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NDC 71770-0105-60 Siklos 100 mg/1 Details
Siklos 100 mg/1
Siklos is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Medunik. 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: 71770-0105-60Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Hydroxyurea
Product Information
| NDC | 71770-0105 |
|---|---|
| Product ID | 71770-105_9a8e5e5d-2225-4d17-ae10-287fa1ee0616 |
| Associated GPIs | 82803030000320 |
| GCN Sequence Number | 067584 |
| GCN Sequence Number Description | hydroxyurea TABLET 100 MG ORAL |
| HIC3 | N1H |
| HIC3 Description | SICKLE CELL ANEMIA AGENTS |
| GCN | 30164 |
| HICL Sequence Number | 003897 |
| HICL Sequence Number Description | HYDROXYUREA |
| Brand/Generic | Brand |
| Proprietary Name | Siklos |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | hydroxyurea |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | mg/1 |
| Substance Name | HYDROXYUREA |
| Labeler Name | Medunik |
| Pharmaceutical Class | Antimetabolite [EPC], Urea [CS] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA208843 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 71770-0105-60 (71770010560)
| NDC Package Code | 71770-105-60 |
|---|---|
| Billing NDC | 71770010560 |
| Package | 1 BOTTLE in 1 CARTON (71770-105-60) / 60 TABLET, FILM COATED in 1 BOTTLE |
| Marketing Start Date | 2020-10-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |