Amiodarone Hydrochloride (Page 7 of 7)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 900 mg per 18 mL (50 mg / mL) Container Label

Rx only NDC 55150-182-18
Amiodarone
Hydrochloride Injection, USP
900 mg per 18 mL
(50 mg / mL)
For Intravenous Use Only
MUST BE DILUTED
Sterile 18 mL Multiple Dose Vial AUROMEDICS

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 900 mg per 18 mL (50 mg / mL) Container Label
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 900 mg per 18 mL (50 mg / mL) Container-Carton (1 Vial)

Rx only NDC 55150-182-18
Amiodarone
Hydrochloride Injection, USP
900 mg per 18 mL
(50 mg / mL)
For Intravenous Use Only
MUST BE DILUTED
Sterile 18 mL Multiple Dose Vial AUROMEDICS

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 900 mg per 18 mL (50 mg / mL) Container-Carton (1 Vial)
(click image for full-size original)
AMIODARONE HYDROCHLORIDE amiodarone hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55150-180
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMIODARONE HYDROCHLORIDE (AMIODARONE) AMIODARONE HYDROCHLORIDE 150 mg in 3 mL
Inactive Ingredients
Ingredient Name Strength
POLYSORBATE 80
BENZYL ALCOHOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55150-180-03 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
1 3 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (55150-180-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204550 10/25/2017
AMIODARONE HYDROCHLORIDE amiodarone hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55150-181
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMIODARONE HYDROCHLORIDE (AMIODARONE) AMIODARONE HYDROCHLORIDE 450 mg in 9 mL
Inactive Ingredients
Ingredient Name Strength
POLYSORBATE 80
BENZYL ALCOHOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55150-181-09 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
1 9 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (55150-181-09)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204550 10/25/2017
AMIODARONE HYDROCHLORIDE amiodarone hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55150-182
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMIODARONE HYDROCHLORIDE (AMIODARONE) AMIODARONE HYDROCHLORIDE 900 mg in 18 mL
Inactive Ingredients
Ingredient Name Strength
POLYSORBATE 80
BENZYL ALCOHOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55150-182-18 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
1 18 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (55150-182-18)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204550 10/25/2017
Labeler — AuroMedics Pharma LLC (968961354)
Establishment
Name Address ID/FEI Operations
Glenmark Life Sciences Limited 650283737 API MANUFACTURE (55150-180), API MANUFACTURE (55150-181), API MANUFACTURE (55150-182)
Establishment
Name Address ID/FEI Operations
Eugia Pharma Specialities Limited 650498244 ANALYSIS (55150-180), ANALYSIS (55150-181), ANALYSIS (55150-182), MANUFACTURE (55150-180), MANUFACTURE (55150-181), MANUFACTURE (55150-182)

Revised: 12/2021 AuroMedics Pharma LLC

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