NDC 75840-111

METHOTREXATE SODIUM

Methotrexate Sodium

METHOTREXATE SODIUM is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Genpak Solutions Llc. The primary component is Methotrexate Sodium.

• Product ID: 75840-111_72b163e6-9f58-44a0-bc51-a804036b7da1
• NDC: 75840-111
• Product Type: Human Prescription Drug
• Proprietary Name: METHOTREXATE SODIUM
• Generic Name: Methotrexate Sodium
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2012-10-01
• Marketing Category: NDA / NDA
• Application Number: NDA008085
• Labeler Name: GenPak Solutions LLC
• Substance Name: METHOTREXATE SODIUM
• Active Ingredient Strength: 3 mg/1
• Pharm Classes: Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA]
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 75840-111-00

10 BOX in 1 BLISTER PACK (75840-111-00) > 100 TABLET in 1 BOX (75840-111-01)

• Marketing Start Date: 2012-10-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 75840-111-00 [75840011100]

METHOTREXATE SODIUM TABLET

• Marketing Category: NDA
• Application Number: NDA008085
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-10-01
• Inactivation Date: 2020-01-31

NDC 75840-111-01 [75840011101]

METHOTREXATE SODIUM TABLET

• Marketing Category: NDA
• Application Number: NDA008085
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-10-01

Drug Details

Active Ingredients

Ingredient	Strength
METHOTREXATE SODIUM	2.5 mg/1

OpenFDA Data

• SPL SET ID: b78cd35a-31ae-4404-9b15-eaffaaba42a0
• Manufacturer:
  • GenPak Solutions LLC
• UNII:
  • 3IG1E710ZN
• RxNorm Concept Unique ID - RxCUI:
  • 105585
• UPC Code:
  • 0758400111016

Pharmacological Class

• Folate Analog Metabolic Inhibitor [EPC]
• Folic Acid Metabolism Inhibitors [MoA]

NDC Crossover Matching brand name "METHOTREXATE SODIUM" or generic name "Methotrexate Sodium"

NDC	Brand Name	Generic Name
0054-4550	Methotrexate Sodium	Methotrexate Sodium
0054-8550	Methotrexate Sodium	Methotrexate Sodium
63629-1472	Methotrexate Sodium	Methotrexate Sodium
66758-040	Methotrexate Sodium	Methotrexate Sodium
66758-041	Methotrexate Sodium	Methotrexate Sodium
70518-2711	Methotrexate Sodium	Methotrexate Sodium
75840-111	METHOTREXATE SODIUM	METHOTREXATE SODIUM
21695-111	Methotrexate	Methotrexate sodium
47335-235	Methotrexate	Methotrexate Sodium
50090-3418	Methotrexate	Methotrexate Sodium
63323-122	Methotrexate	METHOTREXATE SODIUM
63323-123	Methotrexate	METHOTREXATE SODIUM
70518-1251	Methotrexate	Methotrexate Sodium