Minds On Meds

Mental Health Medications

ADHD Medications

Focalin XR, Page 4

Focalin XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older. The effectiveness of Focalin XR in the treatment of ADHD in patients aged 6 years and older was established in two…

PACKAGE LABEL — FOCALIN XR C-II CAPSULE

Label Image
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FOCALIN XR
dexmethylphenidate hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16590-649(NDC:0078-0493)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE) DEXMETHYLPHENIDATE HYDROCHLORIDE 15 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 2
FERRIC OXIDE YELLOW
GELATIN
POLYETHYLENE GLYCOL
DEXTROSE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color green Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code NVR;D15
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16590-649-30 30 CAPSULE, EXTENDED RELEASE (CAPSULE) in 1 BOTTLE None
2 NDC:16590-649-60 60 CAPSULE, EXTENDED RELEASE (CAPSULE) in 1 BOTTLE None
3 NDC:16590-649-90 90 CAPSULE, EXTENDED RELEASE (CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021802 05/31/2005
Labeler — STAT RX USA LLC (786036330)
Establishment
Name Address ID/FEI Operations
STAT RX USA LLC 786036330 relabel, repack

Revised: 06/2011 STAT RX USA LLC