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Drug Product Composition: Hydrocodone

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USFDA APPLICATION NUMBER - 204307 / DOSAGE - SOLUTION;ORAL - 4MG/5ML;5MG/5ML

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORPHENIRAMINE MALEATE(UNII: V1Q0O9OJ9Z)
(CHLORPHENIRAMINE - UNII:3U6IO1965U)
CHLORPHENIRAMINE MALEATE4mg in 5
HYDROCODONE BITARTRATE(UNII: NO70W886KK)
(HYDROCODONE - UNII:6YKS4Y3WQ7)
HYDROCODONE BITARTRATE5mg in 5

Inactive Ingredients

Ingredient Name
Acella Pharmaceuticals, LLC
Hawthorn Pharmaceuticals, Inc.
Tris Pharma Inc
ANHYDROUS CITRIC ACID(XF417D3PSL)
GLYCERIN(PDC6A3C0OX)
GRAPE(6X543N684K)  
METHYLPARABEN(A2I8C7HI9T)
PROPYLENE GLYCOL(6DC9Q167V3)
PROPYLPARABEN(Z8IX2SC1OH)
SACCHARIN SODIUM(SB8ZUX40TY)
SODIUM CITRATE(1Q73Q2JULR)
SUCROSE(C151H8M554)
WATER(059QF0KO0R)