Dexmedetomidine in Dextrose

Product NDC
44567-602
11-digit product format
445670602
Labeler code
44567
Product ID
44567-602_39d2f5dc-b34e-4c4b-9c54-3c8fb2c20589
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexmedetomidine
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
WG Critical Care, LLC
Application
NDA206628
Marketing category
NDA
Marketing start
2016-04-19
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 in Dextrose
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXMEDETOMIDINE HYDROCHLORIDE4 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1018WH7F9I
Rxcui1718906, 1718909, 1788947

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
44567-602-24Dexmedetomidine in Dextrose24 in 1 CARTONINJECTION2413
44567-602-24Dexmedetomidine in Dextrose50 mL in 1 BAGINJECTION5013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44567-602-24ML - Milliliter44567-60299081322-73b4-489e-b244-d2e8b6fecaa712018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44567-602DEXMEDETOMIDINE INJECTION, SOLUTION, CONCENTRATE DEXMEDETOMIDINE IN DEXTROSE (DEXMEDETOMIDINE) INJECTION [WG CRITICAL CARE, LLC]8Current NDC, Legacy NDC, 2 package rows20250315_0d2710f2-ee47-4114-ab5c-8dca74cdcb8d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44567-602-244456706022424 BAG in 1 CARTON (44567-602-24) / 50 mL in 1 BAG24 bag2018-10-180000-00-00NoNoCurrent