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Drug Product Composition: Hydrocodone Bitartrate

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USFDA APPLICATION NUMBER - 22439 / DOSAGE - SOLUTION;ORAL - 4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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
PSEUDOEPHEDRINE HYDROCHLORIDE(UNII: 6V9V2RYJ8N)
(PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)
PSEUDOEPHEDRINE HYDROCHLORIDE60mg in 5

Inactive Ingredients

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