Pantoprazole Sodium (Page 9 of 9)

PACKAGE LABEL

Label Image for 53808-0935
20mg

Label Image for 20mgLabel Image for 20mg

PACKAGE LABEL

Label Image for 53808-1058 40mg

Label Image for 40mgLabel Image for 40mg
PANTOPRAZOLE SODIUM pantoprazole sodium tablet, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53808-0935(NDC:13668-096)
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
CROSPOVIDONE
HYDROXYPROPYL CELLULOSE (TYPE H)
HYPROMELLOSE 2910 (3 MPA.S)
MANNITOL
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
PROPYLENE GLYCOL
SODIUM CARBONATE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color WHITE (white to pale yellow) Score no score
Shape OVAL (oval shaped, biconvex) Size 9mm
Flavor Imprint Code 96
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53808-0935-1 30 TABLET, DELAYED RELEASE (TABLET) in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090074 01/01/2014
PANTOPRAZOLE SODIUM pantoprazole sodium tablet, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53808-1058(NDC:13668-429)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PANTOPRAZOLE SODIUM (PANTOPRAZOLE) PANTOPRAZOLE 40 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM STEARATE
CROSPOVIDONE
HYDROXYPROPYL CELLULOSE (TYPE H)
HYPROMELLOSE 2910 (3 MPA.S)
MANNITOL
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
PROPYLENE GLYCOL
SODIUM CARBONATE DECAHYDRATE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color WHITE (white to pale yellow) Score no score
Shape OVAL (oval shaped, biconvex) Size 11mm
Flavor Imprint Code 97
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53808-1058-1 30 TABLET, DELAYED RELEASE (TABLET) in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090074 11/01/2014
Labeler — State of Florida DOH Central Pharmacy (829348114)
Establishment
Name Address ID/FEI Operations
State of Florida DOH Central Pharmacy 829348114 repack (53808-0935), repack (53808-1058)

Revised: 01/2015 State of Florida DOH Central Pharmacy

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