FDA.reportPublic FDA data

DEXMEDETOMIDINE HYDROCHLORIDE

Product NDC
52536-125
11-digit product format
525360125
Labeler code
52536
Product ID
52536-125_f550d2ba-49ac-4a3b-95db-692b468af479
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dexmedetomidine hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Wilshire Pharmaceuticals, Inc.
Application
ANDA212791
Marketing category
ANDA
Marketing start
2025-01-30
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
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
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52536-125-01DEXMEDETOMIDINE HYDROCHLORIDE50 mL in 1 BOTTLEINJECTION501
52536-125-10DEXMEDETOMIDINE HYDROCHLORIDE10 in 1 CARTONINJECTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52536-125-01ML - Milliliter52536-1253ae77fe2-b946-4256-a092-a59015666ce812025-05-14
52536-125-10ML - Milliliter52536-12537c4a099-d5cb-49d8-90a8-592a00a09b6f12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52536-125DEXMEDETOMIDINE HYDROCHLORIDE INJECTION [WILSHIRE PHARMACEUTICALS, INC.]1Current NDC, 2 package rows20250302_f550d2ba-49ac-4a3b-95db-692b468af479.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1718906dexmedeTOMIDine HCl 200 MCG in 50 ML InjectionPSNf550d2ba-49ac-4a3b-95db-692b468af4791
1718909dexmedeTOMIDine HCl 400 MCG in 100 ML InjectionPSNf550d2ba-49ac-4a3b-95db-692b468af4791
1718909100 ML dexmedetomidine 0.004 MG/ML InjectionSCDf550d2ba-49ac-4a3b-95db-692b468af4791
171890650 ML dexmedetomidine 0.004 MG/ML InjectionSCDf550d2ba-49ac-4a3b-95db-692b468af4791
1718906dexmedetomidine (as dexmedetomidine HCl) 200 MCG per 50 ML InjectionSYf550d2ba-49ac-4a3b-95db-692b468af4791
1718909dexmedetomidine (as dexmedetomidine HCl) 400 MCG per 100 ML InjectionSYf550d2ba-49ac-4a3b-95db-692b468af4791

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
52536-125-015253601250150 mL in 1 BOTTLE50 mlHistorical
52536-125-105253601251010 BOTTLE in 1 CARTON (52536-125-10) / 50 mL in 1 BOTTLE (52536-125-01) 10 bottle2025-01-30NoNoHistorical