Clonidine hydrochloride
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
70771-1193
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
150 mins
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