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NDC 61269-0835-10 HYDREA 500 mg/1 Details
HYDREA 500 mg/1
HYDREA is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by H2-Pharma LLC. The primary component is HYDROXYUREA.
MedlinePlus Drug Summary
Hydroxyurea (Hydrea) is used alone or with other medications or radiation therapy to treat a certain type of chronic myelogenous leukemia (CML; a type of cancer of the white blood cells) and certain types of head and neck cancer (including cancer of the mouth, cheek, tongue, throat, tonsils, and sinuses). Hydroxyurea (Droxia, Siklos) is used to reduce the frequency of painful crises and reduce the need for blood transfusions in adults and children 2 years of age and older with sickle cell anemia (an inherited blood disorder in which the red blood cells are abnormally shaped [shaped like a sickle] and cannot bring enough oxygen to all parts of the body). Hydroxyurea is in a class of medications called antimetabolites. Hydroxyurea treats cancer by slowing or stopping the growth of cancer cells in your body. Hydroxyurea treats sickle cell anemia by helping to prevent formation of sickle-shaped red blood cells.
Related Packages: 61269-0835-10Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Hydroxyurea
Product Information
| NDC | 61269-0835 |
|---|---|
| Product ID | 61269-835_18c105ec-bcb3-4506-a91f-f70675f234f3 |
| Associated GPIs | |
| GCN Sequence Number | 008775 |
| GCN Sequence Number Description | hydroxyurea CAPSULE 500 MG ORAL |
| HIC3 | V1A |
| HIC3 Description | ANTINEOPLASTIC - ALKYLATING AGENTS |
| GCN | 38400 |
| HICL Sequence Number | 003897 |
| HICL Sequence Number Description | HYDROXYUREA |
| Brand/Generic | Brand |
| Proprietary Name | HYDREA |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | HYDROXYUREA |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 500 |
| Active Ingredient Units | mg/1 |
| Substance Name | HYDROXYUREA |
| Labeler Name | H2-Pharma LLC |
| Pharmaceutical Class | Antimetabolite [EPC], Urea [CS] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA016295 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 61269-0835-10 (61269083510)
| NDC Package Code | 61269-835-10 |
|---|---|
| Billing NDC | 61269083510 |
| Package | 100 CAPSULE in 1 BOTTLE (61269-835-10) |
| Marketing Start Date | 2009-06-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |