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NDC 55111-0527-78 Tacrolimus 5 mg/1 Details
Tacrolimus 5 mg/1
Tacrolimus is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Dr. Reddy's Laboratories Limited. 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: 55111-0527-78Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Tacrolimus
Product Information
| NDC | 55111-0527 |
|---|---|
| Product ID | 55111-527_a0c94acc-3eb7-d790-64b1-0bc8804689de |
| Associated GPIs | 99404080000120 |
| GCN Sequence Number | 021797 |
| GCN Sequence Number Description | tacrolimus CAPSULE 5 MG ORAL |
| HIC3 | Z2E |
| HIC3 Description | IMMUNOSUPPRESSIVES |
| GCN | 28492 |
| HICL Sequence Number | 020974 |
| HICL Sequence Number Description | TACROLIMUS |
| Brand/Generic | Generic |
| Proprietary Name | Tacrolimus |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Tacrolimus |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/1 |
| Substance Name | TACROLIMUS |
| Labeler Name | Dr. Reddy's Laboratories Limited |
| Pharmaceutical Class | Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA090509 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 55111-0527-78 (55111052778)
| NDC Package Code | 55111-527-78 |
|---|---|
| Billing NDC | 55111052778 |
| Package | 10 BLISTER PACK in 1 CARTON (55111-527-78) / 10 CAPSULE in 1 BLISTER PACK (55111-527-79) |
| Marketing Start Date | 2010-05-14 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |