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NDC 63459-0177-14 SYNRIBO 3.5 mg/mL Details
SYNRIBO 3.5 mg/mL
SYNRIBO is a SUBCUTANEOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Cephalon, LLC. The primary component is OMACETAXINE MEPESUCCINATE.
MedlinePlus Drug Summary
Omacetaxine injection is used to treat adults with chronic myelogenous leukemia (CML; a type of cancer of the white blood cells) who have already been treated with at least two other medications for CML and can no longer benefit from these medications or cannot take these medications due to side effects. Omacetaxine injection is in a class of medications called protein synthesis inhibitors. It works by slowing the growth of cancer cells.
Related Packages: 63459-0177-14Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Omacetaxine Injection
Product Information
| NDC | 63459-0177 |
|---|---|
| Product ID | 63459-177_f68bb131-b4bd-4141-8f45-ff929ac7c225 |
| Associated GPIs | 21700040102120 |
| GCN Sequence Number | 070253 |
| GCN Sequence Number Description | omacetaxine mepesuccinate VIAL 3.5 MG SUBCUT |
| HIC3 | V1F |
| HIC3 Description | ANTINEOPLASTICS,MISCELLANEOUS |
| GCN | 33734 |
| HICL Sequence Number | 024243 |
| HICL Sequence Number Description | OMACETAXINE MEPESUCCINATE |
| Brand/Generic | Brand |
| Proprietary Name | SYNRIBO |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Omacetaxine Mepesuccinate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route | SUBCUTANEOUS |
| Active Ingredient Strength | 3.5 |
| Active Ingredient Units | mg/mL |
| Substance Name | OMACETAXINE MEPESUCCINATE |
| Labeler Name | Cephalon, LLC |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA203585 |
| Listing Certified Through | n/a |
Package
NDC 63459-0177-14 (63459017714)
| NDC Package Code | 63459-177-14 |
|---|---|
| Billing NDC | 63459017714 |
| Package | 1 VIAL, SINGLE-USE in 1 CARTON (63459-177-14) / 1 mL in 1 VIAL, SINGLE-USE |
| Marketing Start Date | 2012-11-19 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |