FDA.reportPublic FDA data

DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE

Product NDC
0781-3493
11-digit product format
007813493
Labeler code
0781
Product ID
0781-3493_fdf227d9-008e-60f8-e053-6294a90af5c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Sandoz Inc.
Application
ANDA209065
Marketing category
ANDA
Marketing start
2020-06-12
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 0.9% 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0781-3493-952021-08-03C16284748780-1c7ccaba7-1170-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION. DEXMEDETOMIDINE HYDROCHLORIDE in SODIUM CHLORIDE injection, for intravenous use Initial U.S. Approval: 1999
0781-3493-952021-07-23C16284748780-1c7ccaba7-1170-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION. DEXMEDETOMIDINE HYDROCHLORIDE in SODIUM CHLORIDE injection, for intravenous use Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-3493-95DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE10 in 1 CARTONINJECTION1015
0781-3493-95DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE20 mL in 1 VIALINJECTION2015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-3493DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION [SANDOZ INC.]15Current NDC, Legacy NDC, 2 package rows20230613_809e8f77-390f-4cc8-8c8a-4f67a249c9df.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1718906dexmedeTOMIDine HCl 200 MCG in 50 ML InjectionPSN809e8f77-390f-4cc8-8c8a-4f67a249c9df15
1718909dexmedeTOMIDine HCl 400 MCG in 100 ML InjectionPSN809e8f77-390f-4cc8-8c8a-4f67a249c9df15
1718900dexmedeTOMIDine HCl 80 MCG in 20 ML InjectionPSN809e8f77-390f-4cc8-8c8a-4f67a249c9df15
1718909100 ML dexmedetomidine 0.004 MG/ML InjectionSCD809e8f77-390f-4cc8-8c8a-4f67a249c9df15
171890020 ML dexmedetomidine 0.004 MG/ML InjectionSCD809e8f77-390f-4cc8-8c8a-4f67a249c9df15
171890650 ML dexmedetomidine 0.004 MG/ML InjectionSCD809e8f77-390f-4cc8-8c8a-4f67a249c9df15
1718906dexmedetomidine (as dexmedetomidine HCl) 200 MCG per 50 ML InjectionSY809e8f77-390f-4cc8-8c8a-4f67a249c9df15
1718909dexmedetomidine (as dexmedetomidine HCl) 400 MCG per 100 ML InjectionSY809e8f77-390f-4cc8-8c8a-4f67a249c9df15
1718900dexmedetomidine (as dexmedetomidine HCl) 80 MCG per 20 ML InjectionSY809e8f77-390f-4cc8-8c8a-4f67a249c9df15
1718900dexmedeTOMIDine HCl 80 MCG in 20 ML InjectionPSN42caba25-dd87-040c-e063-6294a90a7a121
171890020 ML dexmedetomidine 0.004 MG/ML InjectionSCD42caba25-dd87-040c-e063-6294a90a7a121
1718900dexmedetomidine (as dexmedetomidine HCl) 80 MCG per 20 ML InjectionSY42caba25-dd87-040c-e063-6294a90a7a121

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-3493-950078134939510 VIAL in 1 CARTON (0781-3493-95) / 20 mL in 1 VIAL10 vial2020-06-120000-00-00NoNoCurrent