FDA.reportPublic FDA data

Dexmedetomidine Hydrochloride

Product NDC
0143-9526
11-digit product format
001439526
Labeler code
0143
Product ID
0143-9526_b39a45b9-3b3d-4719-8dfe-da16fd55ac10
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexmedetomidine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA206407
Marketing category
ANDA
Marketing start
2020-01-30
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXMEDETOMIDINE HYDROCHLORIDE4 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1018WH7F9I
Rxcui1718906, 1718909, 2396891

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
0143-9526-10Dexmedetomidine Hydrochloride10 in 1 CASEINJECTION, SOLUTION1015
0143-9526-10Dexmedetomidine Hydrochloride1 in 1 POUCHINJECTION, SOLUTION115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9526-10ML - Milliliter0143-952645679ad9-1066-459c-8971-f135edc61d5512021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9526DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]11Current NDC, Legacy NDC, 2 package rows20230509_ca67b379-f8b3-4d35-bf8a-235ecd4c4211.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2396891dexmedeTOMIDine 1000 MG in 250 mL InjectionPSNca67b379-f8b3-4d35-bf8a-235ecd4c421115
1718906dexmedeTOMIDine HCl 200 MCG in 50 ML InjectionPSNca67b379-f8b3-4d35-bf8a-235ecd4c421115
1718909dexmedeTOMIDine HCl 400 MCG in 100 ML InjectionPSNca67b379-f8b3-4d35-bf8a-235ecd4c421115
1718909100 ML dexmedetomidine 0.004 MG/ML InjectionSCDca67b379-f8b3-4d35-bf8a-235ecd4c421115
2396891250 ML dexmedetomidine 0.004 MG/ML InjectionSCDca67b379-f8b3-4d35-bf8a-235ecd4c421115
171890650 ML dexmedetomidine 0.004 MG/ML InjectionSCDca67b379-f8b3-4d35-bf8a-235ecd4c421115
1718906dexmedetomidine (as dexmedetomidine HCl) 200 MCG per 50 ML InjectionSYca67b379-f8b3-4d35-bf8a-235ecd4c421115
1718909dexmedetomidine (as dexmedetomidine HCl) 400 MCG per 100 ML InjectionSYca67b379-f8b3-4d35-bf8a-235ecd4c421115
2396891dexmedetomidine 0.004 MG/ML per 250 ML InjectionSYca67b379-f8b3-4d35-bf8a-235ecd4c421115
2396891dexmedetomidine 1000 MG per 250 ML InjectionSYca67b379-f8b3-4d35-bf8a-235ecd4c421115

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9526-100014395261010 POUCH in 1 CASE (0143-9526-10) / 1 BAG in 1 POUCH / 50 mL in 1 BAG10 pouch2020-01-300000-00-00NoNoCurrent