Guanfacine tablet, extended release

Ingredients and appearance - Product information

Guanfacine tablet, extended release- Guanfacine

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 69189-2850
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Guanfacine hydrochloride ( UNII: PML56A160O)( Guanfacine - UNII: 30OMY4G3MK ) 1 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Crospovidone ( UNII: 2S7830E561)
Fumaric acid ( UNII: 88XHZ13131)
Glyceryl behenate/eicosadioate ( UNII: 73CJJ317SR)
Hydroxypropyl cellulose (700000 mw) ( UNII: U3JF91U133)
Hypromelloses ( UNII: 3NXW29V3WO)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Povidone ( UNII: FZ989GH94E)
Fd&c yellow no. 6 ( UNII: H77VEI93A8)

Product Characteristics

Color orange Imprint Code 850
Score 1 Shape ROUND
Size 9 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 69189-2850-1 1 DOSE PACK 2015/04/21

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA200881 USA 2015/04/21

Labeler - Avera McKennan Hospital( 068647668)

Establishment

Name ID/FEI Business Operations
Avera McKennan Hospital 068647668 relabel( 69189-2850), repack( 69189-2850)