NDC Code(s) : 42291-601-01, 42291-602-01, 42291-603-01, 42291-604-01
Packager : AvKARE, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-601
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
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
CARBOXYMETHYLCELLULOSE SODIUM(UNII: K679OBS311)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
ETHYLCELLULOSE (10 MPA.S)(UNII: 3DYK7UYZ62)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
HYPROMELLOSES(UNII: 3NXW29V3WO)
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)(UNII: 6N003M473W)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
SUCROSE(UNII: C151H8M554)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color PINK Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code 18
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42291-601-01100 in 1 BOTTLE Type 0: Not a Combination Product27/02/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091695 10/01/2014 02/27/2017
Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-602
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 HYDROCHLORIDE27 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
CARBOXYMETHYLCELLULOSE SODIUM(UNII: K679OBS311)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
ETHYLCELLULOSE (10 MPA.S)(UNII: 3DYK7UYZ62)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
HYPROMELLOSES(UNII: 3NXW29V3WO)
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)(UNII: 6N003M473W)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
SUCROSE(UNII: C151H8M554)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color YELLOW Score no score
Shape OVAL Size 11 mm
Flavor Imprint Code 27
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42291-602-01100 in 1 BOTTLE Type 0: Not a Combination Product27/02/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091695 10/01/2014 02/27/2017
Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-603
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 HYDROCHLORIDE36 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
CARBOXYMETHYLCELLULOSE SODIUM(UNII: K679OBS311)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
ETHYLCELLULOSE (10 MPA.S)(UNII: 3DYK7UYZ62)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
HYPROMELLOSES(UNII: 3NXW29V3WO)
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)(UNII: 6N003M473W)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
SUCROSE(UNII: C151H8M554)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color PINK Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code 36
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42291-603-01100 in 1 BOTTLE Type 0: Not a Combination Product27/02/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091695 10/01/2014 02/27/2017
Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-604
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 HYDROCHLORIDE54 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
CARBOXYMETHYLCELLULOSE SODIUM(UNII: K679OBS311)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
ETHYLCELLULOSE (10 MPA.S)(UNII: 3DYK7UYZ62)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
HYPROMELLOSES(UNII: 3NXW29V3WO)
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)(UNII: 6N003M473W)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
SUCROSE(UNII: C151H8M554)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color PINK Score no score
Shape ROUND Size 14 mm
Flavor Imprint Code 54
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42291-604-01100 in 1 BOTTLE Type 0: Not a Combination Product27/02/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091695 10/01/2014 02/27/2017

PRINCIPAL DISPLAY PANEL

AvKARE

NDC 42291-601-01

Methylphenidate HCl Extended-Release Tablets, USP
CII

18 mg

100 Tablets        Rx Only

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Each tablet contains 18 mg methylphenidate hydrochloride in a controlled-release formulation.

Usual Dosage: Once daily.

See package insert for dosage information.

Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature]. Protect from humidity.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

L4229160101         AV  Rev. 06/15 (P)

N3   42291 60101   7

AvKARE

NDC 42291-602-01

Methylphenidate HCl Extended-Release Tablets, USP
CII

27 mg

100 Tablets        Rx Only

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Each tablet contains 27 mg methylphenidate hydrochloride in a controlled-release formulation.

Usual Dosage: Once daily.

See package insert for dosage information.

Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature]. Protect from humidity.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

L4229160201         AV Rev. 06/15 (P) 

N3   42291 60201   4

AvKARE

NDC 42291-603-01

Methylphenidate HCl Extended-Release Tablets, USP
CII

36 mg

100 Tablets        Rx Only

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Each tablet contains 36 mg methylphenidate hydrochloride in a controlled-release formulation.

Usual Dosage: Once daily.

See package insert for dosage information.

Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature]. Protect from humidity.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

L4229160301         AV Rev. 06/15 (P)

N3   42291 60301   1

AvKARE

NDC 42291-604-01

Methylphenidate HCl Extended-Release Tablets, USP
CII

54 mg

100 Tablets        Rx Only

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Each tablet contains 54 mg methylphenidate hydrochloride in a controlled-release formulation.

Usual Dosage: Once daily.

See package insert for dosage information.

Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature]. Protect from humidity.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

L4229160401         AV Rev. 06/15 (P) 

N3   42291 60401   8