NDC Code(s) : 58118-5040-3
Packager : Clinical Solutions Wholesale

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

NEXIUMEsomeprazole magnesium CAPSULE, DELAYED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58118-5040(NDC:0186-5040)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESOMEPRAZOLE MAGNESIUM(UNII: R6DXU4WAY9)
(ESOMEPRAZOLE - UNII:N3PA6559FT) 		ESOMEPRAZOLE40 mg
Inactive Ingredients
Ingredient Name Strength
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHACRYLIC ACID(UNII: 1CS02G8656)
TALC(UNII: 7SEV7J4R1U)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
GELATIN(UNII: 2G86QN327L)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 40(UNII: WZB9127XOA)
D&C RED NO. 28(UNII: 767IP0Y5NH)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
ALCOHOL(UNII: 3K9958V90M)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
POVIDONES(UNII: FZ989GH94E)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
Product Characteristics
Color purple (Amethyst) Score no score
Shape CAPSULE Size 14 mm
Flavor Imprint Code NEXIUM40mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58118-5040-330 in 1 BOTTLE Type 0: Not a Combination Product19/10/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021153 03/19/2001 06/22/2017

PRINCIPAL DISPLAY PANEL

Nexium 40 Lab 3