FDA.reportPublic FDA data

DEXMEDETOMIDINE HYDROCHLORIDE

Product NDC
67457-925
11-digit product format
674570925
Labeler code
67457
Product ID
67457-925_b51a1fb0-fcee-4a76-9eaf-91c35813c242
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEXMEDETOMIDINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
ANDA212571
Marketing category
ANDA
Marketing start
2020-11-13
Substance
DEXMEDETOMIDINE HYDROCHLORIDE
Active strength
400 ug/100mL
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
DEXMEDETOMIDINE HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXMEDETOMIDINE HYDROCHLORIDE400 ug/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1018WH7F9I
Rxcui1718906, 1718909

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
67457-925-00DEXMEDETOMIDINE HYDROCHLORIDE100 mL in 1 BOTTLEINJECTION, SOLUTION1004
67457-925-10DEXMEDETOMIDINE HYDROCHLORIDE10 in 1 CARTONINJECTION, SOLUTION104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-925DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]3Current NDC, Legacy NDC, 2 package rows20250410_f140de5a-f13d-46b4-a742-049c63e474f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1718906dexmedeTOMIDine HCl 200 MCG in 50 ML InjectionPSNf140de5a-f13d-46b4-a742-049c63e474f54
1718909dexmedeTOMIDine HCl 400 MCG in 100 ML InjectionPSNf140de5a-f13d-46b4-a742-049c63e474f54
1718909100 ML dexmedetomidine 0.004 MG/ML InjectionSCDf140de5a-f13d-46b4-a742-049c63e474f54
171890650 ML dexmedetomidine 0.004 MG/ML InjectionSCDf140de5a-f13d-46b4-a742-049c63e474f54
1718906dexmedetomidine (as dexmedetomidine HCl) 200 MCG per 50 ML InjectionSYf140de5a-f13d-46b4-a742-049c63e474f54
1718909dexmedetomidine (as dexmedetomidine HCl) 400 MCG per 100 ML InjectionSYf140de5a-f13d-46b4-a742-049c63e474f54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67457-925-0067457092500100 mL in 1 BOTTLE100 mlHistorical
67457-925-106745709251010 BOTTLE in 1 CARTON (67457-925-10) / 100 mL in 1 BOTTLE (67457-925-00) 10 bottle2020-11-130000-00-00NoNoCurrent