FDA.reportPublic FDA data

Dexmedetomidine

Product NDC
55150-209
11-digit product format
551500209
Labeler code
55150
Product ID
55150-209_b08abc07-bacd-453d-b6c3-cb6fa9eff79b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexmedetomidine
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Eugia US LLC
Application
ANDA205867
Marketing category
ANDA
Marketing start
2016-03-17
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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXMEDETOMIDINE HYDROCHLORIDE100 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1018WH7F9I
Rxcui309710, 1718906, 1718909

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
55150-209-02Dexmedetomidine2 mL in 1 VIALINJECTION, SOLUTION215
55150-209-02Dexmedetomidine25 in 1 CARTONINJECTION, SOLUTION2515

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-209-02ML - Milliliter55150-2090b1cdc8d-b21e-40b3-a84f-1899c36a88bb12016-06-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-209DEXMEDETOMIDINE INJECTION, SOLUTION DEXMEDETOMIDINE HYDROCHLORIDE (DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE) INJECTION, SOLUTION [EUGIA US LLC]12Current NDC, Legacy NDC, 2 package rows20230608_8c162541-986b-4b30-866c-b2631ba2c975.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309710dexmedeTOMIDine HCl 200 MCG in 2 ML InjectionPSN8c162541-986b-4b30-866c-b2631ba2c97515
1718906dexmedeTOMIDine HCl 200 MCG in 50 ML InjectionPSN8c162541-986b-4b30-866c-b2631ba2c97515
1718909dexmedeTOMIDine HCl 400 MCG in 100 ML InjectionPSN8c162541-986b-4b30-866c-b2631ba2c97515
1718909100 ML dexmedetomidine 0.004 MG/ML InjectionSCD8c162541-986b-4b30-866c-b2631ba2c97515
3097102 ML dexmedetomidine 0.1 MG/ML InjectionSCD8c162541-986b-4b30-866c-b2631ba2c97515
171890650 ML dexmedetomidine 0.004 MG/ML InjectionSCD8c162541-986b-4b30-866c-b2631ba2c97515
309710dexmedetomidine (as dexmedetomidine HCl) 0.1 MG/ML per 2 ML InjectionSY8c162541-986b-4b30-866c-b2631ba2c97515
309710dexmedetomidine (as dexmedetomidine HCl) 100 MCG/ML InjectionSY8c162541-986b-4b30-866c-b2631ba2c97515
1718906dexmedetomidine (as dexmedetomidine HCl) 200 MCG per 50 ML InjectionSY8c162541-986b-4b30-866c-b2631ba2c97515
1718909dexmedetomidine (as dexmedetomidine HCl) 400 MCG per 100 ML InjectionSY8c162541-986b-4b30-866c-b2631ba2c97515
309710dexmedeTOMIDine HCl 200 MCG in 2 ML InjectionPSNa268e759-9a3e-1d7b-e053-2a95a90a335b3
3097102 ML dexmedetomidine 0.1 MG/ML InjectionSCDa268e759-9a3e-1d7b-e053-2a95a90a335b3
309710dexmedetomidine (as dexmedetomidine HCl) 0.1 MG/ML per 2 ML InjectionSYa268e759-9a3e-1d7b-e053-2a95a90a335b3
309710dexmedetomidine (as dexmedetomidine HCl) 100 MCG/ML InjectionSYa268e759-9a3e-1d7b-e053-2a95a90a335b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55150-209-025515002090225 VIAL in 1 CARTON (55150-209-02) / 2 mL in 1 VIAL25 vial2016-03-170000-00-00NoNoCurrent