Amiodarone Hydrochloride (Page 7 of 7)

16 HOW SUPPLIED/ STORAGE AND HANDLING

Amiodarone Hydrochloride Injection, USP is supplied as:

150 mg per 3 mL

(50 mg per mL)

NDC: 70518-2792-00

NDC: 70518-2792-01

PACKAGING: 25 in 1 TRAY

PACKAGING: 3 mL in 1 VIAL, SINGLE DOSE TYPE 0

The container closure is not made with natural rubber latex.

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

Protect from light and excessive heat.

Use carton to protect contents from light until used.

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

17 PATIENT COUNSELING INFORMATION

Amiodarone has the potential to cause serious side effects that limit its use to life-threatening and hemodynamically unstable cardiac arrhythmias. Advise female patients to discontinue nursing while being treated with amiodarone, as breast-feeding could expose the nursing infant to a significant dose of the drug. Recommend that patients avoid grapefruit juice, over-the-counter cough medicines (which commonly contain dextromethorphan), and St. John’s Wort. Inform patients that most manufacturers of corneal refractive laser surgery devices contraindicate corneal refractive laser surgery in patients taking amiodarone. Discuss the symptoms of hypo- and hyper-thyroidism, particularly if patients will be transitioned to oral amiodarone.

Repackaged By / Distributed By: RemedyRepack Inc.

625 Kolter Drive, Indiana, PA 15701

(724) 465-8762

DRUG: Amiodarone Hydrochloride

GENERIC: AMIODARONE HYDROCHLORIDE

DOSAGE: INJECTION, SOLUTION

ADMINSTRATION: INTRAVENOUS

NDC: 70518-2792-0

NDC: 70518-2792-1

PACKAGING: 3 mL in 1 VIAL, SINGLE-DOSE

OUTER PACKAGING: 25 in 1 TRAY

ACTIVE INGREDIENT(S):

  • AMIODARONE HYDROCHLORIDE 50mg in 1mL

INACTIVE INGREDIENT(S):

  • WATER
  • POLYSORBATE 80
  • BENZYL ALCOHOL
Remedy_Label
(click image for full-size original)
MM2
(click image for full-size original)
AMIODARONE HYDROCHLORIDE
amiodarone hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-2792(NDC:63323-616)
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMIODARONE HYDROCHLORIDE (AMIODARONE) AMIODARONE HYDROCHLORIDE 50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL 20.2 mg in 1 mL
POLYSORBATE 80 100 mg in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70518-2792-1 25 VIAL, SINGLE-DOSE in 1 TRAY contains a VIAL, SINGLE-DOSE (70518-2792-0)
1 NDC:70518-2792-0 3 mL in 1 VIAL, SINGLE-DOSE This package is contained within the TRAY (70518-2792-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075761 06/19/2020
Labeler — REMEDYREPACK INC. (829572556)

Revised: 03/2024 REMEDYREPACK INC.

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