NDC Code(s) : 16714-190-01, 16714-191-01, 16714-192-01, 16714-193-01
Packager : NORTHSTAR RXLLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

GuanfacineGuanfacine TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-190
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GUANFACINE HYDROCHLORIDE(UNII: PML56A160O)
(GUANFACINE - UNII:30OMY4G3MK) 		GUANFACINE1 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
FUMARIC ACID(UNII: 88XHZ13131)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
GLYCERYL DIBEHENATE(UNII: R8WTH25YS2)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
Product Characteristics
Color white (white to off white) Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code RJ70
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:16714-190-01100 in 1 BOTTLE Type 0: Not a Combination Product17/09/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205689 09/17/2021
GuanfacineGuanfacine TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-191
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GUANFACINE HYDROCHLORIDE(UNII: PML56A160O)
(GUANFACINE - UNII:30OMY4G3MK) 		GUANFACINE2 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
FUMARIC ACID(UNII: 88XHZ13131)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
GLYCERYL DIBEHENATE(UNII: R8WTH25YS2)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
Product Characteristics
Color white (white to off white) Score no score
Shape OVAL Size 14 mm
Flavor Imprint Code RJ71
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:16714-191-01100 in 1 BOTTLE Type 0: Not a Combination Product17/09/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205689 09/17/2021
GuanfacineGuanfacine TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-192
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GUANFACINE HYDROCHLORIDE(UNII: PML56A160O)
(GUANFACINE - UNII:30OMY4G3MK) 		GUANFACINE3 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
FUMARIC ACID(UNII: 88XHZ13131)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
GLYCERYL DIBEHENATE(UNII: R8WTH25YS2)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
Product Characteristics
Color green Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code RJ72
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:16714-192-01100 in 1 BOTTLE Type 0: Not a Combination Product17/09/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205689 09/17/2021
GuanfacineGuanfacine TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-193
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GUANFACINE HYDROCHLORIDE(UNII: PML56A160O)
(GUANFACINE - UNII:30OMY4G3MK) 		GUANFACINE4 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
FUMARIC ACID(UNII: 88XHZ13131)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
GLYCERYL DIBEHENATE(UNII: R8WTH25YS2)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
Product Characteristics
Color green Score no score
Shape OVAL Size 12 mm
Flavor Imprint Code RJ73
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:16714-193-01100 in 1 BOTTLE Type 0: Not a Combination Product17/09/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205689 09/17/2021

LABELER - NORTHSTAR RXLLC(830546433)

REGISTRANT - SUN PHARMACEUTICAL INDUSTRIES, INC(146974886)

Establishment
Name Address ID/FEI Business Operations
Ohm Laboratories Inc. 184769029 MANUFACTURE(16714-191, 16714-192, 16714-190, 16714-193)

PRINCIPAL DISPLAY PANEL

NDC 16714-190-01

Guanfacine Extended-Release Tablets, USP

1 mg

Tablets should not be crushed, chewed or broken before swallowing.

Rx only

Guanfacine-1 mg