NDC 54436-010

Otrexup

Methotrexate

Otrexup is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Antares Pharma, Inc.. The primary component is Methotrexate.

• Product ID: 54436-010_710aac87-b226-446c-97e0-a20e1e55e2b0
• NDC: 54436-010
• Product Type: Human Prescription Drug
• Proprietary Name: Otrexup
• Generic Name: Methotrexate
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2013-10-11
• Marketing Category: NDA / NDA
• Application Number: NDA204824
• Labeler Name: Antares Pharma, Inc.
• Substance Name: METHOTREXATE
• Active Ingredient Strength: 10 mg/.4mL
• Pharm Classes: Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 54436-010-01

1 SYRINGE in 1 CARTON (54436-010-01) > .4 mL in 1 SYRINGE

• Marketing Start Date: 2013-10-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 54436-010-02 [54436001002]

Otrexup INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA204824
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2013-10-11

NDC 54436-010-04 [54436001004]

Otrexup INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA204824
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2013-10-11

NDC 54436-010-01 [54436001001]

Otrexup INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA204824
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-10-11

NDC 54436-010-03 [54436001003]

Otrexup INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA204824
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-10-11

Drug Details

Active Ingredients

Ingredient	Strength
METHOTREXATE	10 mg/.4mL

OpenFDA Data

• SPL SET ID: 9ab8ce16-f7de-41d4-a4c8-1c742621b6d5
• Manufacturer:
  • Antares Pharma, Inc.
• UNII:
  • YL5FZ2Y5U1
• RxNorm Concept Unique ID - RxCUI:
  • 1747181
  • 1747194
  • 1747187
  • 1747185
  • 1747179
  • 1441422
  • 1594757
  • 1747192
  • 1441424
  • 1441413
  • 1441407
  • 1441411
  • 1441416
  • 1441402
  • 1594759
  • 1441418

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
54436-015	Otrexup	Otrexup
54436-022	Otrexup	Otrexup
54436-012	Otrexup	Otrexup
54436-017	Otrexup	Otrexup
54436-020	Otrexup	Otrexup
54436-025	Otrexup	Otrexup
54436-010	Otrexup	Otrexup
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