NDC Code(s) : 60687-140-11, 60687-140-21, 60687-151-95, 60687-151-25
Packager : American Health Packaging

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Methylphenidate Hydrochloride Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-140(NDC:0093-5295)
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
CETYL ALCOHOL(UNII: 936JST6JCN)
STARCH, CORN(UNII: O8232NY3SJ)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
DIBUTYL SEBACATE(UNII: 4W5IH7FLNY)
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C RED NO. 40(UNII: WZB9127XOA)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SUCROSE(UNII: C151H8M554)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C GREEN NO. 3(UNII: 3P3ONR6O1S)
ALUMINUM OXIDE(UNII: LMI26O6933)
Product Characteristics
Color white, green (light green) Score no score
Shape CAPSULE Size 16 mm
Flavor Imprint Code 93;5295;93;5295
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60687-140-2130 in 1 BOX, UNIT-DOSE 08/03/2015
1NDC:60687-140-111 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077707 08/03/2015 08/31/2018
Methylphenidate Hydrochloride Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-151(NDC:0093-5297)
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
CETYL ALCOHOL(UNII: 936JST6JCN)
STARCH, CORN(UNII: O8232NY3SJ)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
DIBUTYL SEBACATE(UNII: 4W5IH7FLNY)
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C RED NO. 40(UNII: WZB9127XOA)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SUCROSE(UNII: C151H8M554)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
ALUMINUM OXIDE(UNII: LMI26O6933)
Product Characteristics
Color white, brown (light brown) Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code 93;5297;93;5297
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60687-151-2530 in 1 BOX, UNIT-DOSE 23/10/2015
1NDC:60687-151-951 in 1 BOX, UNIT-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077707 10/23/2015 08/31/2018

PRINCIPAL DISPLAY PANEL

10 mg Methylphenidate HCl ER Capsules Carton

NDC 60687-140-21

Once Daily
Methylphenidate HCl
Extended-Release Capsules (CD)

CII

10 mg

30 Capsules (3 x 10)

PHARMACIST: Dispense with the accompanying
Medication Guide to each patient.

Each Extended-Release Capsule Contains:
Methylphenidate Hydrochloride, USP ……….. 10 mg

Usual Dosage: See package insert for full prescribing
information.

Do not chew or crush the capsules or the beads inside
the capsule.

Store at 20° to 25°C (68° to 77°F); excursions permitted
between 15° to 30°C (59° to 86°F) [see USP Controlled
Room Temperature].

DEA Order Form Required.

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or
broken.

Rx Only

The drug product contained in this package is
from NDC # 0093-5295, Teva Pharmaceuticals
USA, Inc.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

714021
0414021/0116

PRINCIPAL DISPLAY PANEL

10 mg Methylphenidate HCl Capsule Blister

Once Daily
Methylphenidate
HCl
Extended-Release
Capsule (CD)

CII

10 mg

PRINCIPAL DISPLAY PANEL

30 mg Methylphenidate HCl ER Capsules Carton

NDC 60687-151-25

Once Daily
Methylphenidate HCl
Extended-Release
Capsules (CD)

CII

30 mg

30 Capsules (5 x 6)

PHARMACIST: Dispense with the accompanying
Medication Guide to each patient.

Each Extended-Release Capsule Contains:
Methylphenidate hydrochloride, USP ……….. 30 mg

Usual Dosage: See package insert for full
prescribing information.

Do not chew or crush the capsules or the beads
inside the capsule.

Store at 20° to 25°C (68° to 77°F); excursions
permitted between 15° to 30°C (59° to 86°F) [see
USP Controlled Room Temperature].

DEA Order Form Required.

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is
torn or broken.

Rx Only

The drug product contained in this
package is from NDC # 0093-5297,
Teva Pharmaceuticals USA, Inc.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

715125
0415125/1115

PRINCIPAL DISPLAY PANEL

30 mg Methylphenidate HCl Capsule Blister

Once Daily
Methylphenidate
HCl
Extended-Release
Capsule (CD)

CII

30 mg