Label: CLONIDINE HYDROCHLORIDE injection, solution
- NDC Code(s): 70771-1193-1, 70771-1194-1
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 29, 2021
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- SPL UNCLASSIFIED SECTION
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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
-
INGREDIENTS AND APPEARANCE
CLONIDINE HYDROCHLORIDE
clonidine hydrochloride injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1193 Route of Administration EPIDURAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLONIDINE HYDROCHLORIDE (UNII: W76I6XXF06) (CLONIDINE - UNII:MN3L5RMN02) CLONIDINE HYDROCHLORIDE 0.1 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202601 01/31/2018 CLONIDINE HYDROCHLORIDE
clonidine hydrochloride injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1194 Route of Administration EPIDURAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLONIDINE HYDROCHLORIDE (UNII: W76I6XXF06) (CLONIDINE - UNII:MN3L5RMN02) CLONIDINE HYDROCHLORIDE 0.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 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 Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(70771-1193, 70771-1194) , MANUFACTURE(70771-1193, 70771-1194)