NDC 0006-4305
Renflexis
Infliximab
Renflexis is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Infliximab.
| Product ID | 0006-4305_00f1b1ba-f1a8-4861-b6bb-d25d842cae6e |
| NDC | 0006-4305 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Renflexis |
| Generic Name | Infliximab |
| Dosage Form | Injection, Powder, Lyophilized, For Solution |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2017-07-01 |
| Marketing Category | BLA / BLA |
| Application Number | BLA761054 |
| Labeler Name | Merck Sharp & Dohme Corp. |
| Substance Name | INFLIXIMAB |
| Active Ingredient Strength | 100 mg/1 |
| Pharm Classes | Tumor Necrosis |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 0006-4305-02
1 VIAL in 1 CARTON (0006-4305-02) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0006-4305-01)
| Marketing Start Date | 2017-07-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0006-4305-02 [00006430502]
Renflexis INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
| Marketing Category | BLA |
| Application Number | BLA761054 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-07-01 |
NDC 0006-4305-01 [00006430501]
Renflexis INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
| Marketing Category | BLA |
| Application Number | BLA761054 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-07-01 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| INFLIXIMAB | 100 mg/1 |
OpenFDA Data
| SPL SET ID: | 3827e1be-f328-45f7-b113-311b57039f8c |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Tumor Necrosis Factor Blocker [EPC]
- Tumor Necrosis Factor Receptor Blocking Activity [MoA]
NDC Crossover Matching brand name "Renflexis" or generic name "Infliximab"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0006-4305 | Renflexis | infliximab |
| 78206-162 | Renflexis | infliximab |
| 57894-160 | INFLIXIMAB | INFLIXIMAB |
| 57894-030 | REMICADE | INFLIXIMAB |
Trademark Results [Renflexis]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RENFLEXIS 87480588 5542207 Live/Registered |
Merck Sharp & Dohme Corp. 2017-06-08 |
 RENFLEXIS 86307793 5311653 Live/Registered |
Merck Sharp & Dohme Corp. 2014-06-12 |
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