NDC Code(s) : 61786-064-02
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Quetiapine fumaratequetiapine fumarate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61786-064(NDC:68180-447)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUETIAPINE FUMARATE(UNII: 2S3PL1B6UJ)
(QUETIAPINE - UNII:BGL0JSY5SI) 		QUETIAPINE100 mg
Inactive Ingredients
Ingredient Name Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(UNII: O7TSZ97GEP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
POVIDONE K30(UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color yellow (Yellow) Score no score
Shape ROUND (Round) Size 9 mm
Flavor Imprint Code LU;Y17
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61786-064-0230 in 1 BLISTER PACK Type 0: Not a Combination Product13/10/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201109 10/13/2014

PRINCIPAL DISPLAY PANEL

DRUG: Quetiapine fumarate

GENERIC: quetiapine fumarate

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 61786-064-02

COLOR: yellow

SHAPE: ROUND

SCORE: No score

SIZE: 9 mm

IMPRINT: LU;Y17

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • QUETIAPINE FUMARATE 100mg in 1

INACTIVE INGREDIENT(S):

  • CELLULOSE, MICROCRYSTALLINE
  • DIBASIC CALCIUM PHOSPHATE DIHYDRATE
  • LACTOSE MONOHYDRATE
  • MAGNESIUM STEARATE
  • POLYETHYLENE GLYCOL 400
  • FERRIC OXIDE YELLOW
  • HYPROMELLOSE 2910 (6 MPA.S)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO
  • POVIDONE K30
  • TITANIUM DIOXIDE

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