Xanax XR (Page 7 of 7)

Switch from XANAX (immediate-release) Tablets to XANAX XR (extended-release) Tablets

Patients who are currently being treated with divided doses of XANAX (immediate-release) Tablets, for example 3 to 4 times a day, may be switched to XANAX XR Tablets at the same total daily dose taken once daily. If the therapeutic response after switching is inadequate, the dosage may be titrated as outlined above.

HOW SUPPLIED

XANAX XR (extended-release) Tablets are available as follows:
0.5 mg (white, pentagonal-shaped tablets debossed with an “X” on one side and “0.5″ on the other side)
Bottles of 60 NDC 0009-0057-07
1 mg (yellow, square-shaped tablets debossed with an “X” on one side and “1″ on the other side)
Bottles of 60 NDC 0009-0059-07
2 mg (blue, round-shaped tablets debossed with an “X” on one side and “2″ on the other side)
Bottles of 60 NDC 0009-0066-07
3 mg (green, triangular-shaped tablets debossed with an “X” on one side and “3″ on the other side)
Bottles of 60 NDC 0009-0068-07

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

ANIMAL STUDIES

When rats were treated with alprazolam at 3, 10, and 30 mg/kg/day (15 to 150 times the maximum recommended human dose) orally for 2 years, a tendency for a dose related increase in the number of cataracts was observed in females and a tendency for a dose related increase in corneal vascularization was observed in males. These lesions did not appear until after 11 months of treatment.

This product’s label may have been updated. For current full prescribing information, please visit www.pfizer.com.

Logo

LAB-0006-7.0
September 2013

PRINCIPAL DISPLAY PANEL — 0.5 mg Tablet Bottle Label

Pfizer

NDC 0009-0057-07

Xanax XR®
alprazolam
CIV
0.5 mg
extended-release tablets

60 TabletsRx only

Principal Display Panel -- 0.5 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 1 mg Tablet Bottle Label

Pfizer

NDC 0009-0059-07

Xanax XR®
alprazolam
CIV
1 mg
extended-release tablets

60 TabletsRx only

Principal Display Panel -- 1 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 2 mg Tablet Bottle Label

Pfizer

NDC 0009-0066-07

Xanax XR®
alprazolam
CIV
2 mg
extended-release tablets

60 TabletsRx only

Principal Display Panel -- 2 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 3 mg Tablet Bottle Label

Pfizer

NDC 0009-0068-07

Xanax XR®
alprazolam
CIV
3 mg
extended-release tablets

60 TabletsRx only

Principal Display Panel -- 3 mg Tablet Bottle Label
(click image for full-size original)
XANAX XR alprazolam tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0009-0057
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALPRAZOLAM (ALPRAZOLAM) ALPRAZOLAM 0.5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE
MAGNESIUM STEARATE
SILICON DIOXIDE
HYPROMELLOSES
Product Characteristics
Color WHITE Score no score
Shape PENTAGON (5 SIDED) (pentagon) Size 9mm
Flavor Imprint Code X;0;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0009-0057-07 60 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021434 01/17/2003
XANAX XR alprazolam tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0009-0059
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALPRAZOLAM (ALPRAZOLAM) ALPRAZOLAM 1 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE
MAGNESIUM STEARATE
SILICON DIOXIDE
HYPROMELLOSES
D&C YELLOW NO. 10
Product Characteristics
Color YELLOW Score no score
Shape SQUARE Size 8mm
Flavor Imprint Code X;1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0009-0059-07 60 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021434 01/17/2003
XANAX XR alprazolam tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0009-0066
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALPRAZOLAM (ALPRAZOLAM) ALPRAZOLAM 2 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE
MAGNESIUM STEARATE
SILICON DIOXIDE
HYPROMELLOSES
FD&C BLUE NO. 2
Product Characteristics
Color BLUE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code X;2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0009-0066-07 60 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021434 01/17/2003
XANAX XR alprazolam tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0009-0068
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALPRAZOLAM (ALPRAZOLAM) ALPRAZOLAM 3 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE
MAGNESIUM STEARATE
SILICON DIOXIDE
HYPROMELLOSES
D&C YELLOW NO. 10
FD&C BLUE NO. 2
Product Characteristics
Color GREEN Score no score
Shape TRIANGLE Size 10mm
Flavor Imprint Code X;3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0009-0068-07 60 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021434 01/17/2003
Labeler — Pharmacia and Upjohn Company (829076566)
Establishment
Name Address ID/FEI Operations
Pharmacia and Upjohn Company 829076566 API MANUFACTURE (0009-0068), API MANUFACTURE (0009-0066), API MANUFACTURE (0009-0059), API MANUFACTURE (0009-0057), LABEL (0009-0068), LABEL (0009-0066), LABEL (0009-0059), LABEL (0009-0057), PACK (0009-0068), PACK (0009-0066), PACK (0009-0059), PACK (0009-0057)
Establishment
Name Address ID/FEI Operations
Pfizer Italia S.r.l. 431227388 MANUFACTURE (0009-0068), MANUFACTURE (0009-0066), MANUFACTURE (0009-0059), MANUFACTURE (0009-0057), PACK (0009-0068), PACK (0009-0066), PACK (0009-0059), PACK (0009-0057)
Establishment
Name Address ID/FEI Operations
Pfizer Pharmaceuticals LLC 829084545 ANALYSIS (0009-0068), ANALYSIS (0009-0066), ANALYSIS (0009-0059), ANALYSIS (0009-0057), MANUFACTURE (0009-0068), MANUFACTURE (0009-0066), MANUFACTURE (0009-0059), MANUFACTURE (0009-0057)
Establishment
Name Address ID/FEI Operations
Pfizer Pharmaceuticals LLC 829084552 LABEL (0009-0068), LABEL (0009-0066), LABEL (0009-0059), LABEL (0009-0057), PACK (0009-0068), PACK (0009-0066), PACK (0009-0059), PACK (0009-0057)
Establishment
Name Address ID/FEI Operations
NEOLPHARMA, INC. 078709787 MANUFACTURE (0009-0068), MANUFACTURE (0009-0066), MANUFACTURE (0009-0059), MANUFACTURE (0009-0057)

Revised: 10/2013 Pharmacia and Upjohn Company

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