FDA.reportPublic FDA data

Dexmedetomidine

Product NDC
16729-239
11-digit product format
167290239
Labeler code
16729
Product ID
16729-239_2de0daf8-b7a3-1dca-e063-6394a90a4d0a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexmedetomidine
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Accord Healthcare Inc.
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
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
16729-239-30Dexmedetomidine2 mL in 1 VIALINJECTION, SOLUTION27
16729-239-93Dexmedetomidine25 in 1 CARTONINJECTION, SOLUTION257

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-239-30ML - Milliliter16729-239747cf6b5-670e-4407-bb61-dd9eadfb451e12017-03-06
16729-239-93ML - Milliliter16729-2390dc4b410-fbb0-4091-96b5-7ac89cf2988712017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-239DEXMEDETOMIDINE INJECTION, SOLUTION [ACCORD HEALTHCARE INC.]7Current NDC, Legacy NDC, 2 package rows20250213_2b9881f0-4a66-660f-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309710dexmedeTOMIDine HCl 200 MCG in 2 ML InjectionPSN2b9881f0-4a66-660f-e054-00144ff88e887
3097102 ML dexmedetomidine 0.1 MG/ML InjectionSCD2b9881f0-4a66-660f-e054-00144ff88e887
309710dexmedetomidine (as dexmedetomidine HCl) 0.1 MG/ML per 2 ML InjectionSY2b9881f0-4a66-660f-e054-00144ff88e887
309710dexmedetomidine (as dexmedetomidine HCl) 100 MCG/ML InjectionSY2b9881f0-4a66-660f-e054-00144ff88e887
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
16729-239-30167290239302 mL in 1 VIAL2 mlHistorical
16729-239-931672902399325 VIAL in 1 CARTON (16729-239-93) / 2 mL in 1 VIAL (16729-239-30) 25 vial2016-12-210000-00-00NoNoCurrent