1. Home
  2. Labeler Index
  3. Medunik
  4. 71770-105
  5. NDC Package Code: 71770-105-60 Siklos

NDC Package 71770-105-60 Siklos

Hydroxyurea Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
71770-105-60
Package Description:
1 BOTTLE in 1 CARTON / 60 TABLET, FILM COATED in 1 BOTTLE
Product Code:
71770-105
Proprietary Name:
Siklos
Non-Proprietary Name:
Hydroxyurea
Substance Name:
Hydroxyurea
Usage Information:
This medication is used by people with sickle cell anemia to reduce the number of painful crises caused by the disease and to reduce the need for blood transfusions. Some brands are also used to treat certain types of cancer (such as chronic myelogenous leukemia, squamous cell carcinomas).
11-Digit NDC Billing Format:
71770010560
NDC to RxNorm Crosswalk:
  • RxCUI: 1999308 - hydroxyurea 100 MG Oral Tablet
  • RxCUI: 1999314 - Siklos 100 MG Oral Tablet
  • RxCUI: 1999314 - hydroxyurea 100 MG Oral Tablet [Siklos]
  • RxCUI: 1999316 - Siklos 1000 MG Oral Tablet
  • RxCUI: 1999316 - hydroxyurea 1000 MG Oral Tablet [Siklos]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Medunik
    Dosage Form:
    Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • HYDROXYUREA 100 mg/1
    • Pharmacologic Class(es):
  • Antimetabolite - [EPC] (Established Pharmacologic Class)
  • Urea - [CS]
    • Sample Package:
    No
    FDA Application Number:
    NDA208843
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    10-15-2020
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 71770-105-60?

    The NDC Packaged Code 71770-105-60 is assigned to a package of 1 bottle in 1 carton / 60 tablet, film coated in 1 bottle of Siklos, a human prescription drug labeled by Medunik. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 71770-105 included in the NDC Directory?

    Yes, Siklos with product code 71770-105 is active and included in the NDC Directory. The product was first marketed by Medunik on October 15, 2020 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 71770-105-60?

    The 11-digit format is 71770010560. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-271770-105-605-4-271770-0105-60