FDA.reportPublic FDA data

Dexmedetomidine HCl

Product NDC
0143-9532
11-digit product format
001439532
Labeler code
0143
Product ID
0143-9532_8cb1c4c8-48b4-471f-b443-5f03896a3fb7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexmedetomidine HCl
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA205046
Marketing category
ANDA
Marketing start
2017-04-26
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 HCl
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
0143-9532-01Dexmedetomidine HCl2 mL in 1 VIALINJECTION215
0143-9532-25Dexmedetomidine HCl25 in 1 CARTONINJECTION2515

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9532-01ML - Milliliter0143-9532649726b5-ffea-49e7-8dca-f3804bd9784c12017-09-11
0143-9532-25ML - Milliliter0143-9532290c4716-5823-467c-bdab-0b1b62c9e1fb12017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9532DEXMEDETOMIDINE HCL INJECTION [HIKMA PHARMACEUTICALS USA INC.]14Current NDC, Legacy NDC, 2 package rows20230509_de6f01a2-9f2d-4c68-9c02-06643704acb1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309710dexmedeTOMIDine HCl 200 MCG in 2 ML InjectionPSNde6f01a2-9f2d-4c68-9c02-06643704acb115
3097102 ML dexmedetomidine 0.1 MG/ML InjectionSCDde6f01a2-9f2d-4c68-9c02-06643704acb115
309710dexmedetomidine (as dexmedetomidine HCl) 0.1 MG/ML per 2 ML InjectionSYde6f01a2-9f2d-4c68-9c02-06643704acb115
309710dexmedetomidine (as dexmedetomidine HCl) 100 MCG/ML InjectionSYde6f01a2-9f2d-4c68-9c02-06643704acb115
309710dexmedeTOMIDine HCl 200 MCG in 2 ML InjectionPSNada70a68-3e52-4b94-e053-2995a90aa1e02
3097102 ML dexmedetomidine 0.1 MG/ML InjectionSCDada70a68-3e52-4b94-e053-2995a90aa1e02
309710dexmedetomidine (as dexmedetomidine HCl) 0.1 MG/ML per 2 ML InjectionSYada70a68-3e52-4b94-e053-2995a90aa1e02
309710dexmedetomidine (as dexmedetomidine HCl) 100 MCG/ML InjectionSYada70a68-3e52-4b94-e053-2995a90aa1e02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9532-01001439532012 mL in 1 VIAL2 mlHistorical
0143-9532-250014395322525 VIAL in 1 CARTON (0143-9532-25) / 2 mL in 1 VIAL (0143-9532-01) 25 vial2017-04-260000-00-00NoNoCurrent