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  5. NDC Package Code: 70771-1193-1 Clonidine Hydrochloride

NDC Package 70771-1193-1 Clonidine Hydrochloride

Injection, Solution Epidural - 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:
70771-1193-1
Package Description:
1 VIAL in 1 CARTON / 10 mL in 1 VIAL
Product Code:
70771-1193
Proprietary Name:
Clonidine Hydrochloride
Non-Proprietary Name:
Clonidine Hydrochloride
Substance Name:
Clonidine Hydrochloride
Usage Information:
Clonidine hydrochloride injection is indicated in combination with opiates for the treatment of severe pain in cancer patients that is not adequately relieved by opioid analgesics alone. Epidural clonidine is more likely to be effective in patients with neuropathic pain than somatic or visceral pain (see Clinical Trials). The safety of this drug product has only been established in a highly selected group of cancer patients, and only after an adequate trial of opioid analgesia. Other use is of unproven safety and is not recommended. In a rare patient, the potential benefits may outweigh the known risks (see WARNINGS).
11-Digit NDC Billing Format:
70771119301
NDC to RxNorm Crosswalk:
  • RxCUI: 884221 - cloNIDine HCl 1000 MCG in 10 ML Injection
  • RxCUI: 884221 - 10 ML clonidine hydrochloride 0.1 MG/ML Injection
  • RxCUI: 884221 - clonidine HCl 1000 MCG per 10 ML Injection
  • RxCUI: 884225 - cloNIDine HCl 5000 MCG in 10 ML Injection
  • RxCUI: 884225 - 10 ML clonidine hydrochloride 0.5 MG/ML Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Zydus Lifesciences Limited
    Dosage Form:
    Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
    Administration Route(s):
  • Epidural - Administration upon or over the dura mater.
    • Active Ingredient(s):
  • CLONIDINE HYDROCHLORIDE .1 mg/mL
    • Pharmacologic Class(es):
  • Adrenergic alpha2-Agonists - [MoA] (Mechanism of Action)
  • Central alpha-2 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA202601
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    01-31-2018
    Listing Expiration Date:
    12-31-2024
    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 70771-1193-1?

    The NDC Packaged Code 70771-1193-1 is assigned to a package of 1 vial in 1 carton / 10 ml in 1 vial of Clonidine Hydrochloride, a human prescription drug labeled by Zydus Lifesciences Limited. The product's dosage form is injection, solution and is administered via epidural form.

    Is NDC 70771-1193 included in the NDC Directory?

    Yes, Clonidine Hydrochloride with product code 70771-1193 is active and included in the NDC Directory. The product was first marketed by Zydus Lifesciences Limited on January 31, 2018 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 70771-1193-1?

    The 11-digit format is 70771119301. 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 5-4-1 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
    5-4-170771-1193-15-4-270771-1193-01