NDC Code(s) : 16729-277-30, 16729-277-03, 16729-277-35
Packager : Accord Healthcare, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

MethotrexateMethotrexate INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-277
Route of Administration INTRA-ARTERIAL, INTRAMUSCULAR, INTRATHECAL, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHOTREXATE(UNII: YL5FZ2Y5U1)
(METHOTREXATE - UNII:YL5FZ2Y5U1) 		METHOTREXATE25 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:16729-277-301 in 1 CARTON 03/07/2014
12 mL in 1 VIAL Type 0: Not a Combination Product
2NDC:16729-277-031 in 1 CARTON 03/07/2014
210 mL in 1 VIAL Type 0: Not a Combination Product
3NDC:16729-277-351 in 1 CARTON 03/07/2014
340 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040716 03/07/2014

LABELER - Accord Healthcare, Inc.(604222237)

Establishment
Name Address ID/FEI Business Operations
Intas Pharmaceuticals Limited 725927649 manufacture(16729-277), analysis(16729-277)

Establishment
Name Address ID/FEI Business Operations
Intas Pharmaceuticals Limited 915837971 manufacture(16729-277), analysis(16729-277)

PRINCIPAL DISPLAY PANEL

NDC 16729- 277-30
2 mL

Methotrexate
Injection, USP

50 mg/2 mL (25 mg/ml)

CAUTION: Cytotoxic Agent

Rx Only Single-Use Vial

VIAL LABEL

PRINCIPAL DISPLAY PANEL

NDC 16729- 277-30
2 mL

Methotrexate
Injection, USP

50 mg/2 mL
(25 mg/mL)

CAUTION: Cytotoxic Agent

Rx Only

Single-Use Vial

CONTAINER LABEL

PRINCIPAL DISPLAY PANEL

NDC 16729- 277-03
10 mL

Methotrexate
Injection, USP

250 mg/10 mL
(25 mg/mL)

CAUTION: Cytotoxic Agent

Rx Only Single-Use Vial

VIAL LABEL

PRINCIPAL DISPLAY PANEL

NDC 16729- 277-03
10 mL

Methotrexate
Injection, USP

250 mg/10 mL
(25 mg/mL)

CAUTION: Cytotoxic Agent

Rx Only

Single-Use Vial

CONTAINER LABEL

PRINCIPAL DISPLAY PANEL

NDC 16729- 277-35
40 mL

Methotrexate
Injection, USP

1 g/40 mL
(25 mg/mL)

CAUTION: Cytotoxic Agent

Rx Only Single-Use Vial

VIAL LABEL

PRINCIPAL DISPLAY PANEL

NDC 16729- 277-35
40 mL

Methotrexate
Injection, USP

1 g/40 mL
(25 mg/mL)

CAUTION: Cytotoxic Agent

Rx Only

Single-Use Vial

CARTON LABEL