Guanfacine Extended-Release (Page 7 of 7)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 60429-960-01
Guanfacine
Extended-Release Tablets
1 mg
100-count

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Package/Label Display Panel

NDC 60429-961-0
Guanfacine
Extended-Release Tablets
2 mg 100-count

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Package/Label Display Panel

NDC 60429-962-01
Guanfacine
Extended-Release Tablets
3 mg 100-count

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Package/Label Display Panel

NDC 60429-963-01
Guanfacine
Extended-Release Tablets
4 mg 100-count

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GUANFACINE EXTENDED-RELEASE guanfacine tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-960(NDC:24979-533)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GUANFACINE (GUANFACINE) GUANFACINE 1 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
POLYVINYL ACETATE PHTHALATE
POVIDONE K12
SODIUM LAURYL SULFATE
SILICON DIOXIDE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color white Score no score
Shape ROUND Size 8mm
Flavor Imprint Code A533;1;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60429-960-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201408 06/02/2015
GUANFACINE EXTENDED-RELEASE guanfacine tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-961(NDC:24979-534)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GUANFACINE (GUANFACINE) GUANFACINE 2 mg
Inactive Ingredients
Ingredient Name Strength
POLYVINYL ACETATE PHTHALATE
POVIDONE K12
SODIUM LAURYL SULFATE
SILICON DIOXIDE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
HYPROMELLOSES
Product Characteristics
Color white Score no score
Shape OVAL Size 12mm
Flavor Imprint Code A534;2;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60429-961-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201408 06/02/2015
GUANFACINE EXTENDED-RELEASE guanfacine tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-962(NDC:24979-536)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GUANFACINE (GUANFACINE) GUANFACINE 3 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1
HYPROMELLOSES
POLYVINYL ACETATE PHTHALATE
POVIDONE K12
SODIUM LAURYL SULFATE
SILICON DIOXIDE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color blue Score no score
Shape ROUND Size 8mm
Flavor Imprint Code A536;3;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60429-962-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201408 06/02/2015
GUANFACINE EXTENDED-RELEASE guanfacine tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-963(NDC:24979-538)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GUANFACINE (GUANFACINE) GUANFACINE 4 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1
HYPROMELLOSES
POLYVINYL ACETATE PHTHALATE
POVIDONE K12
SODIUM LAURYL SULFATE
SILICON DIOXIDE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color blue Score no score
Shape OVAL Size 12mm
Flavor Imprint Code A538;4;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60429-963-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201408 06/02/2015
Labeler — Golden State Medical Supply, Inc. (603184490)
Establishment
Name Address ID/FEI Operations
Golden State Medical Supply, Inc. 603184490 relabel (60429-960), repack (60429-960), relabel (60429-961), repack (60429-961), relabel (60429-962), repack (60429-962), relabel (60429-963), repack (60429-963)

Revised: 12/2019 Golden State Medical Supply, Inc.

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