DEXMEDETOMIDINE HYDROCHLORIDE: Package Insert and Label Information (Page 4 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

Dexmedetomidine hydrochloride in 0.9% Sodium Chloride Injection Dexmedetomidine hydrochloride in 0.9% Sodium Chloride injection is a clear colorless solution 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 clear single-dose vial, 50 mL and 100 mL clear single-dose bottles, respectively. Containers are intended for single use only.

NDC No. Strength Vial/Bottle Size
71225-126-01 4 mcg/mL 20 mL Single-dose vial
71225-126-04 4 mcg/mL 20 mL Single-dose vial packaged in a carton containing 10 vials
71225-126-02 4 mcg/mL 50 mL Single-dose bottle
71225-126-05 4 mcg/mL 50 mL Single-dose bottle packaged in a carton containing 20 bottles
71225-126-03 4 mcg/mL 100 mL Single-dose bottle
71225-126-06 4 mcg/mL 100 mL Single-dose bottle packaged in a carton containing 10 bottles

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

17 PATIENT COUNSELING INFORMATION

Dexmedetomidine hydrochloride 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 hydrochloride in 0.9% Sodium Chloride injection and as clinically appropriate after discontinuation.

  • When dexmedetomidine hydrochloride 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 hydrochloride in 0.9% Sodium Chloride injection such as: weakness, confusion, excessive sweating, weight loss, abdominal pain, salt cravings, diarrhea, constipation, dizziness or light-headedness.

Manufactured for:

Slayback Pharma LLC,

Princeton, NJ 08540.

Manufactured at:

Corden Pharma S.p.A,

Caponago, Italy.

Revised: 12/2019

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

20 mL VIAL LABEL
NDC 71225-126-01
Single-dose vial. Discard unused portion.
Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection
80 mcg/20 mL
(4 mcg/mL)
For Intravenous Infusion Rx Only

Dexmed 20ml vial Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 20 mL CARTON LABEL
10 x 20 mL Single-Dose vial
NDC 71225-126-04
Single-dose vial. Discard unused portion.
Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection
80 mcg/20 mL
(4 mcg/mL)
For Intravenous Infusion Rx Only

Dexmed 20 mL Carton label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 50 mL BOTTLE LABEL
NDC 71225-126-02
Single-dose bottle. Discard unused portion.
Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection
200 mcg/50 mL
(4 mcg/mL)
For Intravenous Infusion Rx Only

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

PRINCIPAL DISPLAY PANEL — 50 mL CARTON LABEL
20 Units x 50 mL
NDC 71225-126-05
Single-dose bottle. Discard unused portion.
Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection
200 mcg/50 mL
(4 mcg/mL)
For Intravenous Infusion Rx Only

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

PRINCIPAL DISPLAY PANEL — 100 mL BOTTLE LABEL
NDC 71225-126-03
Single-dose bottle. Discard unused portion.
Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection
400 mcg/100 mL
(4 mcg/mL)
For Intravenous Infusion Rx Only

Dexmed 100mL container label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 100 mL CARTON LABEL
10 Units x 100 mL
NDC 71225-126-06
Single-dose bottle. Discard unused portion.
Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection
400 mcg/100 mL
(4 mcg/mL)
For Intravenous Infusion Rx Only

Dexmed 100mL Carton label
(click image for full-size original)
DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71225-126
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
METHIONINE 1 mg in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71225-126-05 20 BOTTLE in 1 CARTON contains a BOTTLE (71225-126-02)
1 NDC:71225-126-02 50 mL in 1 BOTTLE This package is contained within the CARTON (71225-126-05)
2 NDC:71225-126-06 10 BOTTLE in 1 CARTON contains a BOTTLE (71225-126-03)
2 NDC:71225-126-03 100 mL in 1 BOTTLE This package is contained within the CARTON (71225-126-06)
3 NDC:71225-126-04 10 VIAL in 1 CARTON contains a VIAL (71225-126-01)
3 NDC:71225-126-01 20 mL in 1 VIAL This package is contained within the CARTON (71225-126-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212791 12/06/2019
Labeler — Slayback Pharma LLC (967770848)
Establishment
Name Address ID/FEI Operations
Corden Pharma SpA 338725627 ANALYSIS (71225-126), LABEL (71225-126), MANUFACTURE (71225-126), PACK (71225-126)

Revised: 05/2020 Slayback Pharma LLC

Page 4 of 4 1 2 3 4

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2020. All Rights Reserved.