0409-1660-22ML - Milliliter0409-166087b29a72-d5d1-414e-badf-d84f3952365c12020-02-13
0409-1660-35ML - Milliliter0409-1660f50eb05a-11d7-4bc6-8618-8e9a30ffbcc012020-02-13
0409-1660-50ML - Milliliter0409-1660c04c27d3-e418-4b0b-8aff-e5222f358eb712013-05-02
0409-1660-55ML - Milliliter0409-16600790a7d4-6cb6-4f81-8bcf-f69de763208812020-02-13

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
0409-1660PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]53Current NDC, Legacy NDC, 6 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 startMarketing endSampleExclude flagStatus
0409-1660-100040916601010 BOTTLE in 1 TRAY (0409-1660-10) / 100 mL in 1 BOTTLE (0409-1660-35) 10 bottle2013-04-080000-00-00NoNoCurrent
0409-1660-200040916602010 VIAL in 1 CARTON (0409-1660-20) / 20 mL in 1 VIAL (0409-1660-22) 10 vial2015-01-050000-00-00NoNoCurrent
0409-1660-220040916602220 mL in 1 VIAL20 mlHistorical
0409-1660-3500409166035100 mL in 1 BOTTLE100 mlHistorical
0409-1660-500040916605020 BOTTLE in 1 TRAY (0409-1660-50) / 50 mL in 1 BOTTLE (0409-1660-55) 20 bottle2013-04-080000-00-00NoNoCurrent
0409-1660-550040916605550 mL in 1 BOTTLE50 mlHistorical