IDARUBICIN HYDROCHLORIDE- idarubicin hydrochloride injection, solution
ThyMoorgan GmbH Pharmazir & Co. K.G

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Idarubicin Hydrochloride Injection, USP

Principal Display Panel - 5 mL

NDC 0143-9217-01 Rx only

5 mg/5 mL

(1 mg/mL)

Sterile, Isotonic Solution

FOR IV USE ONLY

Idarubicin Hydrochloride Injection 5 mL vial label

NDC 0143-9217-01 Rx only

5 mL Single Dose Vial

Idarubicin Hydrochloride Injection, USP

5 mg/5 mL

(1 mg/mL)

Sterile, Isotonic Solution

FOR INTRAVENOUS USE ONLY

Idarubicin Hydrochloride Injection 5 mL Carton

Principal Display Panel - 10 mL

NDC 0143-9218-01 Rx only

Idarubicin Hydrochloride Injection, USP

10 mg/10 mL

(1 mg/mL)

Sterile, Isotonic Solution

FOR INTRAVENOUS USE ONLY

Idarubicin Hydrochloride Injection 10 mL vial label

NDC 0143-9218-01 Rx only

10 mL Single Dose Vial

Idarubicin Hydrochloride Injection, USP

10 mg/10 mL

(1 mg/mL)

Sterile, Isotonic Solution

FOR INTRAVENOUS USE ONLY

Idarubicin Hydrochloride Injection 10 mL Carton

Principal Display Panel - 20 mL

NDC 0143-9219-01 Rx only

Idarubicin Hydrochloride Injection, USP

20 mg/20 mL

(1 mg/mL)

Sterile, Isotonic Solution

FOR INTRAVENOUS USE ONLY

Idarubicin Hydrochloride Injection 20 mL vial label

NDC 0143-9219-01 Rx only

20 mL Single Dose Vial

Idarubicin Hydrochloride Injection, USP

20 mg/20 mL

(1 mg/mL)

Sterile, Isotonic Solution

FOR INTRAVENOUS USE ONLY

Idarubicin Hydrochloride Injection 20 mL Carton

Principal Display Panel - 5 mL Novaplus

Idarubicin Hydrochloride Injection, USP Carton 5 mg/5 mL

NDC 0143-9306-01 Rx only

5 mL Single Dose Vial

Idarubicin Hydrochloride Injection, USP

5 mg/5 mL

(1 mg/mL)

Sterile, Isotonic Solution

FOR INTRAVENOUS USE ONLY

novaplus

Idarubicin Hydrochloride Injection, USP Vial Label 5 mg/5 mL

NDC 0143-9306-01 Rx only

Idarubicin Hydrochloride Injection, USP

5 mg/5 mL

(1 mg/mL)

Sterile, Isotonic Solution

FOR IV USE ONLY

novaplus

Principal Display Panel - 10 mL Novaplus

Idarubicin Hydrochloride Injection, USP Vial Label 10 mg/10 mL

NDC 0143-9307-01 Rx only

Idarubicin Hydrochloride Injection, USP

10 mg/10 mL

(1 mg/mL)

Sterile, Isotonic Solution

FOR INTRAVENOUS USE ONLY

novaplus

Idarubicin Hydrochloride Injection, USP Carton 10 mg/10 mL

NDC 0143-9307-01 Rx only

10 mL Single Dose Vial

Idarubicin Hydrochloride Injection, USP

10 mg/10 mL

(1 mg/mL)

Sterile, Isotonic Solution

FOR INTRAVENOUS USE ONLY

novaplus

Principal Display Panel - 20 mL Novaplus

Idarubicin Hydrochloride Injection, USP Vial Label 20 mg/20 mL

NDC 0143-9308-01 Rx only

Idarubicin Hydrochloride Injection, USP

20 mg/20 mL

(1 mg/mL)

Sterile, Isotonic Solution

FOR INTRAVENOUS USE ONLY

novaplus

Idarubicin Hydrochloride Injection, USP Carton 20 mg/20 mL

NDC 0143-9308-01 Rx only

20 mL Single Dose Vial

Idarubicin Hydrochloride Injection, USP

20 mg/20 mL

(1 mg/mL)

Sterile, Isotonic Solution

FOR INTRAVENOUS USE ONLY

novaplus

IDARUBICIN HYDROCHLORIDE
idarubicin hydrochloride injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:42605-021
Route of Administration	INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
IDARUBICIN HYDROCHLORIDE (UNII: 5VV3MDU5IE) (IDARUBICIN - UNII:ZRP63D75JW)	IDARUBICIN HYDROCHLORIDE	1 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)	25 mg in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:42605-021-01	1 in 1 BOX	01/30/2017
1		5 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT	ANDA065275	01/30/2017

IDARUBICIN HYDROCHLORIDE
idarubicin hydrochloride injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:42605-022
Route of Administration	INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
IDARUBICIN HYDROCHLORIDE (UNII: 5VV3MDU5IE) (IDARUBICIN - UNII:ZRP63D75JW)	IDARUBICIN HYDROCHLORIDE	1 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)	25 mg in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:42605-022-01	1 in 1 BOX	01/30/2017
1		10 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT	ANDA065275	01/30/2017

IDARUBICIN HYDROCHLORIDE
idarubicin hydrochloride injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:42605-023
Route of Administration	INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
IDARUBICIN HYDROCHLORIDE (UNII: 5VV3MDU5IE) (IDARUBICIN - UNII:ZRP63D75JW)	IDARUBICIN HYDROCHLORIDE	1 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)	25 mg in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:42605-023-01	1 in 1 BOX	01/30/2017
1		20 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT	ANDA065275	01/30/2017

Labeler - ThyMoorgan GmbH Pharmazir & Co. K.G (319029989)

Registrant - West-ward Pharmaceuticals Corp (001230762)

Revised: 1/2018

Document Id: 7d8b1b53-70d9-47d1-9e67-40eeaea24197

Set id: ce06e905-d20a-414e-a147-39c59cf57234

Version: 3

Effective Time: 20180112

ThyMoorgan GmbH Pharmazir & Co. K.G