POSIMIR- bupivacaine injection

POSIMIR by

Drug Labeling and Warnings

POSIMIR by is a Prescription medication manufactured, distributed, or labeled by Renaissance Lakewood, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Product Label

PRINCIPAL DISPLAY PANEL

Product Vial

Product Carton

INGREDIENTS AND APPEARANCE

POSIMIR 
bupivacaine injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 49396-6601
Route of Administration	INFILTRATION

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BUPIVACAINE (UNII: Y8335394RO) (BUPIVACAINE - UNII:Y8335394RO)	BUPIVACAINE	660 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
SUCROSE ACETATE ISOBUTYRATE (UNII: H5KI1C3YTV)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49396-6601-0	10 in 1 CARTON	05/31/2022
1		5 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA204803	05/31/2022

Labeler - Renaissance Lakewood, LLC (077744035)

Registrant - Renaissance Lakewood, LLC (077744035)