Dexmedetomidine Hydrochloride (Page 7 of 7)

16 HOW SUPPLIED/STORAGE AND HANDLING

Dexmedetomidine Hydrochloride Injection is clear and colorless, and is available in a 100 mcg/mL strength in clear glass, multiple-dose vials as follows:

NDC No.

Strength

Package

44567-600-04

400 mcg/4 mL

4 vials/carton

44567-601-04

1000 mcg/10 mL

4 vials/carton

Dexmedetomidine Hydrochloride Injection is available in single-dose, single-port, ready-to-use flexible plastic infusion bags in a foil laminate overwrap as follows:

NDC No.

Strength

Package

44567-602-24

200 mcg/50 mL

24 bags/carton

44567-603-24

400 mcg/100 mL

24 bags/carton

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. It is recommended that the infusion bags be kept in the overwrap until ready to use. PROTECT INFUSION BAGS FROM FREEZING.

17 PATIENT COUNSELING INFORMATION

Advise patients, their families, or caregivers to report to their health care provider symptoms that occur within 48 hours after the administration of Dexmedetomidine HCl Injection such as:

Nervousness, agitation, and headaches which may be associated with an infusion lasting for more than 6 hours
Weakness, confusion, excessive sweating, weight loss, abdominal pain, salt cravings, diarrhea, constipation, dizziness or light-headedness

Important Potential Adverse Reactions Following Drug Discontinuation

Advise the patient, their families, or caregivers to contact their health care provider if they develop any of the following symptoms within 48 hours of receiving Dexmedetomidine HCl Injection: weakness, confusion, excessive sweating, weight loss, abdominal pain, salt cravings, diarrhea, constipation, dizziness or light-headedness.

Manufactured for:

WG Critical Care, LLC

Paramus, NJ 07652

Vials made in Finland

Bags made in Switzerland

U.S. Patent Numbers 9,649,296 and 9,717,796

PRINCIPAL DISPLAY PANEL

Dexmedetomidine HCl Injection 400 mcg/4 mL label image
(click image for full-size original)

NDC 44567-600-04

Dexmedetomidine HCl Injection

400 mcg/4 mL (100 mcg/mL)

Rx only WG Critical Care

PRINCIPAL DISPLAY PANEL

Dexmedetomidine HCl Injection 1000 mcg/10 mL label image
(click image for full-size original)

NDC 44567-601-04

Dexmedetomidine HCl Injection

1000 mcg/10 mL (100 mcg/mL)

Rx only WG Critical Care

Package/Label Display Panel

Dexmedetomidine HCl in 5% Dextrose Injection 200 mcg/50 mL bag image
(click image for full-size original)

NDC 44567-602-24 Rx only

Dexmedetomidine

HCl in 5% Dextrose Injection

200 mcg/50 mL (4 mcg/mL)

For Intravenous Use Only

Package/Label Display Panel

Dexmedetomidine HCl in 5% Dextrose Injection 400 mcg/100 mL label image
(click image for full-size original)

NDC 44567-603-24 Rx only

Dexmedetomidine

HCl in 5% Dextrose Injection

400 mcg/100 mL (4 mcg/mL)

For Intravenous Use Only

DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride injection, solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:44567-600
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXMEDETOMIDINE HYDROCHLORIDE (DEXMEDETOMIDINE) DEXMEDETOMIDINE 100 ug in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:44567-600-04 4 VIAL in 1 CARTON contains a VIAL
1 4 mL in 1 VIAL This package is contained within the CARTON (44567-600-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA206628 04/19/2016
DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride injection, solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:44567-601
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXMEDETOMIDINE HYDROCHLORIDE (DEXMEDETOMIDINE) DEXMEDETOMIDINE 100 ug in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:44567-601-04 4 VIAL in 1 CARTON contains a VIAL
1 10 mL in 1 VIAL This package is contained within the CARTON (44567-601-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA206628 04/19/2016
DEXMEDETOMIDINE HYDROCHLORIDE IN DEXTROSE dexmedetomidine hydrochloride injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:44567-602
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXMEDETOMIDINE HYDROCHLORIDE (DEXMEDETOMIDINE) DEXMEDETOMIDINE 4 ug in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:44567-602-24 24 BAG in 1 CARTON contains a BAG
1 50 mL in 1 BAG This package is contained within the CARTON (44567-602-24)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA206628 04/19/2016
DEXMEDETOMIDINE HYDROCHLORIDE IN DEXTROSE dexmedetomidine hydrochloride injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:44567-603
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXMEDETOMIDINE HYDROCHLORIDE (DEXMEDETOMIDINE) DEXMEDETOMIDINE 4 ug in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:44567-603-24 24 BAG in 1 CARTON contains a BAG
1 100 mL in 1 BAG This package is contained within the CARTON (44567-603-24)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA206628 04/19/2016
Labeler — WG Critical Care, LLC (829274633)

Revised: 12/2021 WG Critical Care, LLC

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