FDA.reportPublic FDA data

Dexmedetomidine Hydrochloride

Product NDC
68083-238
11-digit product format
680830238
Labeler code
68083
Product ID
68083-238_29930c5a-6908-4686-aa11-1560abca3c7f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexmedetomidine Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Gland Pharma Limited
Application
ANDA209307
Marketing category
ANDA
Marketing start
2020-06-03
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
Dexmedetomidine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXMEDETOMIDINE HYDROCHLORIDE4 ug/mL

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
68083-238-20Dexmedetomidine Hydrochloride50 mL in 1 VIALINJECTION5013
68083-238-20Dexmedetomidine Hydrochloride20 in 1 CARTONINJECTION2013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-238DEXMEDETOMIDINE HYDROCHLORIDE INJECTION [GLAND PHARMA LIMITED]11Current NDC, Legacy NDC, 2 package rows20241222_f307de7e-a9ab-4734-abb7-66b4e112bc51.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1718906dexmedeTOMIDine HCl 200 MCG in 50 ML InjectionPSNf307de7e-a9ab-4734-abb7-66b4e112bc5113
1718909dexmedeTOMIDine HCl 400 MCG in 100 ML InjectionPSNf307de7e-a9ab-4734-abb7-66b4e112bc5113
1718909100 ML dexmedetomidine 0.004 MG/ML InjectionSCDf307de7e-a9ab-4734-abb7-66b4e112bc5113
171890650 ML dexmedetomidine 0.004 MG/ML InjectionSCDf307de7e-a9ab-4734-abb7-66b4e112bc5113
1718906dexmedetomidine (as dexmedetomidine HCl) 200 MCG per 50 ML InjectionSYf307de7e-a9ab-4734-abb7-66b4e112bc5113
1718909dexmedetomidine (as dexmedetomidine HCl) 400 MCG per 100 ML InjectionSYf307de7e-a9ab-4734-abb7-66b4e112bc5113

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68083-238-206808302382020 VIAL in 1 CARTON (68083-238-20) / 50 mL in 1 VIAL20 vial2020-06-030000-00-00NoNoCurrent