NDC Code(s) : 63629-1102-1
Packager : Bryant Ranch Prepack

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:63629-1102(NDC:63304-924)
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:63629-1102-1100 in 1 BOTTLE Type 0: Not a Combination Product11/09/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205689 08/17/2018

LABELER - Bryant Ranch Prepack(171714327)

REGISTRANT - Bryant Ranch Prepack(171714327)

Establishment
Name Address ID/FEI Business Operations
Bryant Ranch Prepack 171714327 REPACK(63629-1102), RELABEL(63629-1102)

PRINCIPAL DISPLAY PANEL

GUANFACINE ER 1MG TABLET #100

Label