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 ID54436-010_710aac87-b226-446c-97e0-a20e1e55e2b0
NDC54436-010
Product TypeHuman Prescription Drug
Proprietary NameOtrexup
Generic NameMethotrexate
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2013-10-11
Marketing CategoryNDA / NDA
Application NumberNDA204824
Labeler NameAntares Pharma, Inc.
Substance NameMETHOTREXATE
Active Ingredient Strength10 mg/.4mL
Pharm ClassesFolate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 54436-010-01

1 SYRINGE in 1 CARTON (54436-010-01) > .4 mL in 1 SYRINGE
Marketing Start Date2013-10-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54436-010-02 [54436001002]

Otrexup INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA204824
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2013-10-11

NDC 54436-010-04 [54436001004]

Otrexup INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA204824
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2013-10-11

NDC 54436-010-01 [54436001001]

Otrexup INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA204824
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-10-11

NDC 54436-010-03 [54436001003]

Otrexup INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA204824
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-10-11

Drug Details

Active Ingredients

IngredientStrength
METHOTREXATE10 mg/.4mL

OpenFDA Data

SPL SET ID:9ab8ce16-f7de-41d4-a4c8-1c742621b6d5
Manufacturer
UNII
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"

    NDCBrand NameGeneric Name
    54436-015OtrexupOtrexup
    54436-022OtrexupOtrexup
    54436-012OtrexupOtrexup
    54436-017OtrexupOtrexup
    54436-020OtrexupOtrexup
    54436-025OtrexupOtrexup
    54436-010OtrexupOtrexup
    0143-9367MethotrexateMethotrexate
    0143-9516MethotrexateMethotrexate
    0143-9517MethotrexateMethotrexate
    0143-9518MethotrexateMethotrexate
    0143-9519MethotrexateMethotrexate
    0143-9830MethotrexateMethotrexate
    0378-0014Methotrexatemethotrexate
    0555-0572MethotrexateMethotrexate
    0703-3671MethotrexateMethotrexate
    0703-3675MethotrexateMethotrexate
    0703-3678MethotrexateMethotrexate

    Trademark Results [Otrexup]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    OTREXUP
    OTREXUP
    85802703 4988928 Live/Registered
    Antares Pharma Inc.
    2012-12-14
    OTREXUP
    OTREXUP
    85788191 5161291 Live/Registered
    Antares Pharma Inc.
    2012-11-27

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