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Setid 540ef816 Eb03 469b 8b1d 99ce190fe6a3 Applno 18304 Form Injectable Injection Dosage 0 75 - Drug Product Composition: Marcaine

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

USFDA APPLICATION NUMBER - 18304 / DOSAGE - INJECTABLE;INJECTION - 0.75%

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPIVACAINE HYDROCHLORIDE(UNII: 7TQO7W3VT8)
(BUPIVACAINE - UNII:Y8335394RO)
BUPIVACAINE7.5mg in 1
EPINEPHRINE BITARTRATE(UNII: 30Q7KI53AK)
(EPINEPHRINE - UNII:YKH834O4BH)
EPINEPHRINE0.005mg 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
Hikma Pharmaceuticals USA Inc.
REMEDYREPACK INC.
Steriscience Specialties Private Limited
Terrain Pharmaceuticals
REMEDYREPACK INC.
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)