FDA.reportPublic FDA data

Dexmedetomidine

Product NDC
67457-251
11-digit product format
674570251
Labeler code
67457
Product ID
67457-251_afa561b9-9d6c-47b3-87e6-8d049597a0ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dexmedetomidine
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
ANDA202881
Marketing category
ANDA
Marketing start
2014-08-18
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dexmedetomidine
Listing expiration
2027-12-31

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
67457-251-00Dexmedetomidine2 mL in 1 VIAL, GLASSINJECTION, SOLUTION, CONCENTRATE221
67457-251-02Dexmedetomidine25 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE2521

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-251-00ML - Milliliter67457-25129ed2165-551f-4979-bd68-ef6f9aa04dd012014-09-03
67457-251-02ML - Milliliter67457-25116ddaf7e-3658-4af8-9999-ba48c57f965f12014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXMEDETOMIDINE HYDROCHLORIDEACTIVE INGREDIENT1018WH7F9IDEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [MYLAN INSTITUTIONAL LLC]7
DEXMEDETOMIDINEACTIVE MOIETY67VB76HONODEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [MYLAN INSTITUTIONAL LLC]7
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XDEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [MYLAN INSTITUTIONAL LLC]7
WATERINACTIVE INGREDIENT059QF0KO0RDEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [MYLAN INSTITUTIONAL LLC]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-251DEXMEDETOMIDINE INJECTION, SOLUTION, CONCENTRATE [MYLAN INSTITUTIONAL LLC]20Current NDC, Legacy NDC, 2 package rows20250410_ebdfe2e8-30ca-4f18-935a-41bcbbce4937.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309710dexmedeTOMIDine HCl 200 MCG in 2 ML InjectionPSNebdfe2e8-30ca-4f18-935a-41bcbbce493721
3097102 ML dexmedetomidine 0.1 MG/ML InjectionSCDebdfe2e8-30ca-4f18-935a-41bcbbce493721
309710dexmedetomidine (as dexmedetomidine HCl) 0.1 MG/ML per 2 ML InjectionSYebdfe2e8-30ca-4f18-935a-41bcbbce493721
309710dexmedetomidine (as dexmedetomidine HCl) 100 MCG/ML InjectionSYebdfe2e8-30ca-4f18-935a-41bcbbce493721

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67457-251-00674570251002 mL in 1 VIAL, GLASS2 mlHistorical
67457-251-026745702510225 VIAL, GLASS in 1 CARTON (67457-251-02) / 2 mL in 1 VIAL, GLASS (67457-251-00) 2014-08-180000-00-00NoNoCurrent