NDC Code(s) : 24979-533-01, 24979-533-10, 24979-534-01, 24979-534-10, 24979-536-01, 24979-536-10, 24979-538-01, 24979-538-10
Packager : TWi Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Guanfacine Guanfacine TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24979-533
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GUANFACINE(UNII: 30OMY4G3MK)
(GUANFACINE - UNII:30OMY4G3MK) 		GUANFACINE1 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES(UNII: 3NXW29V3WO)
POLYVINYL ACETATE PHTHALATE(UNII: 58QVG85GW3)
POVIDONE K12(UNII: 333AG72FWJ)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code A533;1;mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24979-533-01100 in 1 BOTTLE Type 0: Not a Combination Product07/07/2017
2NDC:24979-533-101000 in 1 BOTTLE Type 0: Not a Combination Product07/07/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201408 07/07/2017
Guanfacine Guanfacine TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24979-534
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GUANFACINE(UNII: 30OMY4G3MK)
(GUANFACINE - UNII:30OMY4G3MK) 		GUANFACINE2 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES(UNII: 3NXW29V3WO)
POLYVINYL ACETATE PHTHALATE(UNII: 58QVG85GW3)
POVIDONE K12(UNII: 333AG72FWJ)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 12 mm
Flavor Imprint Code A534;2;mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24979-534-01100 in 1 BOTTLE Type 0: Not a Combination Product07/07/2017
2NDC:24979-534-101000 in 1 BOTTLE Type 0: Not a Combination Product07/07/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201408 07/07/2017
Guanfacine Guanfacine TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24979-536
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GUANFACINE(UNII: 30OMY4G3MK)
(GUANFACINE - UNII:30OMY4G3MK) 		GUANFACINE3 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
HYPROMELLOSES(UNII: 3NXW29V3WO)
POLYVINYL ACETATE PHTHALATE(UNII: 58QVG85GW3)
POVIDONE K12(UNII: 333AG72FWJ)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
Product Characteristics
Color BLUE Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code A536;3;mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24979-536-01100 in 1 BOTTLE Type 0: Not a Combination Product07/07/2017
2NDC:24979-536-101000 in 1 BOTTLE Type 0: Not a Combination Product07/07/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201408 07/07/2017
Guanfacine Guanfacine TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24979-538
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GUANFACINE(UNII: 30OMY4G3MK)
(GUANFACINE - UNII:30OMY4G3MK) 		GUANFACINE4 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
HYPROMELLOSES(UNII: 3NXW29V3WO)
POLYVINYL ACETATE PHTHALATE(UNII: 58QVG85GW3)
POVIDONE K12(UNII: 333AG72FWJ)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
Product Characteristics
Color BLUE Score no score
Shape OVAL Size 12 mm
Flavor Imprint Code A538;4;mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24979-538-01100 in 1 BOTTLE Type 0: Not a Combination Product07/07/2017
2NDC:24979-538-101000 in 1 BOTTLE Type 0: Not a Combination Product07/07/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201408 07/07/2017

LABELER - TWi Pharmaceuticals, Inc.(658402052)

Establishment
Name Address ID/FEI Business Operations
TWi Pharmaceuticals, Inc. Zhongli Plant 658863394 ANALYSIS(24979-533, 24979-534, 24979-536, 24979-538), MANUFACTURE(24979-533, 24979-534, 24979-536, 24979-538)

Establishment
Name Address ID/FEI Business Operations
Apace KY, LLC. 361961142 PACK(24979-533, 24979-534, 24979-536, 24979-538)

PRINCIPAL DISPLAY PANEL

NDC 24979-533-01
Guanfacine
Extended-Release Tablets
1 mg
100-count and 1000-count

PRINCIPAL DISPLAY PANEL

NDC 24979-534-01
Guanfacine
Extended-Release Tablets
2 mg
100-count and 1000-count

PRINCIPAL DISPLAY PANEL

NDC 24979-536-01
Guanfacine
Extended-Release Tablets
3 mg
100-count and 1000-count

PRINCIPAL DISPLAY PANEL

NDC 24979-538-01
Guanfacine
Extended-Release Tablets
4 mg
100-count and 1000-count

bottle-label-3-mg.jpg