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NDC 55150-0376-01 Decitabine 50 mg/26mL Details
Decitabine 50 mg/26mL
Decitabine is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Eugia US LLC. The primary component is DECITABINE.
MedlinePlus Drug Summary
Decitabine is used to treat myelodysplastic syndrome (a group of conditions in which the bone marrow produces blood cells that are misshapen and does not produce enough healthy blood cells). Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow.
Related Packages: 55150-0376-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Decitabine Injection
Product Information
| NDC | 55150-0376 |
|---|---|
| Product ID | 55150-376_2c794637-f383-49c6-9f3d-6bcc25e79e66 |
| Associated GPIs | 21300015002120 |
| GCN Sequence Number | 060839 |
| GCN Sequence Number Description | decitabine VIAL 50 MG INTRAVEN |
| HIC3 | V1B |
| HIC3 Description | ANTINEOPLASTIC - ANTIMETABOLITES |
| GCN | 27027 |
| HICL Sequence Number | 033712 |
| HICL Sequence Number Description | DECITABINE |
| Brand/Generic | Generic |
| Proprietary Name | Decitabine |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Decitabine |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/26mL |
| Substance Name | DECITABINE |
| Labeler Name | Eugia US LLC |
| Pharmaceutical Class | Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA214569 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 55150-0376-01 (55150037601)
| NDC Package Code | 55150-376-01 |
|---|---|
| Billing NDC | 55150037601 |
| Package | 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-376-01) / 26 mL in 1 VIAL, SINGLE-DOSE |
| Marketing Start Date | 2021-09-20 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |