FDA.reportPublic FDA data

DEXMEDETOMIDINE HYDROCHLORIDE

Product NDC
43598-975
11-digit product format
435980975
Labeler code
43598
Product ID
43598-975_5785a11f-7784-4ae0-8029-f50b782eaf4a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEXMEDETOMIDINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Dr.Reddy's Laboratories Inc
Application
ANDA209307
Marketing category
ANDA
Marketing start
2020-08-17
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
Rxcui1718906, 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
43598-975-11DEXMEDETOMIDINE HYDROCHLORIDE100 mL in 1 VIALINJECTION, SOLUTION1003
43598-975-58DEXMEDETOMIDINE HYDROCHLORIDE10 in 1 CARTONINJECTION, SOLUTION103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-975DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [DR.REDDY'S LABORATORIES INC]3Current NDC, Legacy NDC, 2 package rows20240627_d174c19d-56f1-4ef4-087c-23c26db8e40b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1718906dexmedeTOMIDine HCl 200 MCG in 50 ML InjectionPSNd174c19d-56f1-4ef4-087c-23c26db8e40b3
1718909dexmedeTOMIDine HCl 400 MCG in 100 ML InjectionPSNd174c19d-56f1-4ef4-087c-23c26db8e40b3
1718909100 ML dexmedetomidine 0.004 MG/ML InjectionSCDd174c19d-56f1-4ef4-087c-23c26db8e40b3
171890650 ML dexmedetomidine 0.004 MG/ML InjectionSCDd174c19d-56f1-4ef4-087c-23c26db8e40b3
1718906dexmedetomidine (as dexmedetomidine HCl) 200 MCG per 50 ML InjectionSYd174c19d-56f1-4ef4-087c-23c26db8e40b3
1718909dexmedetomidine (as dexmedetomidine HCl) 400 MCG per 100 ML InjectionSYd174c19d-56f1-4ef4-087c-23c26db8e40b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-975-1143598097511100 mL in 1 VIAL100 mlHistorical
43598-975-584359809755810 VIAL in 1 CARTON (43598-975-58) / 100 mL in 1 VIAL (43598-975-11) 10 vial2020-08-170000-00-00NoNoCurrent