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NDC 00469-3016-01 Prograf 5 mg/mL Details
Prograf 5 mg/mL
Prograf is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Astellas Pharma US, Inc.. The primary component is TACROLIMUS.
MedlinePlus Drug Summary
Tacrolimus injection is used along with other medications to prevent rejection (attack of the transplanted organ by the transplant recipient's immune system) in people who have received kidney, liver, or heart transplants. Tacrolimus injection should only be used by people who are unable to take tacrolimus by mouth. Tacrolimus injection is in a class of medications called immunosupressants. It works by decreasing the activity of the immune system to prevent it from attacking the transplanted organ.
Related Packages: 00469-3016-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Tacrolimus Injection
Product Information
| NDC | 00469-3016 |
|---|---|
| Product ID | 0469-3016_32e10bd8-7464-4967-bdc5-1a5ee660bfb3 |
| Associated GPIs | 99404080002010 |
| GCN Sequence Number | 021795 |
| GCN Sequence Number Description | tacrolimus AMPUL 5 MG/ML INTRAVEN |
| HIC3 | Z2E |
| HIC3 Description | IMMUNOSUPPRESSIVES |
| GCN | 28490 |
| HICL Sequence Number | 020974 |
| HICL Sequence Number Description | TACROLIMUS |
| Brand/Generic | Brand |
| Proprietary Name | Prograf |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Tacrolimus |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/mL |
| Substance Name | TACROLIMUS |
| Labeler Name | Astellas Pharma US, Inc. |
| Pharmaceutical Class | Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA050709 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00469-3016-01 (00469301601)
| NDC Package Code | 0469-3016-01 |
|---|---|
| Billing NDC | 00469301601 |
| Package | 10 AMPULE in 1 BOX (0469-3016-01) / 1 mL in 1 AMPULE |
| Marketing Start Date | 1994-04-08 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |