FDA.reportPublic FDA data

Dexmedetomidine Hydrochloride

Product NDC
66794-235
11-digit product format
667940235
Labeler code
66794
Product ID
66794-235_3f9d858b-fb67-25de-e063-6294a90a6776
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexmedetomidine Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Piramal Critical Care Inc
Application
ANDA209307
Marketing category
ANDA
Marketing start
2021-04-01
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXMEDETOMIDINE HYDROCHLORIDE4 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1018WH7F9I
Rxcui1718906, 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
66794-235-02Dexmedetomidine Hydrochloride100 mL in 1 VIALINJECTION1007
66794-235-41Dexmedetomidine Hydrochloride10 in 1 CARTONINJECTION107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66794-235-02ML - Milliliter66794-2356ce9e460-ab07-4673-b560-a38f20a268e112021-09-07
66794-235-41ML - Milliliter66794-23546740e25-2494-4500-9f47-891850e85bbf12021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66794-235DEXMEDETOMIDINE HYDROCHLORIDE INJECTION [PIRAMAL CRITICAL CARE INC]6Current NDC, Legacy NDC, 2 package rows20231227_c958aeb4-69ce-c3e2-e053-2a95a90a6d8d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1718906dexmedeTOMIDine HCl 200 MCG in 50 ML InjectionPSNc958aeb4-69ce-c3e2-e053-2a95a90a6d8d7
1718909dexmedeTOMIDine HCl 400 MCG in 100 ML InjectionPSNc958aeb4-69ce-c3e2-e053-2a95a90a6d8d7
1718909100 ML dexmedetomidine 0.004 MG/ML InjectionSCDc958aeb4-69ce-c3e2-e053-2a95a90a6d8d7
171890650 ML dexmedetomidine 0.004 MG/ML InjectionSCDc958aeb4-69ce-c3e2-e053-2a95a90a6d8d7
1718906dexmedetomidine (as dexmedetomidine HCl) 200 MCG per 50 ML InjectionSYc958aeb4-69ce-c3e2-e053-2a95a90a6d8d7
1718909dexmedetomidine (as dexmedetomidine HCl) 400 MCG per 100 ML InjectionSYc958aeb4-69ce-c3e2-e053-2a95a90a6d8d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66794-235-0266794023502100 mL in 1 VIAL100 mlHistorical
66794-235-416679402354110 VIAL in 1 CARTON (66794-235-41) / 100 mL in 1 VIAL (66794-235-02) 10 vial2021-04-010000-00-00NoNoCurrent