METHOTREXATE- methotrexate solution
ThyMoorgan GmbH Pharmazir & Co. K.G

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Methotrexate Injection, USP

Methotrexate 2 mL

Methotrexate Injection, USP 50 mg/2 mL Vial Label

NDC 0143-9519-01 Rx only

50 mg/2 mL

(25 mg/mL)

STERILE ISOTONIC

SOLUTION

2 mL Single Dose Vial

Methotrexate Injection, USP 50 mg/2 mL Carton

NDC 0143-9519-10 Rx only

10 x 2 mL Single-Dose Vials

Methotrexate Injection, USP

50 mg/2 mL

(25 mg/mL)

STERILE ISOTONIC

SOLUTION

Preservative Free

CYTOTOXIC AGENT

Protect from light

Retain in carton until ready to use

Methotrexate 4 mL

Methotrexate Injection, USP 100 mg/4 mL Vial Label

NDC 0143-9518-01 Rx only

Methotrexate Injection, USP

100 mg/4 mL

(25 mg/mL)

STERILE ISOTONIC

SOLUTION

4 mL Single Dose Vial

Methotrexate Injection, USP 100 mg/4 mL Carton

NDC 0143-9518-01 Rx only

1 x 4 mL Single-Dose Vial

Methotrexate Injection, USP

100 mg/4 mL

(25 mg/mL)

Preservative-Free

CYTOTOXIC AGENT

STERILE ISOTONIC

SOLUTION

Protect from light

Retain in carton until ready to use

Methotrexate 8 mL

Methotrexate Injection, USP 200 mg/8 mL Vial Label

NDC 0143-9517-01 Rx only

Methotrexate Injection, USP

200 mg/8 mL

(25 mg/mL)

STERILE ISOTONIC

SOLUTION

8 mL Single Dose Vial

Methotrexate Injection, USP 200 mg/8 mL Carton

NDC 0143-9517-01 Rx only

1 x 8 mL Single Dose Vial

Methotrexate Injection, USP

200 mg/8 mL

(25 mg/mL)

Preservative-Free

CYTOTOXIC AGENT

STERILE ISOTONIC

SOLUTION

Protect from light

Retain in carton until ready to use

Methotrexate 10 mL

Methotrexate Injection, USP 250 mg/10 mL Vial label

NDC 0143-9516-01 Rx only

Methotrexate Injection, USP

250 mg/10 mL

(25 mg/mL)

STERILE ISOTONIC

SOLUTION

10 mL Single Dose Vial

Methotrexate Injection, USP 250 mg/10 mL Carton

NDC 0143-9516-01 Rx only

1 x 10 mL Single Dose Vial

Methotrexate Injection, USP

250 mg/10 mL

(25 mg/mL)

Preservative-Free

CYTOTOXIC AGENT

STERILE ISOTONIC

SOLUTION

Protect from light

Retain in carton until ready to use

METHOTREXATE
methotrexate solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:42605-034
Route of Administration	INTRA-ARTERIAL, INTRAMUSCULAR, INTRATHECAL, INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METHOTREXATE (UNII: YL5FZ2Y5U1) (METHOTREXATE - UNII:YL5FZ2Y5U1)	METHOTREXATE	25 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:42605-034-10	10 in 1 CARTON	10/10/2017
1		2 mL in 1 VIAL; 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	ANDA089340	10/10/2017

METHOTREXATE
methotrexate solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:42605-035
Route of Administration	INTRA-ARTERIAL, INTRAMUSCULAR, INTRATHECAL, INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METHOTREXATE (UNII: YL5FZ2Y5U1) (METHOTREXATE - UNII:YL5FZ2Y5U1)	METHOTREXATE	25 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:42605-035-01	1 in 1 BOX	01/05/2018
1		4 mL in 1 VIAL; 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	ANDA089341	01/05/2018

METHOTREXATE
methotrexate solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:42605-036
Route of Administration	INTRA-ARTERIAL, INTRAMUSCULAR, INTRATHECAL, INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METHOTREXATE (UNII: YL5FZ2Y5U1) (METHOTREXATE - UNII:YL5FZ2Y5U1)	METHOTREXATE	25 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:42605-036-01	1 in 1 BOX	01/05/2018
1		8 mL in 1 VIAL; 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	ANDA089342	01/05/2018

METHOTREXATE
methotrexate solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:42605-037
Route of Administration	INTRA-ARTERIAL, INTRAMUSCULAR, INTRATHECAL, INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METHOTREXATE (UNII: YL5FZ2Y5U1) (METHOTREXATE - UNII:YL5FZ2Y5U1)	METHOTREXATE	25 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:42605-037-01	1 in 1 BOX	01/05/2018
1		10 mL in 1 VIAL; 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	ANDA089343	01/05/2018

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

Registrant - West-ward Pharmaceuticals Corp (001230762)

Revised: 1/2018

Document Id: 701335ad-bdf1-4257-8ddf-79be2297a1bc

Set id: 765d038a-bd5b-4a5a-9be9-5244add268ff

Version: 2

Effective Time: 20180118

ThyMoorgan GmbH Pharmazir & Co. K.G