Pantoprazole Sodium (Page 10 of 10)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 20 mg (90 Tablets Bottle)

NDC 65862-559-90
Rx only
Pantoprazole Sodium
Delayed-Release Tablets, USP
20 mg*
PHARMACIST: Dispense the Medication Guide
provided separately to each patient. AUROBINDO 90 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 20 mg (90 Tablets Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 20 mg Blister Carton (10 x 10 Unit-dose)

NDC 65862-559-10
Rx only
Pantoprazole Sodium
Delayed-Release Tablets, USP
20 mg*
PHARMACIST: Dispense the Medication Guide provided separately to each patient.
AUROBINDO 100 (10 x 10) Unit-dose Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 20 mg Blister Carton (10 x 10 Unit-dose)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 40 mg (90 Tablets Bottle)

NDC 65862-560-90
Rx only
Pantoprazole Sodium
Delayed-Release Tablets, USP
40 mg*
PHARMACIST: Dispense the Medication
Guide provided separately to each patient.
AUROBINDO 90 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 40 mg Blister Carton (10 x 10 Unit-dose)

NDC 65862-560-10
Rx only
Pantoprazole Sodium
Delayed-Release Tablets, USP
40 mg*
PHARMACIST: Dispense the Medication Guide provided separately to each patient. AUROBINDO 100 (10 x 10) Unit-dose Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PANTOPRAZOLE SODIUM pantoprazole sodium tablet, delayed release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67296-1812(NDC:65862-560) 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 (15 MPA.S AT 5%) FERRIC OXIDE YELLOW HYDROXYPROPYL CELLULOSE (90000 WAMW) HYPROMELLOSE 2910 (3 MPA.S) MANNITOL METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A SODIUM CARBONATE TRIETHYL CITRATE AMMONIA FERROSOFERRIC OXIDE FERRIC OXIDE RED ISOPROPYL ALCOHOL BUTYL ALCOHOL PROPYLENE GLYCOL SHELLAC

Product Characteristics Color yellow Score no score Shape OVAL (Biconvex) Size 12mm Flavor Imprint Code I;52 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:67296-1812-7 14 TABLET, DELAYED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202038 09/28/2012

Labeler — RedPharm Drug (828374897)

Establishment
Name	Address	ID/FEI	Operations
EPM Packaging		079124340	repack (67296-1812)

Revised: 01/2022 RedPharm Drug