Clonidine Hydrochloride

CLONIDINE HYDROCHLORIDE — clonidine hydrochloride injection, solution
Zydus Lifesciences Limited

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

Clonidine Hydrochloride Injection, 0.1mg/mL, vial Label
(click image for full-size original)

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

Clonidine Hydrochloride Injection, 0.1mg/mL,  Carton Label
(click image for full-size original)

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

Clonidine Hydrochloride Injection 0.5 mg/mL, Vial Label
(click image for full-size original)

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 0.5 mg/mL, Carton Label
(click image for full-size original)
CLONIDINE HYDROCHLORIDE
clonidine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1193
Route of Administration EPIDURAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLONIDINE HYDROCHLORIDE (CLONIDINE) CLONIDINE HYDROCHLORIDE 0.1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1193-1 1 VIAL in 1 CARTON contains a VIAL
1 10 mL in 1 VIAL This package is contained within the CARTON (70771-1193-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202601 01/31/2018
CLONIDINE HYDROCHLORIDE
clonidine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1194
Route of Administration EPIDURAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLONIDINE HYDROCHLORIDE (CLONIDINE) CLONIDINE HYDROCHLORIDE 0.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1194-1 1 VIAL in 1 CARTON contains a VIAL
1 10 mL in 1 VIAL This package is contained within the CARTON (70771-1194-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202601 01/31/2018
Labeler — Zydus Lifesciences Limited (918596198)
Registrant — Zydus Lifesciences Limited (918596198)
Establishment
Name Address ID/FEI Operations
Zydus Lifesciences Limited 918596198 ANALYSIS (70771-1193), ANALYSIS (70771-1194), MANUFACTURE (70771-1193), MANUFACTURE (70771-1194)

Revised: 11/2021 Zydus Lifesciences Limited

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