NDC Code(s) : 0186-0510-60, 0186-0520-06, 0186-0520-60, 0186-0520-39
Packager : AstraZeneca LP

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

VIMOVOnaproxen and esomeprazole magnesium TABLET, DELAYED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0186-0510
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPROXEN(UNII: 57Y76R9ATQ)
(NAPROXEN - UNII:57Y76R9ATQ) 		NAPROXEN375 mg
ESOMEPRAZOLE MAGNESIUM(UNII: R6DXU4WAY9)
(ESOMEPRAZOLE - UNII:N3PA6559FT) 		ESOMEPRAZOLE20 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX(UNII: R12CBM0EIZ)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHACRYLIC ACID(UNII: 1CS02G8656)
METHYLPARABEN(UNII: A2I8C7HI9T)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
POVIDONE(UNII: FZ989GH94E)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POLYDEXTROSE(UNII: VH2XOU12IE)
Product Characteristics
Color YELLOW (film-coated) Score no score
Shape OVAL Size 17 mm
Flavor Imprint Code 375;20
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0186-0510-6060 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022511 07/06/2010
VIMOVOnaproxen and esomeprazole magnesium TABLET, DELAYED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0186-0520
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPROXEN(UNII: 57Y76R9ATQ)
(NAPROXEN - UNII:57Y76R9ATQ) 		NAPROXEN500 mg
ESOMEPRAZOLE MAGNESIUM(UNII: R6DXU4WAY9)
(ESOMEPRAZOLE - UNII:N3PA6559FT) 		ESOMEPRAZOLE20 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX(UNII: R12CBM0EIZ)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHACRYLIC ACID(UNII: 1CS02G8656)
METHYLPARABEN(UNII: A2I8C7HI9T)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
POVIDONE(UNII: FZ989GH94E)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POLYDEXTROSE(UNII: VH2XOU12IE)
Product Characteristics
Color YELLOW (film-coated) Score no score
Shape OVAL Size 18 mm
Flavor Imprint Code 500;20
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0186-0520-066 in 1 BOTTLE
2NDC:0186-0520-6060 in 1 BOTTLE
3NDC:0186-0520-3910 in 1 CARTON
310 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022511 07/06/2010

PRINCIPAL DISPLAY PANEL

NDC 0186-0510-60

60 tablets

VIMOVO®

(naproxen and esomeprazole magnesium)

Delayed release tablets

375 mg/20 mg*

*Each tablet contains 22.3 mg esomeprazole magnesium,

Equivalent to 20 mg of esomeprazole.

Dispense the enclosed Medication Guide to each patient.

Rx only

AstraZeneca

VIMOVO 375MG/20MG - 60 Count Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 0186-0520-60

60 tablets

VIMOVO®

(naproxen and esomeprazole magnesium)

Delayed release tablets

500 mg/20 mg*

*Each tablet contains 22.3 mg esomeprazole magnesium,

Equivalent to 20 mg of esomeprazole.

Dispense the enclosed Medication Guide to each patient.

Rx only

AstraZeneca

VIMOVO 500 mg/20mg - 60 Count Bottle Label