Metadate CD (Page 6 of 6)

PRINCIPAL DISPLAY PANEL — 10 mg Capsule Label

Once Daily

Metadate CD ®
(methylphenidate HCl, USP)
Extended-Release Capsules
CII

10 mg


A Medication Guide is required for every prescription dispensed.

Please use accompanying Medication Guide.

Rx Only

Principal Display Panel -- 10 mg Capsule Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 20 mg Capsule Label

Once Daily

Metadate CD ®
(methylphenidate HCl, USP)
Extended-Release Capsules
CII

20 mg


A Medication Guide is required for every prescription dispensed.

Please use accompanying Medication Guide.

Rx Only

Principal Display Panel -- 20 mg Capsule Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 30 mg Capsule Label

Once Daily

Metadate CD ®
(methylphenidate HCl, USP)
Extended-Release Capsules
CII


30 mg

Rx Only

A Medication Guide is required
for every prescription dispensed.

Please use accompanying Medication Guide.

Principal Display Panel -- 30 mg Capsule Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 50 mg Capsule Label

Once Daily

Metadate CD ®
(methylphenidate HCl, USP)
Extended-Release Capsules
CII

50 mg

Rx Only


A Medication Guide is required for every prescription dispensed.

Please use accompanying Medication Guide.

Principal Display Panel -- 50 mg Capsule Label
(click image for full-size original)
METADATE CD methylphenidate hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5397(NDC:53014-579)
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
POVIDONE
HYPROMELLOSES
POLYETHYLENE GLYCOL
ETHYLCELLULOSES
DIBUTYL SEBACATE
GELATIN
TITANIUM DIOXIDE
FD&C BLUE NO. 2
FERRIC OXIDE YELLOW
Product Characteristics
Color white (White) , green (Green) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code UCB;579;10;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5397-0 30 CAPSULE, EXTENDED RELEASE (CAPSULE) in 1 BOTTLE, PLASTIC None
2 NDC:54868-5397-1 10 CAPSULE, EXTENDED RELEASE (CAPSULE) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021259 08/26/2005
METADATE CD methylphenidate hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4718(NDC:53014-580)
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
POVIDONE
HYPROMELLOSES
POLYETHYLENE GLYCOL
ETHYLCELLULOSES
DIBUTYL SEBACATE
GELATIN
TITANIUM DIOXIDE
FD&C BLUE NO. 2
Product Characteristics
Color blue (Blue) , white (White) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code UCB;580;20;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-4718-0 30 CAPSULE, EXTENDED RELEASE (CAPSULE) in 1 BOTTLE, PLASTIC None
2 NDC:54868-4718-1 10 CAPSULE, EXTENDED RELEASE (CAPSULE) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021259 12/23/2002
METADATE CD methylphenidate hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-0668(NDC:53014-581)
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
POVIDONE
HYPROMELLOSES
POLYETHYLENE GLYCOL
ETHYLCELLULOSES
DIBUTYL SEBACATE
GELATIN
TITANIUM DIOXIDE
FD&C BLUE NO. 2
FERRIC OXIDE RED
Product Characteristics
Color red (Reddish-brown) , white (White) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code UCB;581;30;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-0668-0 30 CAPSULE, EXTENDED RELEASE (CAPSULE) in 1 BOTTLE, PLASTIC None
2 NDC:54868-0668-1 10 CAPSULE, EXTENDED RELEASE (CAPSULE) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021259 08/26/2005
METADATE CD methylphenidate hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-6234(NDC:53014-583)
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
POVIDONE
HYPROMELLOSES
POLYETHYLENE GLYCOL
ETHYLCELLULOSES
DIBUTYL SEBACATE
GELATIN
TITANIUM DIOXIDE
FD&C BLUE NO. 2
FERRIC OXIDE RED
Product Characteristics
Color purple (Purple) , white (White) Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code UCB;583;50;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-6234-0 30 CAPSULE, EXTENDED RELEASE (CAPSULE) in 1 BOTTLE, PLASTIC None
2 NDC:54868-6234-1 10 CAPSULE, EXTENDED RELEASE (CAPSULE) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021259 03/02/2011
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel, repack

Revised: 11/2010 Physicians Total Care, Inc.

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