NDC Code(s) : 70010-012-01, 70010-013-01, 70010-014-01, 70010-015-01, 70010-016-03
Packager : Granules Pharmaceuticals Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Methylphenidate HydrochlorideMethylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70010-012
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
ACETYLTRIBUTYL CITRATE(UNII: 0ZBX0N59RZ)
AMMONIA(UNII: 5138Q19F1X)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
CELLABURATE (MW 65000, 17% BUTYRYL, 30% ACETYL)(UNII: BEI30UXK2N)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
GELATIN(UNII: 2G86QN327L)
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)(UNII: 6N003M473W)
POLYETHYLENE GLYCOL(UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: MB5IUD6JUA)
STARCH, CORN(UNII: O8232NY3SJ)
SUCROSE(UNII: C151H8M554)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color yellow (yellow-white) Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code G10mg;012
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70010-012-01100 in 1 BOTTLE Type 0: Not a Combination Product09/10/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211796 09/10/2019
Methylphenidate HydrochlorideMethylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70010-013
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 HYDROCHLORIDE20 mg
Inactive Ingredients
Ingredient Name Strength
ACETYLTRIBUTYL CITRATE(UNII: 0ZBX0N59RZ)
CELLABURATE (MW 65000, 17% BUTYRYL, 30% ACETYL)(UNII: BEI30UXK2N)
GELATIN(UNII: 2G86QN327L)
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)(UNII: 6N003M473W)
POLYETHYLENE GLYCOL(UNII: 3WJQ0SDW1A)
STARCH, CORN(UNII: O8232NY3SJ)
SUCROSE(UNII: C151H8M554)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
AMMONIA(UNII: 5138Q19F1X)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color white Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code G20mg;013
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70010-013-01100 in 1 BOTTLE Type 0: Not a Combination Product09/10/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211796 09/10/2019
Methylphenidate HydrochlorideMethylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70010-014
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 HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient Name Strength
ACETYLTRIBUTYL CITRATE(UNII: 0ZBX0N59RZ)
CELLABURATE (MW 65000, 17% BUTYRYL, 30% ACETYL)(UNII: BEI30UXK2N)
GELATIN(UNII: 2G86QN327L)
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)(UNII: 6N003M473W)
POLYETHYLENE GLYCOL(UNII: 3WJQ0SDW1A)
STARCH, CORN(UNII: O8232NY3SJ)
SUCROSE(UNII: C151H8M554)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
AMMONIA(UNII: 5138Q19F1X)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color yellow Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code G30mg;014
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70010-014-01100 in 1 BOTTLE Type 0: Not a Combination Product09/10/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211796 09/10/2019
Methylphenidate HydrochlorideMethylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70010-015
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 HYDROCHLORIDE40 mg
Inactive Ingredients
Ingredient Name Strength
ACETYLTRIBUTYL CITRATE(UNII: 0ZBX0N59RZ)
CELLABURATE (MW 65000, 17% BUTYRYL, 30% ACETYL)(UNII: BEI30UXK2N)
GELATIN(UNII: 2G86QN327L)
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)(UNII: 6N003M473W)
POLYETHYLENE GLYCOL(UNII: 3WJQ0SDW1A)
STARCH, CORN(UNII: O8232NY3SJ)
SUCROSE(UNII: C151H8M554)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
AMMONIA(UNII: 5138Q19F1X)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color yellow Score no score
Shape CAPSULE Size 22 mm
Flavor Imprint Code G40mg;015
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70010-015-01100 in 1 BOTTLE Type 0: Not a Combination Product09/10/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211796 09/10/2019
Methylphenidate HydrochlorideMethylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70010-016
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 HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient Name Strength
ACETYLTRIBUTYL CITRATE(UNII: 0ZBX0N59RZ)
CELLABURATE (MW 65000, 17% BUTYRYL, 30% ACETYL)(UNII: BEI30UXK2N)
GELATIN(UNII: 2G86QN327L)
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)(UNII: 6N003M473W)
POLYETHYLENE GLYCOL(UNII: 3WJQ0SDW1A)
STARCH, CORN(UNII: O8232NY3SJ)
SUCROSE(UNII: C151H8M554)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
AMMONIA(UNII: 5138Q19F1X)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color yellow Score no score
Shape CAPSULE Size 23 mm
Flavor Imprint Code G60mg;016
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70010-016-0330 in 1 BOTTLE Type 0: Not a Combination Product09/10/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211796 09/10/2019

LABELER - Granules Pharmaceuticals Inc.(079825711)

Establishment
Name Address ID/FEI Business Operations
Granules Pharmaceuticals Inc. 079825711 manufacture(70010-012, 70010-013, 70010-014, 70010-015, 70010-016), label(70010-014, 70010-012, 70010-013, 70010-015, 70010-016), analysis(70010-012, 70010-013, 70010-014, 70010-015, 70010-016), pack(70010-012, 70010-013, 70010-014, 70010-015, 70010-016)

PRINCIPAL DISPLAY PANEL

methylphenidate-10mg-labelmethylphenidate-10mg-labelmethylphenidate-10mg-labelmethylphenidate-10mg-labelmethylphenidate-10mg-label