Dexmedetomidine HCl

Product NDC
71872-7218
11-digit product format
718727218
Labeler code
71872
Product ID
71872-7218_fad38944-bb6c-3562-e053-6394a90a3293
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexmedetomidine HCl
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Medical Purchasing Solutions, LLC
Application
ANDA205046
Marketing category
ANDA
Marketing start
2017-04-26
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 HCl
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
71872-7218-1Dexmedetomidine HCl2 mL in 1 VIALINJECTION22
71872-7218-1Dexmedetomidine HCl1 in 1 BAGINJECTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71872-7218DEXMEDETOMIDINE HCL INJECTION [MEDICAL PURCHASING SOLUTIONS, LLC]2Current NDC, Legacy NDC, 2 package rows20230505_ada70a68-3e52-4b94-e053-2995a90aa1e0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309710dexmedeTOMIDine HCl 200 MCG in 2 ML InjectionPSNada70a68-3e52-4b94-e053-2995a90aa1e02
3097102 ML dexmedetomidine 0.1 MG/ML InjectionSCDada70a68-3e52-4b94-e053-2995a90aa1e02
309710dexmedetomidine (as dexmedetomidine HCl) 0.1 MG/ML per 2 ML InjectionSYada70a68-3e52-4b94-e053-2995a90aa1e02
309710dexmedetomidine (as dexmedetomidine HCl) 100 MCG/ML InjectionSYada70a68-3e52-4b94-e053-2995a90aa1e02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71872-7218-1718727218011 VIAL in 1 BAG (71872-7218-1) / 2 mL in 1 VIAL1 vial2020-07-150000-00-00NoNoCurrent