FDA.reportPublic FDA data

DEXMEDETOMIDINE HYDROCHLORIDE

Product NDC
0338-9557
11-digit product format
003389557
Labeler code
0338
Product ID
0338-9557_594e9faa-bc32-42e0-9c0a-8fa9460b1e24
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEXMEDETOMIDINE HYDROCHLORIDE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Company
Application
ANDA208532
Marketing category
ANDA
Marketing start
2018-08-21
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0338-9557-12DEXMEDETOMIDINE HYDROCHLORIDE100 mL in 1 BAGINJECTION10013
0338-9557-12DEXMEDETOMIDINE HYDROCHLORIDE12 in 1 CARTONINJECTION1213

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-9557-12ML - Milliliter0338-955727dde1e4-b95b-4318-8006-cf598d5e657112018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-9557DEXMEDETOMIDINE HYDROCHLORIDE INJECTION [BAXTER HEALTHCARE COMPANY]12Current NDC, Legacy NDC, 2 package rows20250516_8ccb45a7-8290-469c-9644-a4dca967d88f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1718906dexmedeTOMIDine HCl 200 MCG in 50 ML InjectionPSN8ccb45a7-8290-469c-9644-a4dca967d88f13
1718909dexmedeTOMIDine HCl 400 MCG in 100 ML InjectionPSN8ccb45a7-8290-469c-9644-a4dca967d88f13
1718909100 ML dexmedetomidine 0.004 MG/ML InjectionSCD8ccb45a7-8290-469c-9644-a4dca967d88f13
171890650 ML dexmedetomidine 0.004 MG/ML InjectionSCD8ccb45a7-8290-469c-9644-a4dca967d88f13
1718906dexmedetomidine (as dexmedetomidine HCl) 200 MCG per 50 ML InjectionSY8ccb45a7-8290-469c-9644-a4dca967d88f13
1718909dexmedetomidine (as dexmedetomidine HCl) 400 MCG per 100 ML InjectionSY8ccb45a7-8290-469c-9644-a4dca967d88f13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0338-9557-120033895571212 BAG in 1 CARTON (0338-9557-12) / 100 mL in 1 BAG12 bag2018-08-210000-00-00NoNoCurrent