Dexmedetomidine hydrochloride

Product NDC
71872-7030
11-digit product format
718727030
Labeler code
71872
Product ID
71872-7030_fd163116-8854-9366-e053-6394a90a00b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexmedetomidine hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Medical Purchasing Solutions, LLC
Application
ANDA204023
Marketing category
ANDA
Marketing start
2016-12-21
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
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 HYDROCHLORIDE100 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1018WH7F9I
Rxcui309710

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
71872-7030-1Dexmedetomidine hydrochloride2 mL in 1 VIALINJECTION, SOLUTION22
71872-7030-1Dexmedetomidine hydrochloride1 in 1 BAGINJECTION, SOLUTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71872-7030DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [MEDICAL PURCHASING SOLUTIONS, LLC]2Current NDC, Legacy NDC, 2 package rows20230602_a2666c50-3b55-1380-e053-2a95a90aea58.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309710dexmedeTOMIDine HCl 200 MCG in 2 ML InjectionPSNa2666c50-3b55-1380-e053-2a95a90aea582
3097102 ML dexmedetomidine 0.1 MG/ML InjectionSCDa2666c50-3b55-1380-e053-2a95a90aea582
309710dexmedetomidine (as dexmedetomidine HCl) 0.1 MG/ML per 2 ML InjectionSYa2666c50-3b55-1380-e053-2a95a90aea582
309710dexmedetomidine (as dexmedetomidine HCl) 100 MCG/ML InjectionSYa2666c50-3b55-1380-e053-2a95a90aea582

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71872-7030-1718727030011 VIAL in 1 BAG (71872-7030-1) / 2 mL in 1 VIAL1 vial2020-02-280000-00-00NoNoCurrent