Guanfacine (Page 7 of 7)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Generic Section

NDC 63304-924-01

Guanfacine Extended-Release Tablets, USP

1 mg

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

Rx only

100 Tablets OHM

Generic Section

NDC 63304-925-01

Guanfacine Extended-Release Tablets, USP

2 mg

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

Rx only

100 Tablets OHM

Generic Section

NDC 63304-926-01

Guanfacine Extended-Release Tablets, USP

3 mg

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

Rx only

100 Tablets OHM

Generic Section

NDC 63304-927-01

Guanfacine Extended-Release Tablets, USP

4 mg

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

Rx only

100 Tablets OHM

GUANFACINE guanfacine tablet, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-924 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUANFACINE HYDROCHLORIDE (GUANFACINE) GUANFACINE 1 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE FUMARIC ACID METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A GLYCERYL DIBEHENATE SILICON DIOXIDE MICROCRYSTALLINE CELLULOSE HYPROMELLOSE, UNSPECIFIED POVIDONE, UNSPECIFIED

Product Characteristics Color white (white to off white) Score no score Shape ROUND Size 8mm Flavor Imprint Code RJ70 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:63304-924-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None 2 NDC:63304-924-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None 3 NDC:63304-924-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA205689 08/17/2018

GUANFACINE guanfacine tablet, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-925 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUANFACINE HYDROCHLORIDE (GUANFACINE) GUANFACINE 2 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE FUMARIC ACID METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A GLYCERYL DIBEHENATE SILICON DIOXIDE MICROCRYSTALLINE CELLULOSE HYPROMELLOSE, UNSPECIFIED POVIDONE, UNSPECIFIED

Product Characteristics Color white (white to off white) Score no score Shape OVAL Size 14mm Flavor Imprint Code RJ71 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:63304-925-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None 2 NDC:63304-925-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None 3 NDC:63304-925-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA205689 08/17/2018

GUANFACINE guanfacine tablet, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-926 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUANFACINE HYDROCHLORIDE (GUANFACINE) GUANFACINE 3 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE FUMARIC ACID METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A FD&C BLUE NO. 2 FERRIC OXIDE YELLOW SILICON DIOXIDE GLYCERYL DIBEHENATE MICROCRYSTALLINE CELLULOSE HYPROMELLOSE, UNSPECIFIED POVIDONE, UNSPECIFIED

Product Characteristics Color green Score no score Shape ROUND Size 8mm Flavor Imprint Code RJ72 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:63304-926-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None 2 NDC:63304-926-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None 3 NDC:63304-926-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA205689 08/17/2018

GUANFACINE guanfacine tablet, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-927 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUANFACINE HYDROCHLORIDE (GUANFACINE) GUANFACINE 4 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE FUMARIC ACID METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A FD&C BLUE NO. 2 FERRIC OXIDE YELLOW GLYCERYL DIBEHENATE SILICON DIOXIDE MICROCRYSTALLINE CELLULOSE HYPROMELLOSE, UNSPECIFIED POVIDONE, UNSPECIFIED

Product Characteristics Color green Score no score Shape OVAL Size 12mm Flavor Imprint Code RJ73 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:63304-927-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None 2 NDC:63304-927-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None 3 NDC:63304-927-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA205689 08/17/2018

Labeler — Sun Pharmaceutical Industries, Inc (146974886)

Registrant — Sun Pharmaceutical Industries, Inc (146974886)

Establishment
Name	Address	ID/FEI	Operations
Ohm Laboratories Inc.		184769029	MANUFACTURE (63304-924), MANUFACTURE (63304-925), MANUFACTURE (63304-926), MANUFACTURE (63304-927)

Establishment
Name	Address	ID/FEI	Operations
Medichem S.A.		464043381	API MANUFACTURE (63304-924), API MANUFACTURE (63304-925), API MANUFACTURE (63304-926), API MANUFACTURE (63304-927)

Revised: 09/2021 Sun Pharmaceutical Industries, Inc