Fluphenazine hydrochloride tablet, film coated

Ingredients and appearance - Product information

Fluphenazine hydrochloride tablet, film coated- Fluphenazine hydrochloride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 61786-803
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Fluphenazine hydrochloride ( UNII: ZOU145W1XL)( Fluphenazine - UNII: S79426A41Z ) 5 mgin 1

Inactive Ingredients

Ingredient Name Code
Starch, corn ( UNII: O8232NY3SJ)
Calcium phosphate, dibasic, dihydrate ( UNII: O7TSZ97GEP)
Hypromelloses ( UNII: 3NXW29V3WO)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Polyethylene glycols ( UNII: 3WJQ0SDW1A)
Polysorbate 80 ( UNII: 6OZP39ZG8H)
Water ( UNII: 059QF0KO0R)
Titanium dioxide ( UNII: 15FIX9V2JP)
D&c red no. 27 ( UNII: 2LRS185U6K)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
D&c red no. 30 ( UNII: 2S42T2808B)
D&c yellow no. 10 ( UNII: 35SW5USQ3G)

Product Characteristics

Color pink (Dark pink) Imprint Code LCI;1790
Score 1 Shape ROUND
Size 8 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 61786-803-02 30 in 1 BLISTER PACK 2016/08/03

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA089742 USA 2016/08/03

Labeler - REMEDYREPACK INC.( 829572556)

Package label.principal display panel

DRUG: Fluphenazine Hydrochloride

GENERIC: Fluphenazine Hydrochloride

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 61786-803-02

COLOR: pink

SHAPE: ROUND

SCORE: No score

SIZE: 8 mm

IMPRINT: LCI;1790

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • FLUPHENAZINE HYDROCHLORIDE 5mg in 1

INACTIVE INGREDIENT(S):

  • D&C RED NO. 27
  • D&C YELLOW NO. 10
  • TITANIUM DIOXIDE
  • D&C RED NO. 30
  • FD&C BLUE NO. 1
  • WATER
  • POLYSORBATE 80
  • CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
  • HYPROMELLOSES
  • LACTOSE MONOHYDRATE
  • MAGNESIUM STEARATE
  • POLYETHYLENE GLYCOLS
  • STARCH, CORN