FDA.reportPublic FDA data

DEXMEDETOMIDINE HYDROCHLORIDE

Product NDC
71225-133
11-digit product format
712250133
Labeler code
71225
Product ID
71225-133_a58fa0dd-e910-4252-9a49-af607fd030ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dexmedetomidine hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Slayback Pharma LLC
Application
ANDA212791
Marketing category
ANDA
Marketing start
2021-10-20
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
71225-133-01DEXMEDETOMIDINE HYDROCHLORIDE100 mL in 1 BOTTLEINJECTION1007
71225-133-02DEXMEDETOMIDINE HYDROCHLORIDE8 in 1 CARTONINJECTION87

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71225-133-01ML - Milliliter71225-133325dd0be-225c-46d0-84ef-9b344c818d7412021-11-09
71225-133-02ML - Milliliter71225-1332ce75c16-01f0-47ac-8bd0-1144ed35a07a12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71225-133DEXMEDETOMIDINE HYDROCHLORIDE INJECTION [SLAYBACK PHARMA LLC]7Current NDC, Legacy NDC, 2 package rows20241222_f21d674a-7f5c-4143-82ae-83c43c503084.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1718906dexmedeTOMIDine HCl 200 MCG in 50 ML InjectionPSNf21d674a-7f5c-4143-82ae-83c43c5030847
1718909dexmedeTOMIDine HCl 400 MCG in 100 ML InjectionPSNf21d674a-7f5c-4143-82ae-83c43c5030847
1718909100 ML dexmedetomidine 0.004 MG/ML InjectionSCDf21d674a-7f5c-4143-82ae-83c43c5030847
171890650 ML dexmedetomidine 0.004 MG/ML InjectionSCDf21d674a-7f5c-4143-82ae-83c43c5030847
1718906dexmedetomidine (as dexmedetomidine HCl) 200 MCG per 50 ML InjectionSYf21d674a-7f5c-4143-82ae-83c43c5030847
1718909dexmedetomidine (as dexmedetomidine HCl) 400 MCG per 100 ML InjectionSYf21d674a-7f5c-4143-82ae-83c43c5030847

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71225-133-0171225013301100 mL in 1 BOTTLE100 mlHistorical
71225-133-02712250133028 BOTTLE in 1 CARTON (71225-133-02) / 100 mL in 1 BOTTLE (71225-133-01) 8 bottle2021-10-200000-00-00NoNoCurrent