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 | 54436-020_710aac87-b226-446c-97e0-a20e1e55e2b0 |
NDC | 54436-020 |
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 | 20 mg/.4mL |
Pharm Classes | Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] |
NDC Exclude Flag | N |
Listing Certified Through | 2022-12-31 |
Marketing Start Date | 2013-10-11 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | NDA |
Application Number | NDA204824 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2013-10-11 |
Marketing Category | NDA |
Application Number | NDA204824 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | ML |
Marketing Start Date | 2013-10-11 |
Marketing Category | NDA |
Application Number | NDA204824 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | ML |
Marketing Start Date | 2013-10-11 |
Marketing Category | NDA |
Application Number | NDA204824 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2013-10-11 |
Ingredient | Strength |
---|---|
METHOTREXATE | 20 mg/.4mL |
SPL SET ID: | 9ab8ce16-f7de-41d4-a4c8-1c742621b6d5 |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
OTREXUP 85802703 4988928 Live/Registered |
Antares Pharma Inc. 2012-12-14 |
OTREXUP 85788191 5161291 Live/Registered |
Antares Pharma Inc. 2012-11-27 |