Prescription Drug Information: Pantoprazole (Page 7 of 7)

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 pantoprazole tablet, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68788-8505(NDC:55111-332)
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
AMMONIA
CALCIUM STEARATE
Crospovidone
Hydroxypropyl Cellulose, Unspecified
HYPROMELLOSE, UNSPECIFIED
FERROSOFERRIC OXIDE
ISOPROPYL ALCOHOL
MANNITOL
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
BUTYL ALCOHOL
POLYETHYLENE GLYCOL 400
PROPYLENE GLYCOL
SHELLAC
SODIUM CARBONATE
FERRIC OXIDE YELLOW
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
ZEIN
ALCOHOL
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 6mm
Flavor Imprint Code R332
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-8505-3 30 TABLET, DELAYED RELEASE in 1 BOTTLE None
2 NDC:68788-8505-6 60 TABLET, DELAYED RELEASE in 1 BOTTLE None
3 NDC:68788-8505-9 90 TABLET, DELAYED RELEASE in 1 BOTTLE None
4 NDC:68788-8505-1 100 TABLET, DELAYED RELEASE in 1 BOTTLE None
5 NDC:68788-8505-8 120 TABLET, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077619 08/15/2023
Labeler — Preferred Pharmaceuticals Inc. (791119022)
Registrant — Preferred Pharmaceuticals Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals Inc. 791119022 REPACK (68788-8505)

Revised: 08/2023 Preferred Pharmaceuticals Inc.

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