FDA.reportPublic FDA data

Dexmedetomidine

Product NDC
83634-600
11-digit product format
836340600
Labeler code
83634
Product ID
83634-600_3e30e931-4d42-465c-9e4b-cd3137ba5fe2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dexmedetomidine
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Avenacy Inc.
Application
ANDA209065
Marketing category
ANDA
Marketing start
2024-03-15
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
83634-600-02Dexmedetomidine25 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE251
83634-600-41Dexmedetomidine2 mL in 1 VIALINJECTION, SOLUTION, CONCENTRATE21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83634-600DEXMEDETOMIDINE INJECTION, SOLUTION, CONCENTRATE [AVENACY INC.]1Current NDC, 2 package rows20240316_eee6145b-d83f-4596-92d3-733934d8a3a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309710dexmedeTOMIDine HCl 200 MCG in 2 ML InjectionPSNeee6145b-d83f-4596-92d3-733934d8a3a41
3097102 ML dexmedetomidine 0.1 MG/ML InjectionSCDeee6145b-d83f-4596-92d3-733934d8a3a41
309710dexmedetomidine (as dexmedetomidine HCl) 0.1 MG/ML per 2 ML InjectionSYeee6145b-d83f-4596-92d3-733934d8a3a41
309710dexmedetomidine (as dexmedetomidine HCl) 100 MCG/ML InjectionSYeee6145b-d83f-4596-92d3-733934d8a3a41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83634-600-028363406000225 VIAL in 1 CARTON (83634-600-02) / 2 mL in 1 VIAL (83634-600-41) 25 vial2024-03-15NoNoCurrent
83634-600-41836340600412 mL in 1 VIAL2 mlHistorical