NDC 51285-369

Trexall

Methotrexate

Trexall is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Teva Women's Health, Inc.. The primary component is Methotrexate Sodium.

• Product ID: 51285-369_3049c3a2-587a-447d-b6e6-823f43629bde
• NDC: 51285-369
• Product Type: Human Prescription Drug
• Proprietary Name: Trexall
• Generic Name: Methotrexate
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2001-05-03
• Marketing Category: ANDA / ANDA
• Application Number: ANDA040385
• Labeler Name: Teva Women's Health, Inc.
• Substance Name: METHOTREXATE SODIUM
• Active Ingredient Strength: 15 mg/1
• Pharm Classes: Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 51285-369-01

30 TABLET, FILM COATED in 1 BOTTLE (51285-369-01)

• Marketing Start Date: 2001-05-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 51285-369-01 [51285036901]

Trexall TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA040385
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2001-05-03

Drug Details

Active Ingredients

Ingredient	Strength
METHOTREXATE SODIUM	15 mg/1

OpenFDA Data

• SPL SET ID: e942f8db-510f-44d6-acb5-b822196f5e8c
• Manufacturer:
  • Teva Women's Health, Inc.
• UNII:
  • 3IG1E710ZN
• RxNorm Concept Unique ID - RxCUI:
  • 105586
  • 284592
  • 284593
  • 283510
  • 284594
  • 284595
  • 283511
  • 283671

Pharmacological Class

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

NDC Crossover Matching brand name "Trexall" or generic name "Methotrexate"

NDC	Brand Name	Generic Name
51285-367	Trexall	Trexall
51285-368	Trexall	Trexall
51285-369	Trexall	Trexall
51285-366	Trexall	Trexall
0143-9367	Methotrexate	Methotrexate
0143-9516	Methotrexate	Methotrexate
0143-9517	Methotrexate	Methotrexate
0143-9518	Methotrexate	Methotrexate
0143-9519	Methotrexate	Methotrexate
0143-9830	Methotrexate	Methotrexate
0378-0014	Methotrexate	methotrexate
0555-0572	Methotrexate	Methotrexate
0703-3671	Methotrexate	Methotrexate
0703-3675	Methotrexate	Methotrexate
0703-3678	Methotrexate	Methotrexate