NDC Code(s) : 49884-235-33, 49884-235-37
Packager : Par Pharmaceutical Companies Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Hydrocodone Polistirex and Chlorpheniramine PolisitrexHydrocodone Polistirex and Chlorpheniramine Polisitrex SUSPENSION, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-235
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCODONE BITARTRATE(UNII: NO70W886KK)
(HYDROCODONE - UNII:6YKS4Y3WQ7) 		HYDROCODONE BITARTRATE10 mg in 5 mL
CHLORPHENIRAMINE MALEATE(UNII: V1Q0O9OJ9Z)
(CHLORPHENIRAMINE - UNII:3U6IO1965U) 		CHLORPHENIRAMINE MALEATE8 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM POLYSTYRENE SULFONATE(UNII: 1699G8679Z)
WATER(UNII: 059QF0KO0R)
VINYL ACETATE(UNII: L9MK238N77)
TRIACETIN(UNII: XHX3C3X673)
SODIUM METABISULFITE(UNII: 4VON5FNS3C)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
XANTHAN GUM(UNII: TTV12P4NEE)
ASCORBIC ACID(UNII: PQ6CK8PD0R)
SODIUM ASCORBATE(UNII: S033EH8359)
HIGH FRUCTOSE CORN SYRUP(UNII: XY6UN3QB6S)
SUCROSE(UNII: C151H8M554)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)(UNII: 461P5CJN6T)
Product Characteristics
Color YELLOW Score
Shape Size
Flavor PINEAPPLE Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49884-235-33473 mL in 1 BOTTLE Type 0: Not a Combination Product
2NDC:49884-235-37115 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091632 08/16/2012

PRINCIPAL DISPLAY PANEL

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