Label: DEXMEDETOMIDINE HYDROCHLORIDE injection, solution, concentrate
- NDC Code(s): 70771-1319-1, 70771-1319-7
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 17, 2022
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- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL
NDC 70771-1319-1
Dexmedetomidine
Hydrochloride Injection
200 mcg/2 mL
(100 mcg/mL)
For Intravenous Infusion Use
MUST BE DILUTED
2 mL Single-Dose Vial
Rx only
Zydus Pharmaceuticals
PRINCIPAL DISPLAY PANEL - 200 MCG/2 ML CARTON LABEL
NDC 70771-1319-7
Dexmedetomidine
Hydrochloride Injection
200 mcg/2 mL
(100 mcg/mL)
For Intravenous Infusion Use
MUST BE DILUTED
25 X 2 mL Single-Dose Vials
Rx only
Zydus Pharmaceuticals
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INGREDIENTS AND APPEARANCE
DEXMEDETOMIDINE HYDROCHLORIDE
dexmedetomidine hydrochloride injection, solution, concentrateProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1319 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXMEDETOMIDINE HYDROCHLORIDE (UNII: 1018WH7F9I) (DEXMEDETOMIDINE - UNII:67VB76HONO) DEXMEDETOMIDINE 100 ug in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 9 mg in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1319-7 25 in 1 CARTON 06/14/2018 1 NDC:70771-1319-1 2 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 ANDA206798 06/14/2018 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(70771-1319) , MANUFACTURE(70771-1319)