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NDC 71288-0803-21 Mycophenolate Mofetil 500 mg/20mL Details
Mycophenolate Mofetil 500 mg/20mL
Mycophenolate Mofetil is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Meitheal Pharmaceuticals Inc.. The primary component is MYCOPHENOLATE MOFETIL.
MedlinePlus Drug Summary
Mycophenolate injection is used with other medications to help prevent transplant organ rejection (attack of the transplanted organ by the immune system of the person receiving the organ) in adults and children 3 months of age and older who have received kidney, heart, or liver transplants and who cannot take oral medication. Mycophenolate is in a class of medications called immunosuppressive agents. It works by weakening the body's immune system so it will not attack and reject the transplanted organ.
Related Packages: 71288-0803-21Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Mycophenolate Injection
Product Information
| NDC | 71288-0803 |
|---|---|
| Product ID | 71288-803_7779ad7f-a903-46b7-ad32-b25ce2c8518c |
| Associated GPIs | 99403030202120 |
| GCN Sequence Number | 040376 |
| GCN Sequence Number Description | mycophenolate mofetil HCl VIAL 500 MG INTRAVEN |
| HIC3 | Z2E |
| HIC3 Description | IMMUNOSUPPRESSIVES |
| GCN | 47569 |
| HICL Sequence Number | 018603 |
| HICL Sequence Number Description | MYCOPHENOLATE MOFETIL HCL |
| Brand/Generic | Generic |
| Proprietary Name | Mycophenolate Mofetil |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Mycophenolate Mofetil |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 500 |
| Active Ingredient Units | mg/20mL |
| Substance Name | MYCOPHENOLATE MOFETIL |
| Labeler Name | Meitheal Pharmaceuticals Inc. |
| Pharmaceutical Class | Antimetabolite Immunosuppressant [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA212130 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 71288-0803-21 (71288080321)
| NDC Package Code | 71288-803-21 |
|---|---|
| Billing NDC | 71288080321 |
| Package | 4 VIAL, SINGLE-DOSE in 1 CARTON (71288-803-21) / 20 mL in 1 VIAL, SINGLE-DOSE (71288-803-20) |
| Marketing Start Date | 2021-01-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |