Sirolimus is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by American Health Packaging. The primary component is Sirolimus.
| Product ID | 68084-956_7b953e74-8cd0-7f3d-e053-2a91aa0a0d7d |
| NDC | 68084-956 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Sirolimus |
| Generic Name | Sirolimus |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2015-03-31 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA201676 |
| Labeler Name | American Health Packaging |
| Substance Name | SIROLIMUS |
| Active Ingredient Strength | 1 mg/1 |
| Pharm Classes | Decreased Immunologic Activity [PE],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA],Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2015-09-30 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA201676 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2015-03-31 |
| Marketing End Date | 2020-04-30 |
| Marketing Category | ANDA |
| Application Number | ANDA201676 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2015-09-30 |
| Marketing End Date | 2020-04-30 |
| Marketing Category | ANDA |
| Application Number | ANDA201676 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2015-11-10 |
| Marketing End Date | 2020-04-30 |
| Marketing Category | ANDA |
| Application Number | ANDA201676 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2015-03-31 |
| Marketing End Date | 2015-11-10 |
| Ingredient | Strength |
|---|---|
| SIROLIMUS | .5 mg/1 |
| SPL SET ID: | f06f88c9-462c-4bf3-aac3-2d155680df6d |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0904-7147 | sirolimus | sirolimus |
| 0904-7248 | Sirolimus | Sirolimus |
| 13668-658 | Sirolimus | Sirolimus |
| 16714-187 | sirolimus | sirolimus |
| 16714-188 | sirolimus | sirolimus |
| 16714-189 | sirolimus | sirolimus |
| 68084-956 | Sirolimus | Sirolimus |
| 68084-915 | Sirolimus | Sirolimus |
| 68382-520 | sirolimus | sirolimus |
| 70954-075 | Sirolimus | Sirolimus |
| 50268-718 | Sirolimus | Sirolimus |
| 55111-654 | Sirolimus | Sirolimus |
| 55111-653 | Sirolimus | Sirolimus |
| 59762-1002 | Sirolimus | Sirolimus |
| 59762-1003 | Sirolimus | Sirolimus |
| 59762-1001 | Sirolimus | Sirolimus |
| 65841-771 | sirolimus | sirolimus |
| 66689-347 | Sirolimus | Sirolimus |
| 59762-1205 | Sirolimus | Sirolimus |
| 69238-1594 | Sirolimus | Sirolimus |
| 60505-6197 | Sirolimus | Sirolimus |
| 68462-682 | sirolimus | sirolimus |
| 68462-684 | sirolimus | sirolimus |
| 68462-683 | sirolimus | sirolimus |
| 0008-1030 | Rapamune | SIROLIMUS |
| 0008-1040 | Rapamune | SIROLIMUS |
| 0008-1041 | Rapamune | SIROLIMUS |
| 0008-1042 | Rapamune | SIROLIMUS |