FDA.reportPublic FDA data

DEXMEDETOMIDINE HYDROCHLORIDE

Product NDC
43066-565
11-digit product format
430660565
Labeler code
43066
Product ID
43066-565_18385e15-6a52-4aec-b152-1cc136179bf4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEXMEDETOMIDINE HYDROCHLORIDE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Company
Application
ANDA208532
Marketing category
ANDA
Marketing start
2019-08-27
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
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 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
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
acae4bed-c293-9f7e-61b9-d68b8475ed3aProduct name220230104
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
536fa340-f745-6c4e-1ad7-a3c414722bccProduct name920170706
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43066-565-122022-11-14C16284748780-1d6a99b39-9189-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION. DEXMEDETOMIDINE HYDROCHLORIDE in 0.9% sodium chloride injection, for intravenous use Initial U.S. Approval: 1999
43066-565-122022-01-28C16284748780-1d6a99b39-9189-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION. DEXMEDETOMIDINE HYDROCHLORIDE in 0.9% sodium chloride injection, for intravenous use Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43066-565-12DEXMEDETOMIDINE HYDROCHLORIDE12 in 1 CARTONINJECTION1212
43066-565-12DEXMEDETOMIDINE HYDROCHLORIDE100 mL in 1 BAGINJECTION10012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43066-565DEXMEDETOMIDINE HYDROCHLORIDE INJECTION [BAXTER HEALTHCARE COMPANY]11Current NDC, Legacy NDC, 2 package rows20250515_32242f34-6e2b-4098-bd8e-3d55162f31b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1718906dexmedeTOMIDine HCl 200 MCG in 50 ML InjectionPSN32242f34-6e2b-4098-bd8e-3d55162f31b512
1718909dexmedeTOMIDine HCl 400 MCG in 100 ML InjectionPSN32242f34-6e2b-4098-bd8e-3d55162f31b512
1718909100 ML dexmedetomidine 0.004 MG/ML InjectionSCD32242f34-6e2b-4098-bd8e-3d55162f31b512
171890650 ML dexmedetomidine 0.004 MG/ML InjectionSCD32242f34-6e2b-4098-bd8e-3d55162f31b512
1718906dexmedetomidine (as dexmedetomidine HCl) 200 MCG per 50 ML InjectionSY32242f34-6e2b-4098-bd8e-3d55162f31b512
1718909dexmedetomidine (as dexmedetomidine HCl) 400 MCG per 100 ML InjectionSY32242f34-6e2b-4098-bd8e-3d55162f31b512

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43066-565-124306605651212 BAG in 1 CARTON (43066-565-12) / 100 mL in 1 BAG12 bag2019-08-270000-00-00NoNoCurrent