Methylphenidate Hydrochloride (CD) (Page 8 of 8)

PRINCIPAL DISPLAY PANEL

NDC 0093-5295 -01
Once Daily
Methylphenidate HCl Extended-Release Capsules (CD) CII
10 mg
PHARMACIST: Dispense the accompanying Medication Guide to each patient.
Rx only 100 Capsules

PRINCIPAL DISPLAY PANEL

NDC 0093-5296 -01
Once Daily
Methylphenidate HCl Extended-Release Capsules (CD) CII
20 mg
PHARMACIST: Dispense the accompanying Medication Guide to each patient.
Rx only100 Capsules

PRINCIPAL DISPLAY PANEL

NDC 0093-5297 -01
Once Daily
Methylphenidate HCl Extended-Release Capsules (CD) CII
30 mg
PHARMACIST: Dispense the accompanying Medication Guide to each patient.
Rx only100 Capsules

PRINCIPAL DISPLAY PANEL

NDC 0093-5298 -01
Once Daily
Methylphenidate HCl Extended-Release Capsules (CD) CII
40 mg
PHARMACIST: Dispense the accompanying Medication Guide to each patient.
Rx only100 Capsules

PRINCIPAL DISPLAY PANEL

NDC 0093-5292 -01
Once Daily
Methylphenidate HCl Extended-Release Capsules (CD) CII
50 mg
PHARMACIST: Dispense the accompanying Medication Guide to each patient.
Rx only100 Capsules

PRINCIPAL DISPLAY PANEL

NDC 0093-5293 -01
Once Daily
Methylphenidate HCl Extended-Release Capsules (CD) CII
60 mg
PHARMACIST: Dispense the accompanying Medication Guide to each patient.
Rx only100 Capsules

METHYLPHENIDATE HYDROCHLORIDE (CD) methylphenidate hydrochloride capsule, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-5295 Route of Administration ORAL DEA Schedule CII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE) METHYLPHENIDATE HYDROCHLORIDE 10 mg

Inactive Ingredients Ingredient Name Strength CETYL ALCOHOL STARCH, CORN D&C YELLOW NO. 10 ALUMINUM LAKE DIBUTYL SEBACATE ETHYLCELLULOSE, UNSPECIFIED FD&C BLUE NO. 1 ALUMINUM LAKE FD&C BLUE NO. 2–ALUMINUM LAKE FD&C RED NO. 40 GELATIN, UNSPECIFIED HYPROMELLOSE 2910 (5 MPA.S) FERROSOFERRIC OXIDE PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE SUCROSE TITANIUM DIOXIDE D&C YELLOW NO. 10 FD&C GREEN NO. 3

Product Characteristics Color white, green (light green) Score no score Shape CAPSULE Size 16mm Flavor Imprint Code 93;5295;93;5295 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0093-5295-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077707 09/27/2012

METHYLPHENIDATE HYDROCHLORIDE (CD) methylphenidate hydrochloride capsule, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-5296 Route of Administration ORAL DEA Schedule CII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE) METHYLPHENIDATE HYDROCHLORIDE 20 mg

Inactive Ingredients Ingredient Name Strength CETYL ALCOHOL STARCH, CORN D&C YELLOW NO. 10 ALUMINUM LAKE DIBUTYL SEBACATE ETHYLCELLULOSE, UNSPECIFIED FD&C BLUE NO. 1 ALUMINUM LAKE FD&C BLUE NO. 2–ALUMINUM LAKE FD&C RED NO. 40 GELATIN, UNSPECIFIED HYPROMELLOSE 2910 (5 MPA.S) FERROSOFERRIC OXIDE PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE SUCROSE TITANIUM DIOXIDE FD&C BLUE NO. 1

Product Characteristics Color white, blue (light turquoise blue) Score no score Shape CAPSULE Size 16mm Flavor Imprint Code 93;5296;93;5296 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0093-5296-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077707 09/27/2012

METHYLPHENIDATE HYDROCHLORIDE (CD) methylphenidate hydrochloride capsule, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-5297 Route of Administration ORAL DEA Schedule CII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE) METHYLPHENIDATE HYDROCHLORIDE 30 mg

Inactive Ingredients Ingredient Name Strength CETYL ALCOHOL STARCH, CORN D&C YELLOW NO. 10 ALUMINUM LAKE DIBUTYL SEBACATE ETHYLCELLULOSE, UNSPECIFIED FD&C BLUE NO. 1 ALUMINUM LAKE FD&C BLUE NO. 2–ALUMINUM LAKE FD&C RED NO. 40 GELATIN, UNSPECIFIED HYPROMELLOSE 2910 (5 MPA.S) FERROSOFERRIC OXIDE PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE SUCROSE TITANIUM DIOXIDE FERRIC OXIDE RED FERRIC OXIDE YELLOW

Product Characteristics Color white, brown (light brown) Score no score Shape CAPSULE Size 18mm Flavor Imprint Code 93;5297;93;5297 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0093-5297-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077707 09/27/2012

METHYLPHENIDATE HYDROCHLORIDE (CD) methylphenidate hydrochloride capsule, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-5298 Route of Administration ORAL DEA Schedule CII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE) METHYLPHENIDATE HYDROCHLORIDE 40 mg

Inactive Ingredients Ingredient Name Strength CETYL ALCOHOL STARCH, CORN D&C YELLOW NO. 10 ALUMINUM LAKE DIBUTYL SEBACATE ETHYLCELLULOSE, UNSPECIFIED FD&C BLUE NO. 1 ALUMINUM LAKE FD&C BLUE NO. 2–ALUMINUM LAKE FD&C RED NO. 40 GELATIN, UNSPECIFIED HYPROMELLOSE 2910 (5 MPA.S) FERROSOFERRIC OXIDE PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE SUCROSE TITANIUM DIOXIDE FERRIC OXIDE RED FERRIC OXIDE YELLOW

Product Characteristics Color white, brown (light brown) Score no score Shape CAPSULE Size 19mm Flavor Imprint Code 93;5298;93;5298 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0093-5298-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078873 09/27/2012

METHYLPHENIDATE HYDROCHLORIDE (CD) methylphenidate hydrochloride capsule, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-5292 Route of Administration ORAL DEA Schedule CII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE) METHYLPHENIDATE HYDROCHLORIDE 50 mg

Inactive Ingredients Ingredient Name Strength CETYL ALCOHOL STARCH, CORN D&C YELLOW NO. 10 ALUMINUM LAKE DIBUTYL SEBACATE ETHYLCELLULOSE, UNSPECIFIED FD&C BLUE NO. 1 ALUMINUM LAKE FD&C BLUE NO. 2–ALUMINUM LAKE FD&C RED NO. 40 GELATIN, UNSPECIFIED HYPROMELLOSE 2910 (5 MPA.S) FERROSOFERRIC OXIDE PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE SUCROSE TITANIUM DIOXIDE FD&C BLUE NO. 1

Product Characteristics Color white, blue (light blue) Score no score Shape CAPSULE Size 22mm Flavor Imprint Code 93;5292;93;5292 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0093-5292-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078873 09/27/2012

METHYLPHENIDATE HYDROCHLORIDE (CD) methylphenidate hydrochloride capsule, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-5293 Route of Administration ORAL DEA Schedule CII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE) METHYLPHENIDATE HYDROCHLORIDE 60 mg

Inactive Ingredients Ingredient Name Strength CETYL ALCOHOL STARCH, CORN D&C YELLOW NO. 10 ALUMINUM LAKE DIBUTYL SEBACATE ETHYLCELLULOSE, UNSPECIFIED FD&C BLUE NO. 1 ALUMINUM LAKE FD&C BLUE NO. 2–ALUMINUM LAKE FD&C RED NO. 40 GELATIN, UNSPECIFIED HYPROMELLOSE 2910 (5 MPA.S) FERROSOFERRIC OXIDE PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE SUCROSE TITANIUM DIOXIDE

Product Characteristics Color white Score no score Shape CAPSULE Size 22mm Flavor Imprint Code 93;5293;93;5293 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0093-5293-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078873 09/27/2012

Labeler — Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 11/2022 Teva Pharmaceuticals USA, Inc.