NDC Code(s) : 68453-375-10, 68453-850-75, 68453-777-03, 68453-900-02
Packager : Victory Pharma, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

NAPRELANnaproxen sodium TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68453-375
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
naproxen sodium(UNII: 9TN87S3A3C)
(naproxen - UNII:57Y76R9ATQ) 		naproxen sodium375 mg
Inactive Ingredients
Ingredient Name Strength
anhydrous citric acid(UNII: XF417D3PSL)
crospovidone (15 mpa.s at 5%)(UNII: 68401960MK)
magnesium stearate(UNII: 70097M6I30)
microcrystalline cellulose(UNII: OP1R32D61U)
povidone, unspecified(UNII: FZ989GH94E)
talc(UNII: 7SEV7J4R1U)
hypromellose, unspecified(UNII: 3NXW29V3WO)
polyethylene glycol, unspecified(UNII: 3WJQ0SDW1A)
titanium dioxide(UNII: 15FIX9V2JP)
Product Characteristics
Color white (white) Score no score
Shape CAPSULE (CAPSULE) Size 15 mm
Flavor Imprint Code N;375
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68453-375-10100 in 1 BOTTLE Type 0: Not a Combination Product05/01/1996
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020353 01/05/1996 10/31/2013
NAPRELANnaproxen sodium TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68453-850
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
naproxen sodium(UNII: 9TN87S3A3C)
(naproxen - UNII:57Y76R9ATQ) 		naproxen sodium500 mg
Inactive Ingredients
Ingredient Name Strength
anhydrous citric acid(UNII: XF417D3PSL)
crospovidone (15 mpa.s at 5%)(UNII: 68401960MK)
magnesium stearate(UNII: 70097M6I30)
microcrystalline cellulose(UNII: OP1R32D61U)
povidone, unspecified(UNII: FZ989GH94E)
talc(UNII: 7SEV7J4R1U)
hypromellose, unspecified(UNII: 3NXW29V3WO)
polyethylene glycol, unspecified(UNII: 3WJQ0SDW1A)
titanium dioxide(UNII: 15FIX9V2JP)
Product Characteristics
Color white (white) Score no score
Shape CAPSULE (CAPSULE) Size 17 mm
Flavor Imprint Code N;500
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68453-850-7575 in 1 BOTTLE Type 0: Not a Combination Product05/01/1996
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020353 01/05/1996 10/31/2013
NAPRELANnaproxen sodium TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68453-777
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
naproxen sodium(UNII: 9TN87S3A3C)
(naproxen - UNII:57Y76R9ATQ) 		naproxen sodium750 mg
Inactive Ingredients
Ingredient Name Strength
anhydrous citric acid(UNII: XF417D3PSL)
crospovidone (15 mpa.s at 5%)(UNII: 68401960MK)
magnesium stearate(UNII: 70097M6I30)
microcrystalline cellulose(UNII: OP1R32D61U)
povidone, unspecified(UNII: FZ989GH94E)
talc(UNII: 7SEV7J4R1U)
hypromellose, unspecified(UNII: 3NXW29V3WO)
polyethylene glycol, unspecified(UNII: 3WJQ0SDW1A)
titanium dioxide(UNII: 15FIX9V2JP)
Product Characteristics
Color white (white) Score no score
Shape CAPSULE (CAPSULE) Size 22 mm
Flavor Imprint Code N;750
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68453-777-0330 in 1 BOTTLE Type 0: Not a Combination Product19/12/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020353 12/19/2008 10/31/2013
NAPRELANnaproxen sodium KIT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68453-900
Route of Administration ORAL DEA Schedule
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68453-900-021 in 1 DOSE PACK Type 0: Not a Combination Product15/10/2009
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020353 10/15/2009 10/31/2013

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 375 MG BOTTLE

NDC 68453-375-10

NAPRELAN ®

(naproxen sodium)

CONTROLLED-RELEASE TABLETS

375 mg

Each tablet contains 412.5 mg naproxen sodium

equivalent to 375 mg naproxen

Rx only

100 Tablets

Victory Pharma

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 375 MG BOTTLE

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 500 MG BOTTLE

NDC 68453-850-75

NAPRELAN ®

(naproxen sodium)

CONTROLLED-RELEASE TABLETS

500 mg

Each tablet contains 550 mg naproxen sodium

equivalent to 500 mg naproxen

Rx only

75 Tablets

Victory Pharma

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 500 MG BOTTLE

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 750 MG BOTTLE

NDC 68453-777-03

NAPRELAN ®

(naproxen sodium)

CONTROLLED-RELEASE TABLETS

750 mg

Each tablet contains 825 mg naproxen sodium

equivalent to 750 mg naproxen

Rx only

30 Tablets

Victory Pharma

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 750 MG BOTTLE

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – DOSE CARD

NDC 68453-900-02

NAPRELAN ®

(naproxen sodium)

500 mg and 750 mg Controlled-Release Tablets

Utilizing the IPDAS® Biphasic System

Dose Card

Rx only

Full Prescribing Information

Including Medication Guide Enclosed

Victory Pharma

Keep out of reach of children

Store at controlled

room temperature,

20°-25° C (68°-77°F).

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – DOSE CARD