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FDA Approval

Xodol

CompanyRebel Distributors Corp (DUNS: 118802834)

Effective Date

March 20, 2012

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Hydrocodone(7.5 mg in 1 1)

Acetaminophen(300 mg in 1 1)

Manufacturing Establishments (1)

Rebel Distributors Corp

Labeler

Rebel Distributors Corp

DUNS Number

118802834

Products (1)

Xodol

NDC Product Code

42254-114

Application Number

ANDA040556

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 20, 2010

Ingredients

HydrocodoneActive

Code: NO70W886KKClass: ACTIBQuantity: 7.5 mg in 1 1

AcetaminophenActive

Code: 362O9ITL9DClass: ACTIBQuantity: 300 mg in 1 1

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

CROSPOVIDONEInactive

Code: 68401960MKClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

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