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NDC 57894-0640-04 Tremfya 100 mg/mL Details
Tremfya 100 mg/mL
Tremfya is a SUBCUTANEOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Janssen Biotech, Inc.. The primary component is GUSELKUMAB.
MedlinePlus Drug Summary
Guselkumab injection is used to treat moderate to severe plaque psoriasis (a skin disease in which red, scaly patches form on some areas of the body) in adults whose psoriasis is too severe to be treated by topical medications alone. It is also used alone or in combination with other medications to treat psoriatic arthritis (a condition that causes joint pain and swelling and scales on the skin) in adults. Guselkumab injection is in a class of medications called monoclonal antibodies. It works by stopping the action of certain cells in the body that cause the symptoms of psoriasis.
Related Packages: 57894-0640-04Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guselkumab Injection
Product Information
| NDC | 57894-0640 |
|---|---|
| Product ID | 57894-640_09bab28f-d731-f2e7-e063-6294a90a1b79 |
| Associated GPIs | 9025054200E520 9025054200D220 |
| GCN Sequence Number | 077565 |
| GCN Sequence Number Description | guselkumab SYRINGE 100 MG/ML SUBCUT |
| HIC3 | L1A |
| HIC3 Description | ANTIPSORIATIC AGENTS,SYSTEMIC |
| GCN | 43612 |
| HICL Sequence Number | 044418 |
| HICL Sequence Number Description | GUSELKUMAB |
| Brand/Generic | Brand |
| Proprietary Name | Tremfya |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Guselkumab |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | SUBCUTANEOUS |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | mg/mL |
| Substance Name | GUSELKUMAB |
| Labeler Name | Janssen Biotech, Inc. |
| Pharmaceutical Class | Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA761061 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 57894-0640-04 (57894064004)
| NDC Package Code | 57894-640-04 |
|---|---|
| Billing NDC | 57894064004 |
| Package | 1 SYRINGE in 1 CARTON (57894-640-04) / 1 mL in 1 SYRINGE |
| Marketing Start Date | 2017-07-13 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |