DEXMEDETOMIDINE HYDROCHLORIDE (Page 7 of 7)

16 HOW SUPPLIED/STORAGE AND HANDLING

Do not use if product is discolored or if precipitate matter is present.

Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection (4 mcg/mL) is clear and colorless. The strength is based on the dexmedetomidine base. Discard unused portion.

Unit of Sale

Concentration

NDC 67457-924-50

Carton of 20 single-dose clear glass bottles

200 mcg/50 mL (4 mcg/mL)

NDC 67457-925-10

Carton of 10 single-dose clear glass bottles

400 mcg/100 mL (4 mcg/mL)

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Do not freeze.

17 PATIENT COUNSELING INFORMATION

Dexmedetomidine hydrochloride is indicated for short-term intravenous sedation. Dosage must be individualized and titrated to the desired clinical effect. Blood pressure, heart rate and oxygen levels will be monitored both continuously during the infusion of dexmedetomidine hydrochloride and as clinically appropriate after discontinuation.

When dexmedetomidine hydrochloride is infused for more than 6 hours, patients should be informed to report nervousness, agitation, and headaches that may occur for up to 48 hours.
Additionally, patients should be informed to report symptoms that may occur within 48 hours after the administration of dexmedetomidine hydrochloride such as: weakness, confusion, excessive sweating, weight loss, abdominal pain, salt cravings, diarrhea, constipation, dizziness or light-headedness.
Advise breastfeeding mothers who were exposed to dexmedetomidine hydrochloride to monitor breastfed neonates for irritability [see Use in Specific Populations (8.2)].

Manufactured for:

Mylan Institutional LLC

Morgantown, WV 26505 U.S.A.

Manufactured by:

Mylan Laboratories Limited

Bangalore, India

DECEMBER 2022

Package/Label Display Panel

NDC 67457-924-50

Dexmedetomidine HCl in 0.9% Sodium Chloride Injection

200 mcg*/50 mL

(4 mcg*/mL)

For Intravenous Infusion

Discard Unused Portion.

Mylan

Rx only

20 Units x 50 mL Single-Dose Bottles

Carton Label -- 50 mL
(click image for full-size original)

Package/Label Display Panel

NDC 67457-925-10

Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection

400 mcg/100 mL

4 mcg/mL

For Intravenous Infusion

Discard Unused Portion.

Mylan

Rx only

10 Units x 100 mL Single-Dose Bottles

Carton Label -- 100 mL
(click image for full-size original)
DEXMEDETOMIDINE HYDROCHLORIDE
dexmedetomidine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67457-924
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXMEDETOMIDINE HYDROCHLORIDE (DEXMEDETOMIDINE) DEXMEDETOMIDINE 200 ug in 50 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 450 mg in 50 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67457-924-50 20 BOTTLE in 1 CARTON contains a BOTTLE (67457-924-00)
1 NDC:67457-924-00 50 mL in 1 BOTTLE This package is contained within the CARTON (67457-924-50)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212571 11/13/2020
DEXMEDETOMIDINE HYDROCHLORIDE
dexmedetomidine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67457-925
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXMEDETOMIDINE HYDROCHLORIDE (DEXMEDETOMIDINE) DEXMEDETOMIDINE 400 ug in 100 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 900 mg in 100 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67457-925-10 10 BOTTLE in 1 CARTON contains a BOTTLE (67457-925-00)
1 NDC:67457-925-00 100 mL in 1 BOTTLE This package is contained within the CARTON (67457-925-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212571 11/13/2020
Labeler — Mylan Institutional LLC (790384502)

Revised: 12/2022 Mylan Institutional LLC

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