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Drug Product Composition: Hydrocodone

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USFDA APPLICATION NUMBER - 205474 / DOSAGE - SOLUTION;ORAL - 200MG/5ML;2.5MG/5ML

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GUAIFENESIN(UNII: 495W7451VQ)
(GUAIFENESIN - UNII:495W7451VQ)
GUAIFENESIN200mg in 5
HYDROCODONE BITARTRATE(UNII: NO70W886KK)
(HYDROCODONE - UNII:6YKS4Y3WQ7)
HYDROCODONE BITARTRATE2.5mg in 5

Inactive Ingredients

Ingredient Name
Burke Therapeutics
Mission Pharmacal Company
NOVOTEC PHARMA LLC
CITRIC ACID MONOHYDRATE(2968PHW8QP)
D&C RED NO. 33(9DBA0SBB0L)  
FD&C BLUE NO. 1(H3R47K3TBD)  
GLYCERIN(PDC6A3C0OX)
METHYLPARABEN(A2I8C7HI9T)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)  
POTASSIUM CITRATE(EE90ONI6FF) 
POTASSIUM SORBATE(1VPU26JZZ4) 
PROPYLENE GLYCOL(6DC9Q167V3) 
PROPYLPARABEN(Z8IX2SC1OH)
SACCHARIN SODIUM(SB8ZUX40TY)
SODIUM CITRATE(1Q73Q2JULR)  
SORBITOL(506T60A25R)  
WATER(059QF0KO0R)