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NDC 00078-0386-66 Myfortic 360 mg/1 Details
Myfortic 360 mg/1
Myfortic is a ORAL TABLET, DELAYED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is MYCOPHENOLATE SODIUM.
MedlinePlus Drug Summary
Mycophenolate (CellCept) 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. Mycophenolate (Myfortic) is used with other medications to help prevent the body from rejecting kidney transplants in adults and children 5 years of age and older. 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: 00078-0386-66Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Mycophenolate
Product Information
| NDC | 00078-0386 |
|---|---|
| Product ID | 0078-0386_c42ba1b1-8510-46ff-8de5-e5aee86faaaf |
| Associated GPIs | 99403030300630 |
| GCN Sequence Number | 052120 |
| GCN Sequence Number Description | mycophenolate sodium TABLET DR 360 MG ORAL |
| HIC3 | Z2E |
| HIC3 Description | IMMUNOSUPPRESSIVES |
| GCN | 19647 |
| HICL Sequence Number | 025201 |
| HICL Sequence Number Description | MYCOPHENOLATE SODIUM |
| Brand/Generic | Brand |
| Proprietary Name | Myfortic |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | mycophenolic acid |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, DELAYED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 360 |
| Active Ingredient Units | mg/1 |
| Substance Name | MYCOPHENOLATE SODIUM |
| Labeler Name | Novartis Pharmaceuticals Corporation |
| Pharmaceutical Class | Antimetabolite Immunosuppressant [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA050791 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00078-0386-66 (00078038666)
| NDC Package Code | 0078-0386-66 |
|---|---|
| Billing NDC | 00078038666 |
| Package | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (0078-0386-66) |
| Marketing Start Date | 2004-02-27 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 11.1856 |
| Pricing Unit | EA |
| Effective Date | 2021-02-17 |
| NDC Description | MYFORTIC 360 MG TABLET |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 4 |
| Classification for Rate Setting | B |
| As of Date | 2022-02-16 |