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Setid 8db7c501 993a 444d A819 D1f9df1d7b62 Applno 16964 Form Injectable Injection Dosage 0 25 - Drug Product Composition: Marcaine

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$ API Ref.Price (USD/KG) : 862Xls

USFDA APPLICATION NUMBER - 16964 / DOSAGE - INJECTABLE;INJECTION - 0.25%

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Bupivacaine Hydrochloride(UNII: 7TQO7W3VT8)
(Bupivacaine - UNII:Y8335394RO)
Bupivacaine Hydrochloride5mg in 1

Inactive Ingredients

Ingredient Name
General Injectables & Vaccines, Inc.
Cardinal Health
RX PHARMA-PACK, INC.
Hospira, Inc.
A-S Medication Solutions
A-S Medication Solutions LLC
AuroMedics Pharma LLC
Cardinal Health 107, LLC
Hikma Pharmaceuticals USA Inc.
REMEDYREPACK INC.
Steriscience Specialties Private Limited
Terrain Pharmaceuticals
ASCORBIC ACID(PQ6CK8PD0R)           
CITRIC ACID MONOHYDRATE(2968PHW8QP)          
EDETATE CALCIUM DISODIUM ANHYDROUS(8U5D034955)           
EDETATE CALCIUM DISODIUM(25IH6R4SGF)           
HYDROCHLORIC ACID(QTT17582CB)
METHYLPARABEN(A2I8C7HI9T)        
MONOTHIOGLYCEROL(AAO1P0WSXJ)           
NONOXYNOL-9(48Q180SH9T)           
SODIUM CHLORIDE(451W47IQ8X)
SODIUM HYDROXIDE(55X04QC32I)
SODIUM LACTATE(TU7HW0W0QT)           
SODIUM METABISULFITE(4VON5FNS3C)         
SODIUM PHOSPHATE, DIBASIC(GR686LBA74)           
WATER(059QF0KO0R)