NDC Code(s) : 60760-432-30
Packager : St Marys Medical Park Pharmacy

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Pantoprazole Sodium Delayed-Release Delayed-Release PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60760-432(NDC:0008-0607)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PANTOPRAZOLE SODIUM(UNII: 6871619Q5X)
(PANTOPRAZOLE - UNII:D8TST4O562) 		PANTOPRAZOLE40 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM STEARATE(UNII: 776XM7047L)
CROSPOVIDONE(UNII: 68401960MK)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
MANNITOL(UNII: 3OWL53L36A)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POVIDONE K25(UNII: K0KQV10C35)
POVIDONE K90(UNII: RDH86HJV5Z)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SODIUM CARBONATE(UNII: 45P3261C7T)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
HYPROMELLOSE 2208 (100 MPA.S)(UNII: B1QE5P712K)
Product Characteristics
Color yellow (YELLOW) Score no score
Shape OVAL (BICONVEX) Size 12 mm
Flavor Imprint Code P;40
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60760-432-3030 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020987 05/23/2014

PRINCIPAL DISPLAY PANEL

PantoprazoleLabel