Dexmedetomidine Hydrochloride in Sodium Chloride (Page 7 of 7)

16. HOW SUPPLIED/STORAGE AND HANDLING

Dexmedetomidine HCl in 0.9% sodium chloride injection

Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is clear and colorless, and available as 80 mcg/20 mL (4 mcg/mL), 200 mcg/50 mL (4 mcg/mL) and 400 mcg/100 mL (4 mcg/mL) in 20 mL, 50 mL, and 100 mL clear glass bottles. The strength is based on the dexmedetomidine base. Containers are intended for single-dose only. Discard unused portion.

NDC Container Size
68094-047-10 Vial 10 × 20 mL
68094-147-10 Bottle 20 × 50 mL
68094-247-10 Bottle 10 × 100 mL

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

17. PATIENT COUNSELING INFORMATION

Dexmedetomidine HCl in 0.9% sodium chloride injection 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 HCl in 0.9% sodium chloride injection and as clinically appropriate after discontinuation.

  • When dexmedetomidine HCl in 0.9% sodium chloride injection 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 HCl in 0.9% sodium chloride injection 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 HCl in 0.9% sodium chloride injection to monitor breastfed neonates for irritability [see Use in Specific Populations (8.2)].

Manufactured for:

Precision Dose, Inc.
South Beloit, IL 61080

Rev. 04/2023

PRINCIPAL DISPLAY PANEL — 20 mL Vial Label

20 mL
Rx only
NDC 68094-047-01

Single-dose vial. Discard unused portion.

Dexmedetomidine HCl in
0.9% Sodium Chloride Injection

80 mcg/20 mL (4 mcg/mL)*

For Intravenous Infusion

PrecisionDose

LOTEXP. DATE

PRINCIPAL DISPLAY PANEL -- 20 mL Vial Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 50 mL Bottle Label

50 mL
Rx only
NDC 68094-147-01

Single-dose bottle. Discard unused portion.

Dexmedetomidine HCl in 0.9% Sodium Chloride Injection

200 mcg / 50 mL (4 mcg/mL)*

For Intravenous Infusion

64000063 F.112

LOTEXP. DATE

PRINCIPAL DISPLAY PANEL -- 50 mL Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 100 mL Bottle Label

100 mL
Rx only
NDC 68094-247-01

Single-dose bottle. Discard unused portion.

Dexmedetomidine HCl in 0.9%
Sodium Chloride Injection

400 mcg / 100 mL (4 mcg/mL)*

For Intravenous Infusion

64000064 F.113

LOTEXP. DATE

PRINCIPAL DISPLAY PANEL -- 100 mL Bottle Label
(click image for full-size original)
DEXMEDETOMIDINE HYDROCHLORIDE IN SODIUM CHLORIDE dexmedetomidine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68094-047
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
Inactive Ingredients
Ingredient Name Strength
sodium chloride 9 mg in 1 mL
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68094-047-10 10 VIAL in 1 CARTON contains a VIAL (68094-047-01)
1 NDC:68094-047-01 20 mL in 1 VIAL This package is contained within the CARTON (68094-047-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212857 11/23/2020
DEXMEDETOMIDINE HYDROCHLORIDE IN SODIUM CHLORIDE dexmedetomidine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68094-147
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
Inactive Ingredients
Ingredient Name Strength
sodium chloride 9 mg in 1 mL
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68094-147-20 20 BOTTLE in 1 CARTON contains a BOTTLE (68094-147-01)
1 NDC:68094-147-01 50 mL in 1 BOTTLE This package is contained within the CARTON (68094-147-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212857 11/23/2020
DEXMEDETOMIDINE HYDROCHLORIDE IN SODIUM CHLORIDE dexmedetomidine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68094-247
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
Inactive Ingredients
Ingredient Name Strength
sodium chloride 9 mg in 1 mL
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68094-247-10 10 BOTTLE in 1 CARTON contains a BOTTLE (68094-247-01)
1 NDC:68094-247-01 100 mL in 1 BOTTLE This package is contained within the CARTON (68094-247-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212857 11/23/2020
Labeler — Precision Dose, Inc. (035886746)
Establishment
Name Address ID/FEI Operations
Corden Pharma SPA 338725627 MANUFACTURE (68094-047), MANUFACTURE (68094-147), MANUFACTURE (68094-247), ANALYSIS (68094-047), ANALYSIS (68094-147), ANALYSIS (68094-247), PACK (68094-047), PACK (68094-147), PACK (68094-247), LABEL (68094-047), LABEL (68094-147), LABEL (68094-247)

Revised: 12/2023 Precision Dose, Inc.

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