NDC 52652-2001
Xatmep
Methotrexate
Xatmep is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Silvergate Pharmaceuticals, Inc.. The primary component is Methotrexate.
| Product ID | 52652-2001_0587efc3-e149-4fd0-b597-9a8a5212e077 |
| NDC | 52652-2001 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Xatmep |
| Generic Name | Methotrexate |
| Dosage Form | Solution |
| Route of Administration | ORAL |
| Marketing Start Date | 2017-05-01 |
| Marketing Category | NDA / NDA |
| Application Number | NDA208400 |
| Labeler Name | Silvergate Pharmaceuticals, Inc. |
| Substance Name | METHOTREXATE |
| Active Ingredient Strength | 3 mg/mL |
| Pharm Classes | Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 52652-2001-1
120 mL in 1 BOTTLE (52652-2001-1)
| Marketing Start Date | 2017-05-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 52652-2001-6 [52652200106]
Xatmep SOLUTION
| Marketing Category | NDA |
| Application Number | NDA208400 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2018-08-13 |
NDC 52652-2001-1 [52652200101]
Xatmep SOLUTION
| Marketing Category | NDA |
| Application Number | NDA208400 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2017-05-01 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| METHOTREXATE | 2.5 mg/mL |
OpenFDA Data
| SPL SET ID: | aec9984e-34c5-481b-b6bf-9bb5caf1daf8 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Folate Analog Metabolic Inhibitor [EPC]
- Folic Acid Metabolism Inhibitors [MoA]
NDC Crossover Matching brand name "Xatmep" or generic name "Methotrexate"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 52652-2001 | Xatmep | Xatmep |
| 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 |
Trademark Results [Xatmep]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 XATMEP 86934766 5324671 Live/Registered |
Argentum Holdings, LLC 2016-03-09 |
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