FDA.reportPublic FDA data

Dexmedetomidine

Product NDC
17478-055
11-digit product format
174780055
Labeler code
17478
Product ID
17478-055_70df3506-5cb1-4f18-9b0e-ebbdc4955b86
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexmedetomidine Hydrochloride
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Akorn
Application
ANDA202585
Marketing category
ANDA
Marketing start
2014-11-24
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17478-055-022024-01-30C16284748780-11030e365-5c50-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DEXMEDETOMIDINE HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE HYDROCHLORIDE INJECTION. DEXMEDETOMIDINE HYDROCHLORIDE Injection, for intravenous use Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17478-055-02Dexmedetomidine10 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE108
17478-055-02Dexmedetomidine2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17478-055-02ML - Milliliter17478-055149fbc8b-602d-415b-a9e8-20492f78efc512015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Dexmedetomidine HydrochlorideACTIVE INGREDIENT1018WH7F9IDEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [AKORN, INC. ]1
DexmedetomidineACTIVE MOIETY67VB76HONODEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [AKORN, INC. ]1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XDEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [AKORN, INC. ]1
WaterINACTIVE INGREDIENT059QF0KO0RDEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [AKORN, INC. ]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17478-055DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [AKORN]8Legacy NDC, 2 package rows20221027_8fb7886c-7762-4b72-989b-0fe8e963b4b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309710dexmedeTOMIDine HCl 200 MCG in 2 ML InjectionPSN8fb7886c-7762-4b72-989b-0fe8e963b4b88
3097102 ML dexmedetomidine 0.1 MG/ML InjectionSCD8fb7886c-7762-4b72-989b-0fe8e963b4b88
309710dexmedetomidine (as dexmedetomidine HCl) 0.1 MG/ML per 2 ML InjectionSY8fb7886c-7762-4b72-989b-0fe8e963b4b88
309710dexmedetomidine (as dexmedetomidine HCl) 100 MCG/ML InjectionSY8fb7886c-7762-4b72-989b-0fe8e963b4b88

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
17478-055-021747800550210 VIAL, SINGLE-DOSE in 1 CARTON (17478-055-02) > 2 mL in 1 VIAL, SINGLE-DOSE2014-11-240000-00-00NoNoCurrent