NDC Code(s) : 59630-760-10, 59630-761-10, 59630-762-10
Packager : SHIONOGI INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

METHYLINmethylphenidate hydrochloride TABLET, CHEWABLE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59630-760
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLPHENIDATE HYDROCHLORIDE(UNII: 4B3SC438HI)
(METHYLPHENIDATE - UNII:207ZZ9QZ49) 		METHYLPHENIDATE HYDROCHLORIDE2.5 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME(UNII: Z0H242BBR1)
MALTOSE(UNII: XJ6S9RV06F)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
GUAR GUM(UNII: E89I1637KE)
STARCH, CORN(UNII: O8232NY3SJ)
STEARIC ACID(UNII: 4ELV7Z65AP)
Product Characteristics
Color WHITE (to cream) Score no score
Shape SQUARE Size 7 mm
Flavor GRAPE Imprint Code 2;5;CHEW
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59630-760-10100 in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021475 11/01/2010 01/01/2014
METHYLINmethylphenidate hydrochloride TABLET, CHEWABLE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59630-761
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLPHENIDATE HYDROCHLORIDE(UNII: 4B3SC438HI)
(METHYLPHENIDATE - UNII:207ZZ9QZ49) 		METHYLPHENIDATE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME(UNII: Z0H242BBR1)
MALTOSE(UNII: XJ6S9RV06F)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
GUAR GUM(UNII: E89I1637KE)
STARCH, CORN(UNII: O8232NY3SJ)
STEARIC ACID(UNII: 4ELV7Z65AP)
Product Characteristics
Color WHITE (to cream) Score no score
Shape SQUARE Size 8 mm
Flavor GRAPE Imprint Code 5;CHEW
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59630-761-10100 in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021475 11/01/2010 01/01/2014
METHYLINmethylphenidate hydrochloride TABLET, CHEWABLE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59630-762
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLPHENIDATE HYDROCHLORIDE(UNII: 4B3SC438HI)
(METHYLPHENIDATE - UNII:207ZZ9QZ49) 		METHYLPHENIDATE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME(UNII: Z0H242BBR1)
MALTOSE(UNII: XJ6S9RV06F)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
GUAR GUM(UNII: E89I1637KE)
STARCH, CORN(UNII: O8232NY3SJ)
STEARIC ACID(UNII: 4ELV7Z65AP)
Product Characteristics
Color WHITE (to cream) Score no score
Shape SQUARE Size 11 mm
Flavor GRAPE Imprint Code 10;CHEW
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59630-762-10100 in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021475 11/01/2010 01/01/2014

PRINCIPAL DISPLAY PANEL

NDC 59630-760-10

100 TABLETS

Methylin™
 Chewable Tablets
methylphenidate HCl chewable tablets

CII

2.5 mg Rx only

Each tablet contains: Methylphenidate Hydrochloride USP. . . . . . . 2.5 mg

PHARMACIST: PLEASE DISPENSE WITH
MEDICATION GUIDE PROVIDED WITH PRODUCT

SHIONOGI PHARMA, INC.

L00M46

10/2010

Principal Display Panel

PRINCIPAL DISPLAY PANEL

NDC 59630-761-10

100 TABLETS

Methylin™
 Chewable Tablets
methylphenidate HCl chewable tablets

CII

5 mg Rx only

Each tablet contains:
Methylphenidate Hydrochloride USP. . . . . . . 5 mg

PHARMACIST: PLEASE DISPENSE WITH
MEDICATION GUIDE PROVIDED WITH PRODUCT

SHIONOGI PHARMA, INC.

L00M50

10/2010

Principal Display Panel

PRINCIPAL DISPLAY PANEL

NDC 59630-762-10

100 TABLETS

Methylin™
Chewable Tablets
methylphenidate HCl chewable tablets

CII

10 mg Rx only

Each tablet contains:
Methylphenidate Hydrochloride USP. . . . . . . 10 mg

PHARMACIST: PLEASE DISPENSE WITH
MEDICATION GUIDE PROVIDED WITH PRODUCT

SHIONOGI PHARMA, INC.

L00M54

10/2010

Principal Display Panel