FDA.reportPublic FDA data

DEXMEDETOMIDINE HYDROCHLORIDE

Product NDC
71225-126
11-digit product format
712250126
Labeler code
71225
Product ID
71225-126_027725dc-e468-446c-b702-ab0f8a9e3be5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dexmedetomidine hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Slayback Pharma LLC
Application
ANDA212791
Marketing category
ANDA
Marketing start
2019-12-06
Marketing end
2026-07-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DEXMEDETOMIDINE HYDROCHLORIDE

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
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71225-126-01DEXMEDETOMIDINE HYDROCHLORIDE20 mL in 1 VIALINJECTION2010
71225-126-02DEXMEDETOMIDINE HYDROCHLORIDE50 mL in 1 BOTTLEINJECTION5010
71225-126-03DEXMEDETOMIDINE HYDROCHLORIDE100 mL in 1 BOTTLEINJECTION10010
71225-126-04DEXMEDETOMIDINE HYDROCHLORIDE10 in 1 CARTONINJECTION1010
71225-126-05DEXMEDETOMIDINE HYDROCHLORIDE20 in 1 CARTONINJECTION2010
71225-126-06DEXMEDETOMIDINE HYDROCHLORIDE10 in 1 CARTONINJECTION1010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71225-126-02ML - Milliliter71225-12614c0e938-bf9f-4e78-a481-c74d96394de412020-01-03
71225-126-03ML - Milliliter71225-126139017dc-5564-490a-9dd4-5ce1f81ebc9312020-01-03
71225-126-05ML - Milliliter71225-126ed3ee683-648d-4ae3-b002-7abb76f6040412020-01-03
71225-126-06ML - Milliliter71225-126c8e2f3ab-fcab-4c14-ae1d-d65e9638adbb12020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71225-126DEXMEDETOMIDINE HYDROCHLORIDE INJECTION [SLAYBACK PHARMA LLC]10Current NDC, Legacy NDC, 6 package rows20250130_e5d28ed8-e427-4850-81aa-98702d3b6a5d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1718906dexmedeTOMIDine HCl 200 MCG in 50 ML InjectionPSNe5d28ed8-e427-4850-81aa-98702d3b6a5d10
1718909dexmedeTOMIDine HCl 400 MCG in 100 ML InjectionPSNe5d28ed8-e427-4850-81aa-98702d3b6a5d10
1718900dexmedeTOMIDine HCl 80 MCG in 20 ML InjectionPSNe5d28ed8-e427-4850-81aa-98702d3b6a5d10
1718909100 ML dexmedetomidine 0.004 MG/ML InjectionSCDe5d28ed8-e427-4850-81aa-98702d3b6a5d10
171890020 ML dexmedetomidine 0.004 MG/ML InjectionSCDe5d28ed8-e427-4850-81aa-98702d3b6a5d10
171890650 ML dexmedetomidine 0.004 MG/ML InjectionSCDe5d28ed8-e427-4850-81aa-98702d3b6a5d10
1718906dexmedetomidine (as dexmedetomidine HCl) 200 MCG per 50 ML InjectionSYe5d28ed8-e427-4850-81aa-98702d3b6a5d10
1718909dexmedetomidine (as dexmedetomidine HCl) 400 MCG per 100 ML InjectionSYe5d28ed8-e427-4850-81aa-98702d3b6a5d10
1718900dexmedetomidine (as dexmedetomidine HCl) 80 MCG per 20 ML InjectionSYe5d28ed8-e427-4850-81aa-98702d3b6a5d10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71225-126-017122501260120 mL in 1 VIAL20 mlHistorical
71225-126-027122501260250 mL in 1 BOTTLE50 mlHistorical
71225-126-0371225012603100 mL in 1 BOTTLE100 mlHistorical
71225-126-047122501260410 VIAL in 1 CARTON (71225-126-04) / 20 mL in 1 VIAL (71225-126-01) 10 vial2021-12-112026-07-31NoNoCurrent
71225-126-057122501260520 BOTTLE in 1 CARTON (71225-126-05) / 50 mL in 1 BOTTLE (71225-126-02) 20 bottle2019-12-062026-07-31NoNoCurrent
71225-126-067122501260610 BOTTLE in 1 CARTON (71225-126-06) / 100 mL in 1 BOTTLE (71225-126-03) 10 bottle2019-12-062026-07-31NoNoCurrent