NDC 63481-042-85
API & Excipient Details

Homatropine Methylbromide marketed by Endo Pharmaceuticals, Inc. under NDC Code 63481-042-85

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROCODONE BITARTRATE(UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7)	HYDROCODONE BITARTRATE	5 mg
HOMATROPINE METHYLBROMIDE(UNII: 68JRS2HC1C) (METHYLHOMATROPINE - UNII:P97OGJ7L1L)	HOMATROPINE METHYLBROMIDE	1.5 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63481-042-70	100 in 1 BOTTLE Type 0: Not a Combination Product	23/03/1943
2	NDC:63481-042-85	500 in 1 BOTTLE Type 0: Not a Combination Product	23/03/1943

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROCODONE BITARTRATE(UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7)	HYDROCODONE BITARTRATE	5 mg in 5 mL
HOMATROPINE METHYLBROMIDE(UNII: 68JRS2HC1C) (METHYLHOMATROPINE - UNII:P97OGJ7L1L)	HOMATROPINE METHYLBROMIDE	1.5 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63481-234-16	473 mL in 1 BOTTLE Type 0: Not a Combination Product	23/03/1943

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA005213	03/23/1943	12/31/2008

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