FDA.reportPublic FDA data

Dexmedetomidine Hydrochloride in Sodium Chloride

Product NDC
68094-047
11-digit product format
680940047
Labeler code
68094
Product ID
68094-047_721350a6-f9ae-4c06-b8b5-41169d7cd43e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexmedetomidine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Precision Dose, Inc.
Application
ANDA212857
Marketing category
ANDA
Marketing start
2020-11-23
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 in Sodium Chloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXMEDETOMIDINE HYDROCHLORIDE4 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1018WH7F9I
Rxcui1718900, 1718906, 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
68094-047-01Dexmedetomidine Hydrochloride in Sodium Chloride20 mL in 1 VIALINJECTION, SOLUTION206
68094-047-10Dexmedetomidine Hydrochloride in Sodium Chloride10 in 1 CARTONINJECTION, SOLUTION106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-047DEXMEDETOMIDINE HYDROCHLORIDE IN SODIUM CHLORIDE (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION [PRECISION DOSE, INC.]5Current NDC, Legacy NDC, 2 package rows20231222_e9d5c989-ebf6-4377-9c6e-7aef848a03a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1718906dexmedeTOMIDine HCl 200 MCG in 50 ML InjectionPSNe9d5c989-ebf6-4377-9c6e-7aef848a03a16
1718909dexmedeTOMIDine HCl 400 MCG in 100 ML InjectionPSNe9d5c989-ebf6-4377-9c6e-7aef848a03a16
1718900dexmedeTOMIDine HCl 80 MCG in 20 ML InjectionPSNe9d5c989-ebf6-4377-9c6e-7aef848a03a16
1718909100 ML dexmedetomidine 0.004 MG/ML InjectionSCDe9d5c989-ebf6-4377-9c6e-7aef848a03a16
171890020 ML dexmedetomidine 0.004 MG/ML InjectionSCDe9d5c989-ebf6-4377-9c6e-7aef848a03a16
171890650 ML dexmedetomidine 0.004 MG/ML InjectionSCDe9d5c989-ebf6-4377-9c6e-7aef848a03a16
1718906dexmedetomidine (as dexmedetomidine HCl) 200 MCG per 50 ML InjectionSYe9d5c989-ebf6-4377-9c6e-7aef848a03a16
1718909dexmedetomidine (as dexmedetomidine HCl) 400 MCG per 100 ML InjectionSYe9d5c989-ebf6-4377-9c6e-7aef848a03a16
1718900dexmedetomidine (as dexmedetomidine HCl) 80 MCG per 20 ML InjectionSYe9d5c989-ebf6-4377-9c6e-7aef848a03a16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68094-047-016809400470120 mL in 1 VIAL20 mlHistorical
68094-047-106809400471010 VIAL in 1 CARTON (68094-047-10) / 20 mL in 1 VIAL (68094-047-01) 10 vial2020-11-230000-00-00NoNoCurrent