FDA.reportPublic FDA data

Precedex

Product NDC
0409-2815
11-digit product format
004092815
Labeler code
0409
Product ID
0409-2815_8d48de06-361f-418b-bfec-8ef85f94d5bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEXMEDETOMIDINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
NDA021038
Marketing category
NDA
Marketing start
2023-01-17
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
2026-12-31
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

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
0409-2815-01Precedex1 in 1 CARTONINJECTION, SOLUTION112
0409-2815-01Precedex250 mL in 1 BOTTLEINJECTION, SOLUTION25012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-2815-01ML - Milliliter0409-28155b63fc00-f4f8-40fc-b25f-b33359a6b6fe12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-2815PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]12Current NDC, 2 package rows20250202_4419162d-81d4-49bd-96de-1729440bdb74.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2396891dexmedeTOMIDine 1000 MG in 250 mL InjectionPSN4419162d-81d4-49bd-96de-1729440bdb7412
1718906dexmedeTOMIDine HCl 200 MCG in 50 ML InjectionPSN4419162d-81d4-49bd-96de-1729440bdb7412
1718909dexmedeTOMIDine HCl 400 MCG in 100 ML InjectionPSN4419162d-81d4-49bd-96de-1729440bdb7412
1718900dexmedeTOMIDine HCl 80 MCG in 20 ML InjectionPSN4419162d-81d4-49bd-96de-1729440bdb7412
2396892Precedex 1000 MCG in 250 mL InjectionPSN4419162d-81d4-49bd-96de-1729440bdb7412
1718907Precedex 200 MCG in 50 ML InjectionPSN4419162d-81d4-49bd-96de-1729440bdb7412
1718910Precedex 400 MCG in 100 ML InjectionPSN4419162d-81d4-49bd-96de-1729440bdb7412
1718902Precedex 80 MCG in 20 ML InjectionPSN4419162d-81d4-49bd-96de-1729440bdb7412
1718910100 ML dexmedetomidine 0.004 MG/ML Injection [Precedex]SBD4419162d-81d4-49bd-96de-1729440bdb7412
171890220 ML dexmedetomidine 0.004 MG/ML Injection [Precedex]SBD4419162d-81d4-49bd-96de-1729440bdb7412
2396892250 ML dexmedetomidine 0.004 MG/ML Injection [Precedex]SBD4419162d-81d4-49bd-96de-1729440bdb7412
171890750 ML dexmedetomidine 0.004 MG/ML Injection [Precedex]SBD4419162d-81d4-49bd-96de-1729440bdb7412
1718909100 ML dexmedetomidine 0.004 MG/ML InjectionSCD4419162d-81d4-49bd-96de-1729440bdb7412
171890020 ML dexmedetomidine 0.004 MG/ML InjectionSCD4419162d-81d4-49bd-96de-1729440bdb7412
2396891250 ML dexmedetomidine 0.004 MG/ML InjectionSCD4419162d-81d4-49bd-96de-1729440bdb7412
171890650 ML dexmedetomidine 0.004 MG/ML InjectionSCD4419162d-81d4-49bd-96de-1729440bdb7412
1718910100 ML Precedex 0.004 MG/ML InjectionSY4419162d-81d4-49bd-96de-1729440bdb7412
171890220 ML Precedex 0.004 MG/ML InjectionSY4419162d-81d4-49bd-96de-1729440bdb7412
2396892250 ML Precedex 0.004 MG/ML InjectionSY4419162d-81d4-49bd-96de-1729440bdb7412
171890750 ML Precedex 0.004 MG/ML InjectionSY4419162d-81d4-49bd-96de-1729440bdb7412
1718906dexmedetomidine (as dexmedetomidine HCl) 200 MCG per 50 ML InjectionSY4419162d-81d4-49bd-96de-1729440bdb7412
1718909dexmedetomidine (as dexmedetomidine HCl) 400 MCG per 100 ML InjectionSY4419162d-81d4-49bd-96de-1729440bdb7412
1718900dexmedetomidine (as dexmedetomidine HCl) 80 MCG per 20 ML InjectionSY4419162d-81d4-49bd-96de-1729440bdb7412
2396891dexmedetomidine 0.004 MG/ML per 250 ML InjectionSY4419162d-81d4-49bd-96de-1729440bdb7412
2396891dexmedetomidine 1000 MG per 250 ML InjectionSY4419162d-81d4-49bd-96de-1729440bdb7412
2396892Precedex 1000 MCG per 250 ML InjectionSY4419162d-81d4-49bd-96de-1729440bdb7412
1718907Precedex 200 MCG per 50 ML InjectionSY4419162d-81d4-49bd-96de-1729440bdb7412
1718910Precedex 400 MCG per 100 ML InjectionSY4419162d-81d4-49bd-96de-1729440bdb7412
1718902Precedex 80 MCG per 20 ML InjectionSY4419162d-81d4-49bd-96de-1729440bdb7412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0409-2815-01004092815011 BOTTLE in 1 CARTON (0409-2815-01) / 250 mL in 1 BOTTLE1 bottle2023-01-17NoNoHistorical