NDC Code(s) : 50090-1100-0, 50090-1100-1
Packager : A-S Medication Solutions

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Pantoprazole SodiumPantoprazole Sodium TABLET, DELAYED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-1100(NDC:13668-429)
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 (15 MPA.S AT 5%)(UNII: 68401960MK)
HYDROXYPROPYL CELLULOSE (1200000 MW)(UNII: RFW2ET671P)
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
MANNITOL(UNII: 3OWL53L36A)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SODIUM CARBONATE DECAHYDRATE(UNII: LS505BG22I)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
Product Characteristics
Color WHITE (white to pale yellow) Score no score
Shape OVAL (oval shaped, biconvex) Size 11 mm
Flavor Imprint Code 97
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50090-1100-0 30 in 1 BOTTLE Type 0: Not a Combination Product28/11/2014
2NDC:50090-1100-1 90 in 1 BOTTLE Type 0: Not a Combination Product28/11/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090074 01/20/2011 07/31/2017

PRINCIPAL DISPLAY PANEL

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