NDC Code(s) : 68084-837-11, 68084-837-21, 68084-837-95, 68084-837-25
Packager : American Health Packaging

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Fluvoxamine MaleateFluvoxamine Maleate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-837(NDC:60505-0165)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUVOXAMINE MALEATE(UNII: 5LGN83G74V)
(FLUVOXAMINE - UNII:O4L1XPO44W) 		FLUVOXAMINE MALEATE50 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)(UNII: 8136Y38GY5)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
POLYETHYLENE GLYCOL 8000(UNII: Q662QK8M3B)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color yellow Score 2 pieces
Shape ROUND Size 9 mm
Flavor Imprint Code APO;F50
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68084-837-2130 in 1 BOX, UNIT-DOSE 29/09/2014
1NDC:68084-837-111 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:68084-837-2530 in 1 BOX, UNIT-DOSE 01/02/2016
2NDC:68084-837-951 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075902 09/29/2014 10/31/2017

PRINCIPAL DISPLAY PANEL

50 mg Fluvoxamine Maleate Tablets Carton

NDC 68084-837-25

Fluvoxamine Maleate
Tablets, USP

50 mg

30 Tablets (5 × 6)

PHARMACIST: Dispense with the accompanying
Medication Guide to each patient.

Each Tablet Contains:
Fluvoxamine maleate .........................................50 mg.

Usual dosage: See package insert for full
prescribing information.

Store at 20º to 25ºC (68º to 77ºF); excursions
permitted to 15º to 30ºC (59º to 86ºF) [see
USP Controlled Room Temperature]. Protect from
high humidity.

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is
torn or broken.

Rx Only

The drug product contained in this package is from
NDC # 60505-0165, Apotex Corp.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

083725
0283725/1015OS

PRINCIPAL DISPLAY PANEL

50 mg Fluvoxamine Maleate Tablet Blister.jpg

Fluvoxamine
Maleate
Tablet, USP

50 mg