Search by Drug Name or NDC
NDC 68382-0352-77 sirolimus 2 mg/1 Details
sirolimus 2 mg/1
sirolimus is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Zydus Pharmaceuticals USA Inc.. The primary component is SIROLIMUS.
MedlinePlus Drug Summary
Sirolimus is used in combination with other medications to prevent rejection of kidney transplants. Sirolimus is in a class of medications called immunosuppressants. It works by suppressing the body's immune system.
Related Packages: 68382-0352-77Last Updated: 04/28/2024
MedLinePlus Full Drug Details: Sirolimus
Product Information
| NDC | 68382-0352 |
|---|---|
| Product ID | 68382-352_f54f3f24-5d0f-44a1-a4ca-03950954826f |
| Associated GPIs | |
| GCN Sequence Number | 051878 |
| GCN Sequence Number Description | sirolimus TABLET 2 MG ORAL |
| HIC3 | Z2E |
| HIC3 Description | IMMUNOSUPPRESSIVES |
| GCN | 19299 |
| HICL Sequence Number | 020519 |
| HICL Sequence Number Description | SIROLIMUS |
| Brand/Generic | Generic |
| Proprietary Name | sirolimus |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | sirolimus |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 2 |
| Active Ingredient Units | mg/1 |
| Substance Name | SIROLIMUS |
| Labeler Name | Zydus Pharmaceuticals USA Inc. |
| Pharmaceutical Class | Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA201676 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 68382-0352-77 (68382035277)
| NDC Package Code | 68382-352-77 |
|---|---|
| Billing NDC | 68382035277 |
| Package | 10 BLISTER PACK in 1 CARTON (68382-352-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-352-30) |
| Marketing Start Date | 2023-02-16 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |