otrexup

Generic: methotrexate

Labeler: antares pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name otrexup
Generic Name methotrexate
Labeler antares pharma, inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

methotrexate 12.5 mg/.4mL

Manufacturer
Antares Pharma, Inc.

Identifiers & Regulatory

Product NDC 54436-012
Product ID 54436-012_2d07eb50-d314-a6a0-e063-6394a90ac970
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA204824
Marketing Start 2013-10-11
Marketing End 2027-04-30

Pharmacologic Class

Established (EPC)
folate analog metabolic inhibitor [epc]
Mechanism of Action
folic acid metabolism inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54436012
Hyphenated Format 54436-012

Supplemental Identifiers

RxCUI
1441402 1441407 1441411 1441413 1441416 1441418 1441422 1441424 1594757 1594759 1747179 1747181 1747185 1747187 1747192 1747194
UNII
YL5FZ2Y5U1
NUI
N0000175584 N0000000111

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name otrexup (source: ndc)
Generic Name methotrexate (source: ndc)
Application Number NDA204824 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/.4mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (54436-012-01) / .4 mL in 1 SYRINGE
  • 1 SYRINGE in 1 CARTON (54436-012-03) / .4 mL in 1 SYRINGE
  • 4 SYRINGE in 1 CARTON (54436-012-04) / .4 mL in 1 SYRINGE (54436-012-02)
source: ndc

Packages (3)

54436-012-01 1 SYRINGE in 1 CARTON (54436-012-01) / .4 mL in 1 SYRINGE 54436-012-03 1 SYRINGE in 1 CARTON (54436-012-03) / .4 mL in 1 SYRINGE 54436-012-04 4 SYRINGE in 1 CARTON (54436-012-04) / .4 mL in 1 SYRINGE (54436-012-02)

Ingredients (1)

methotrexate (12.5 mg/.4mL)

Linked Drug Pages (1)

Otrexup ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "2d07eb50-d314-a6a0-e063-6394a90ac970", "openfda": {"nui": ["N0000175584", "N0000000111"], "unii": ["YL5FZ2Y5U1"], "rxcui": ["1441402", "1441407", "1441411", "1441413", "1441416", "1441418", "1441422", "1441424", "1594757", "1594759", "1747179", "1747181", "1747185", "1747187", "1747192", "1747194"], "spl_set_id": ["9ab8ce16-f7de-41d4-a4c8-1c742621b6d5"], "pharm_class_epc": ["Folate Analog Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Folic Acid Metabolism Inhibitors [MoA]"], "manufacturer_name": ["Antares Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (54436-012-01)  / .4 mL in 1 SYRINGE", "package_ndc": "54436-012-01", "marketing_end_date": "20270430", "marketing_start_date": "20160324"}, {"sample": true, "description": "1 SYRINGE in 1 CARTON (54436-012-03)  / .4 mL in 1 SYRINGE", "package_ndc": "54436-012-03", "marketing_end_date": "20270430", "marketing_start_date": "20160324"}, {"sample": false, "description": "4 SYRINGE in 1 CARTON (54436-012-04)  / .4 mL in 1 SYRINGE (54436-012-02)", "package_ndc": "54436-012-04", "marketing_end_date": "20270430", "marketing_start_date": "20160324"}], "brand_name": "Otrexup", "product_id": "54436-012_2d07eb50-d314-a6a0-e063-6394a90ac970", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Folate Analog Metabolic Inhibitor [EPC]", "Folic Acid Metabolism Inhibitors [MoA]"], "product_ndc": "54436-012", "generic_name": "methotrexate", "labeler_name": "Antares Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Otrexup", "active_ingredients": [{"name": "METHOTREXATE", "strength": "12.5 mg/.4mL"}], "application_number": "NDA204824", "marketing_category": "NDA", "marketing_end_date": "20270430", "marketing_start_date": "20131011"}