Clonidine Hydrochloride Injection

PRINCIPAL DISPLAY PANEL – 100 mcg/mL Container Label

NDC 70771-1193-1

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

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

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

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

CLONIDINE HYDROCHLORIDE
clonidine hydrochloride injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1193
Route of Administration	EPIDURAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CLONIDINE HYDROCHLORIDE (UNII: W76I6XXF06) (CLONIDINE - UNII:MN3L5RMN02)	CLONIDINE HYDROCHLORIDE	0.1 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM CHLORIDE (UNII: 451W47IQ8X)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1193-1	1 in 1 CARTON	01/31/2018
1		10 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CLONIDINE HYDROCHLORIDE (UNII: W76I6XXF06) (CLONIDINE - UNII:MN3L5RMN02)	CLONIDINE HYDROCHLORIDE	0.5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM CHLORIDE (UNII: 451W47IQ8X)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1194-1	1 in 1 CARTON	01/31/2018
1		10 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA202601	01/31/2018

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		918596198	ANALYSIS(70771-1193, 70771-1194) , MANUFACTURE(70771-1193, 70771-1194)