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 only100 Capsules

10 mg
(click image for full-size original)

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

20 mg
(click image for full-size original)

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

30 mg
(click image for full-size original)

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

40 mg
(click image for full-size original)

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

50 mg
(click image for full-size original)

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

60 mg
(click image for full-size original)

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: 05/2022 Teva Pharmaceuticals USA, Inc.

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