FDA.reportPublic FDA data

Dexmedetomidine Hydrochloride

Product NDC
63323-671
11-digit product format
633230671
Labeler code
63323
Product ID
63323-671_27411591-44a1-44c4-89c3-dd8c2687f0e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexmedetomidine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA208129
Marketing category
ANDA
Marketing start
2019-05-13
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dexmedetomidine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXMEDETOMIDINE HYDROCHLORIDE4 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1018WH7F9I
Rxcui1718900, 1718906, 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
63323-671-00Dexmedetomidine Hydrochloride10 in 1 CARTONINJECTION, SOLUTION105
63323-671-01Dexmedetomidine Hydrochloride100 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION1005
63323-671-02Dexmedetomidine Hydrochloride20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION205
63323-671-05Dexmedetomidine Hydrochloride50 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION505
63323-671-20Dexmedetomidine Hydrochloride10 in 1 CARTONINJECTION, SOLUTION105
63323-671-50Dexmedetomidine Hydrochloride25 in 1 CARTONINJECTION, SOLUTION255

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-671-00ML - Milliliter63323-67140beb3f6-7bc2-48d6-933f-201ee2763ffc12019-06-19
63323-671-01ML - Milliliter63323-67159fcd655-1d1c-4b59-af8b-d0d4cdc5536b12019-06-19
63323-671-02ML - Milliliter63323-671bb1dbc22-6c23-4e76-9e6e-4e656842f2f712019-06-19
63323-671-05ML - Milliliter63323-6716fa96e9c-0fb2-4df4-9be0-b5ffb28f88c212019-06-19
63323-671-20ML - Milliliter63323-6717ef08756-32f8-4501-9653-40be400a983c12019-06-19
63323-671-50ML - Milliliter63323-671ffa8f1d9-5954-470e-8537-30660fbece3f12019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-671DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]5Current NDC, Legacy NDC, 6 package rows20240518_4d5d2294-89a0-4b6f-aa00-d39a0393b6a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1718906dexmedeTOMIDine HCl 200 MCG in 50 ML InjectionPSN4d5d2294-89a0-4b6f-aa00-d39a0393b6a85
1718909dexmedeTOMIDine HCl 400 MCG in 100 ML InjectionPSN4d5d2294-89a0-4b6f-aa00-d39a0393b6a85
1718900dexmedeTOMIDine HCl 80 MCG in 20 ML InjectionPSN4d5d2294-89a0-4b6f-aa00-d39a0393b6a85
1718909100 ML dexmedetomidine 0.004 MG/ML InjectionSCD4d5d2294-89a0-4b6f-aa00-d39a0393b6a85
171890020 ML dexmedetomidine 0.004 MG/ML InjectionSCD4d5d2294-89a0-4b6f-aa00-d39a0393b6a85
171890650 ML dexmedetomidine 0.004 MG/ML InjectionSCD4d5d2294-89a0-4b6f-aa00-d39a0393b6a85
1718906dexmedetomidine (as dexmedetomidine HCl) 200 MCG per 50 ML InjectionSY4d5d2294-89a0-4b6f-aa00-d39a0393b6a85
1718909dexmedetomidine (as dexmedetomidine HCl) 400 MCG per 100 ML InjectionSY4d5d2294-89a0-4b6f-aa00-d39a0393b6a85
1718900dexmedetomidine (as dexmedetomidine HCl) 80 MCG per 20 ML InjectionSY4d5d2294-89a0-4b6f-aa00-d39a0393b6a85

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-671-006332306710010 BOTTLE, GLASS in 1 CARTON (63323-671-00) / 100 mL in 1 BOTTLE, GLASS (63323-671-01) 2019-05-130000-00-00NoNoCurrent
63323-671-0163323067101100 mL in 1 BOTTLE, GLASS100 mlHistorical
63323-671-026332306710220 mL in 1 VIAL, SINGLE-DOSE20 mlHistorical
63323-671-056332306710550 mL in 1 BOTTLE, GLASS50 mlHistorical
63323-671-206332306712010 VIAL, SINGLE-DOSE in 1 CARTON (63323-671-20) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-671-02) 2019-05-130000-00-00NoNoCurrent
63323-671-506332306715025 BOTTLE, GLASS in 1 CARTON (63323-671-50) / 50 mL in 1 BOTTLE, GLASS (63323-671-05) 2019-05-130000-00-00NoNoCurrent