NDC Code(s) : 63629-1231-1
Packager : Bryant Ranch Prepack

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Methylphenidate HydrochlorideMethylphenidate Hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-1231(NDC:31722-952)
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 HYDROCHLORIDE18 mg
Inactive Ingredients
Ingredient Name Strength
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
FD&C RED NO. 40(UNII: WZB9127XOA)
POLYETHYLENE OXIDE 200000(UNII: 11628IH70O)
POLYETHYLENE OXIDE 7000000(UNII: G3MS6M810Y)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
CELLULOSE ACETATE(UNII: 3J2P07GVB6)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
PHOSPHORIC ACID(UNII: E4GA8884NN)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
STEARIC ACID(UNII: 4ELV7Z65AP)
SUCCINIC ACID(UNII: AB6MNQ6J6L)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color yellow Score no score
Shape ROUND (cylindrical) Size 12 mm
Flavor Imprint Code 212
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63629-1231-1100 in 1 BOTTLE Type 0: Not a Combination Product21/12/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211009 09/03/2019

LABELER - Bryant Ranch Prepack(171714327)

REGISTRANT - Bryant Ranch Prepack(171714327)

Establishment
Name Address ID/FEI Business Operations
Bryant Ranch Prepack 171714327 repack(63629-1231), relabel(63629-1231)

PRINCIPAL DISPLAY PANEL

Methylphenidate Hcl ER 18 mg (CII) Tab#100

Label