FDA.reportPublic FDA data

Dexmedetomidine Hydrochloride

Product NDC
36000-262
11-digit product format
360000262
Labeler code
36000
Product ID
36000-262_f0a53e8e-e8cc-4b2d-b8f0-2d99b01f6cc2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dexmedetomidine hydrochloride
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
ANDA208103
Marketing category
ANDA
Marketing start
2026-04-16
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
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 HYDROCHLORIDE100 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1018WH7F9I
Rxcui309710

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
36000-262-01Dexmedetomidine Hydrochloride2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE29
36000-262-05Dexmedetomidine Hydrochloride5 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE59
36000-262-10Dexmedetomidine Hydrochloride10 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE109
36000-262-25Dexmedetomidine Hydrochloride25 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE259

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309710dexmedeTOMIDine HCl 200 MCG in 2 ML InjectionPSN7d057255-22a1-4b69-ad7c-7337fac8e9939
3097102 ML dexmedetomidine 0.1 MG/ML InjectionSCD7d057255-22a1-4b69-ad7c-7337fac8e9939
309710dexmedetomidine (as dexmedetomidine HCl) 0.1 MG/ML per 2 ML InjectionSY7d057255-22a1-4b69-ad7c-7337fac8e9939
309710dexmedetomidine (as dexmedetomidine HCl) 100 MCG/ML InjectionSY7d057255-22a1-4b69-ad7c-7337fac8e9939

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
36000-262-01360000262012 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
36000-262-05360000262055 VIAL, SINGLE-DOSE in 1 CARTON (36000-262-05) / 2 mL in 1 VIAL, SINGLE-DOSE (36000-262-01) 2026-04-16NoNoCurrent
36000-262-103600002621010 VIAL, SINGLE-DOSE in 1 CARTON (36000-262-10) / 2 mL in 1 VIAL, SINGLE-DOSE (36000-262-01) 2026-04-16NoNoCurrent
36000-262-253600002622525 VIAL, SINGLE-DOSE in 1 CARTON (36000-262-25) / 2 mL in 1 VIAL, SINGLE-DOSE (36000-262-01) 2026-04-16NoNoCurrent