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NDC 00527-5160-82 Mycophenolate Mofetil 200 mg/mL Details
Mycophenolate Mofetil 200 mg/mL
Mycophenolate Mofetil is a ORAL POWDER, FOR SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Lannett Company, Inc.. The primary component is MYCOPHENOLATE MOFETIL.
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: 00527-5160-82Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Mycophenolate
Product Information
| NDC | 00527-5160 |
|---|---|
| Product ID | 0527-5160_cf98576e-03d7-46f1-a7fc-6caef50ac8df |
| Associated GPIs | 99403030101920 |
| GCN Sequence Number | 041845 |
| GCN Sequence Number Description | mycophenolate mofetil SUSP RECON 200 MG/ML ORAL |
| HIC3 | Z2E |
| HIC3 Description | IMMUNOSUPPRESSIVES |
| GCN | 47563 |
| HICL Sequence Number | 010012 |
| HICL Sequence Number Description | MYCOPHENOLATE MOFETIL |
| Brand/Generic | Generic |
| Proprietary Name | Mycophenolate Mofetil |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Mycophenolate Mofetil |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | POWDER, FOR SUSPENSION |
| Route | ORAL |
| Active Ingredient Strength | 200 |
| Active Ingredient Units | mg/mL |
| Substance Name | MYCOPHENOLATE MOFETIL |
| Labeler Name | Lannett Company, Inc. |
| Pharmaceutical Class | Antimetabolite Immunosuppressant [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA214525 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00527-5160-82 (00527516082)
| NDC Package Code | 0527-5160-82 |
|---|---|
| Billing NDC | 00527516082 |
| Package | 1 BOTTLE, PLASTIC in 1 CARTON (0527-5160-82) / 225 mL in 1 BOTTLE, PLASTIC |
| Marketing Start Date | 2021-07-29 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 1.84953 |
| Pricing Unit | ML |
| Effective Date | 2024-02-21 |
| NDC Description | MYCOPHENOLATE 200 MG/ML SUSP |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |