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NDC 00469-0687-11 ASTAGRAF XL 5 mg/1 Details
ASTAGRAF XL 5 mg/1
ASTAGRAF XL is a ORAL CAPSULE, COATED, EXTENDED RELEASE 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 (Astagraf XL, Envarsus XR, Prograf) is used along with other medications to prevent rejection (attack of a transplanted organ by the immune system of a person receiving the organ) in people who have received a kidney transplant. Tacrolimus (Prograf) is also used along with other medications to prevent rejection in people who have received a liver, lung, or heart transplant. Tacrolimus 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: 00469-0687-11Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Tacrolimus
Product Information
| NDC | 00469-0687 |
|---|---|
| Product ID | 0469-0687_15be9383-263f-4080-bda4-2ab0bdfbf239 |
| Associated GPIs | 99404080007020 |
| GCN Sequence Number | 062898 |
| GCN Sequence Number Description | tacrolimus CAP ER 24H 5 MG ORAL |
| HIC3 | Z2E |
| HIC3 Description | IMMUNOSUPPRESSIVES |
| GCN | 98664 |
| HICL Sequence Number | 020974 |
| HICL Sequence Number Description | TACROLIMUS |
| Brand/Generic | Brand |
| Proprietary Name | ASTAGRAF XL |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | tacrolimus extended-release capsules |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE, COATED, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/1 |
| 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 | NDA204096 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00469-0687-11 (00469068711)
| NDC Package Code | 0469-0687-11 |
|---|---|
| Billing NDC | 00469068711 |
| Package | 5 BLISTER PACK in 1 CARTON (0469-0687-11) / 10 CAPSULE, COATED, EXTENDED RELEASE in 1 BLISTER PACK |
| Marketing Start Date | 2013-07-19 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |