NDC Code(s) : 63481-042-70, 63481-042-85, 63481-234-16
Packager : Endo Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

HycodanHydrocodone Bitartrate and Homatropine Methylbromide TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63481-042
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 BITARTRATE5 mg
HOMATROPINE METHYLBROMIDE(UNII: 68JRS2HC1C)
(METHYLHOMATROPINE - UNII:P97OGJ7L1L) 		HOMATROPINE METHYLBROMIDE1.5 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS(UNII: L11K75P92J)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
LACTOSE(UNII: J2B2A4N98G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
STARCH, CORN(UNII: O8232NY3SJ)
STEARIC ACID(UNII: 4ELV7Z65AP)
Product Characteristics
Color WHITE (WHITE) Score 2 pieces
Shape ROUND (ROUND) Size 8 mm
Flavor Imprint Code HYCODAN
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63481-042-70100 in 1 BOTTLE Type 0: Not a Combination Product23/03/1943
2NDC:63481-042-85500 in 1 BOTTLE Type 0: Not a Combination Product23/03/1943
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA005213 03/23/1943 01/31/2009
HycodanHydrocodone Bitartrate and Homatropine Methylbromide SYRUP
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63481-234
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 BITARTRATE5 mg in 5 mL
HOMATROPINE METHYLBROMIDE(UNII: 68JRS2HC1C)
(METHYLHOMATROPINE - UNII:P97OGJ7L1L) 		HOMATROPINE METHYLBROMIDE1.5 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
CARAMEL(UNII: T9D99G2B1R)
FD&C RED NO. 40(UNII: WZB9127XOA)
SUGARCANE(UNII: 81H2R5AOH3)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
SORBITOL(UNII: 506T60A25R)
CHERRY(UNII: BUC5I9595W)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63481-234-16473 mL in 1 BOTTLE Type 0: Not a Combination Product23/03/1943
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA005213 03/23/1943 12/31/2008

PRINCIPAL DISPLAY PANEL

 Package Label – Principle Display Panel – Bottle Label - Tablets

PRINCIPAL DISPLAY PANEL

 Package Label – Principle Display Panel – Carton Label - Tablets

PRINCIPAL DISPLAY PANEL

 Package Label – Principle Display Panel – Oral Solution Label