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FDA Drug information

Clonidine hydrochloride

Read time: 1 mins
Marketing start date: 29 Apr 2024
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Summary of product characteristics


Effective Time

20211129

Version

5

Spl Product Data Elements

clonidine hydrochloride clonidine hydrochloride CLONIDINE HYDROCHLORIDE CLONIDINE SODIUM CHLORIDE clonidine hydrochloride clonidine hydrochloride CLONIDINE HYDROCHLORIDE CLONIDINE SODIUM CHLORIDE

Application Number

ANDA202601

Brand Name

Clonidine hydrochloride

Generic Name

clonidine hydrochloride

Product Ndc

70771-1194

Product Type

HUMAN PRESCRIPTION DRUG

Route

EPIDURAL

Package Label Principal Display Panel

PRINCIPAL DISPLAY PANEL – 100 mcg/mL Container Label NDC 70771-1193-1 Clonidine Hydrochloride Injection 1000 mcg/10 mL (100 mcg/mL) For Epidural Injection Rx only 10 mL Single-Dose Vial Zydus pharmaceuticals PRINCIPAL DISPLAY PANEL – 100 mcg/mL Carton Label Rx only Zydus pharmaceuticals NDC 70771-1193-1 Clonidine Hydrochloride Injection 1000 mcg/10 mL (100 mcg/mL) For Epidural Injection 10 mL Single-Dose Vial PRINCIPAL DISPLAY PANEL – 500 mcg/mL Container Label NDC 70771-1194-1 Clonidine Hydrochloride Injection 5000 mcg/10 mL (500 mcg/mL) For Epidural Injection MUST BE DILUTED BEFORE USE Rx only 10 mL Single-Dose Vial Zydus pharmaceuticals PRINCIPAL DISPLAY PANEL – 500 mcg/mL Carton Label Rx only Zydus pharmaceuticals NDC 70771-1194-1 Clonidine Hydrochloride Injection 5000 mcg/10 mL (500 mcg/mL) For Epidural Injection MUST BE DILUTED BEFORE USE 10 mL Single-Dose Vial Clonidine Hydrochloride Injection, 0.1mg/mL, vial Label Clonidine Hydrochloride Injection, 0.1mg/mL, Carton Label Clonidine Hydrochloride Injection 0.5 mg/mL, Vial Label Clonidine Hydrochloride Injection 0.5 mg/mL, Carton Label

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Disclaimer

The drug Prescribing Information (PI), including indications, contra-indications, interactions, etc, has been developed using the U.S. Food & Drug Administration (FDA) as a source (www.fda.gov).

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Drugs appearing in this section are approved by the FDA. For regions outside of the United States, this content is for informational purposes only and may not be aligned with local regulatory approvals or guidance.