FDA.reportPublic FDA data

Precedex

Product NDC
0409-4596
11-digit product format
004094596
Labeler code
0409
Product ID
0409-4596_58e27ec5-ccde-46c9-afd3-2509e6b55e4e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEXMEDETOMIDINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
NDA021038
Marketing category
NDA
Marketing start
2023-01-03
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
Rxcui1718906, 1718907, 1718909, 1718910

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
0409-4596-01Precedex50 mL in 1 BOTTLEINJECTION, SOLUTION505
0409-4596-20Precedex20 in 1 TRAYINJECTION, SOLUTION205

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-4596-01ML - Milliliter0409-4596c2d3fdc9-ebc3-4c43-a42c-ee59edbcbeb612023-02-06
0409-4596-20ML - Milliliter0409-4596a9123f55-0132-494f-bbcc-c48e590681d212023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-4596PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]4Current NDC, Legacy NDC, 2 package rows20250316_92b7ddaa-e45a-4b64-a802-bb5df8771dd6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1718906dexmedeTOMIDine HCl 200 MCG in 50 ML InjectionPSN92b7ddaa-e45a-4b64-a802-bb5df8771dd65
1718909dexmedeTOMIDine HCl 400 MCG in 100 ML InjectionPSN92b7ddaa-e45a-4b64-a802-bb5df8771dd65
1718907Precedex 200 MCG in 50 ML InjectionPSN92b7ddaa-e45a-4b64-a802-bb5df8771dd65
1718910Precedex 400 MCG in 100 ML InjectionPSN92b7ddaa-e45a-4b64-a802-bb5df8771dd65
1718910100 ML dexmedetomidine 0.004 MG/ML Injection [Precedex]SBD92b7ddaa-e45a-4b64-a802-bb5df8771dd65
171890750 ML dexmedetomidine 0.004 MG/ML Injection [Precedex]SBD92b7ddaa-e45a-4b64-a802-bb5df8771dd65
1718909100 ML dexmedetomidine 0.004 MG/ML InjectionSCD92b7ddaa-e45a-4b64-a802-bb5df8771dd65
171890650 ML dexmedetomidine 0.004 MG/ML InjectionSCD92b7ddaa-e45a-4b64-a802-bb5df8771dd65
1718910100 ML Precedex 0.004 MG/ML InjectionSY92b7ddaa-e45a-4b64-a802-bb5df8771dd65
171890750 ML Precedex 0.004 MG/ML InjectionSY92b7ddaa-e45a-4b64-a802-bb5df8771dd65
1718906dexmedetomidine (as dexmedetomidine HCl) 200 MCG per 50 ML InjectionSY92b7ddaa-e45a-4b64-a802-bb5df8771dd65
1718909dexmedetomidine (as dexmedetomidine HCl) 400 MCG per 100 ML InjectionSY92b7ddaa-e45a-4b64-a802-bb5df8771dd65
1718907Precedex 200 MCG per 50 ML InjectionSY92b7ddaa-e45a-4b64-a802-bb5df8771dd65
1718910Precedex 400 MCG per 100 ML InjectionSY92b7ddaa-e45a-4b64-a802-bb5df8771dd65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-4596-010040945960150 mL in 1 BOTTLE50 mlHistorical
0409-4596-200040945962020 BOTTLE in 1 TRAY (0409-4596-20) / 50 mL in 1 BOTTLE (0409-4596-01) 20 bottle2023-01-030000-00-00NoNoCurrent