PANTOPRAZOLE SODIUM (Page 10 of 10)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pantoprazole Sodium Delayed-Release Tablets, USP 20 mg container Label:

Pantoprazole Sodium Delayed-Release Tablets 20mg
(click image for full-size original)
PANTOPRAZOLE SODIUM pantoprazole tablet, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68788-7798(NDC:31722-712)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PANTOPRAZOLE SODIUM (PANTOPRAZOLE) PANTOPRAZOLE 20 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM STEARATE
FERRIC OXIDE YELLOW
LACTOSE MONOHYDRATE
METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1)
POLYSORBATE 80
PROPYLENE GLYCOL
SODIUM CARBONATE
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
TRIETHYL CITRATE
AMMONIA
FERROSOFERRIC OXIDE
SHELLAC
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
Product Characteristics
Color YELLOW Score no score
Shape OVAL (oval) Size 9mm
Flavor Imprint Code H;125
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-7798-3 30 TABLET, DELAYED RELEASE in 1 BOTTLE None
2 NDC:68788-7798-6 60 TABLET, DELAYED RELEASE in 1 BOTTLE None
3 NDC:68788-7798-9 90 TABLET, DELAYED RELEASE in 1 BOTTLE None
4 NDC:68788-7798-1 100 TABLET, DELAYED RELEASE in 1 BOTTLE None
5 NDC:68788-7798-8 120 TABLET, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202882 09/10/2014
Labeler — Preferred Pharmaceuticals, Inc. (791119022)
Registrant — Preferred Pharmaceuticals, Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals, Inc. 791119022 REPACK (68788-7798)

Revised: 08/2021 Preferred Pharmaceuticals, Inc.

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