NDC Code(s) : 59630-142-03
Packager : Shionogi Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Moxatagamoxicillin TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59630-142
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN(UNII: 804826J2HU)
(AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) 		AMOXICILLIN ANHYDROUS775 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POLYOXYL 35 CASTOR OIL(UNII: 6D4M1DAL6O)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
SHELLAC(UNII: 46N107B71O)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
FERRIC OXIDE RED(UNII: 1K09F3G675)
ALUMINUM OXIDE(UNII: LMI26O6933)
Product Characteristics
Color BLUE (BLUE) Score no score
Shape OVAL (OVAL) Size 22 mm
Flavor Imprint Code MB;111
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59630-142-0330 in 1 BOTTLE Type 0: Not a Combination Product26/08/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050813 08/26/2011 03/31/2014

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 59630-142-03
30 Tablets
92440771109
moxatag®
(amoxicillin extended-release tablets)
775 mg
SHIONOGI INC.
Rx only Rev. 08/11 MOX-BPI-1

PRINCIPAL DISPLAY PANEL NDC 59630-142-03 30 Tablets 92440771109 moxatag® (amoxicillin extended-release tablets) 775 mg SHIONOGI INC. Rx only Rev. 08/11 MOX-BPI-1