Prescription Drug Information: Pantoprazole Sodium Delayed-release (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70756-019-90

Pantoprazole Sodium Delayed-release Tablets, USP

40 mg

Swallow tablets whole. Do NOT

split, chew, or crush tablets.

PHARMACIST: Dispense the

Medication Guide provided

separately to each patient

Rx only

90 Tablets

NDC 70756-019-12

Pantoprazole Sodium Delayed-release Tablets, USP

40 mg

Swallow tablets whole. Do NOT

split, chew, or crush tablets.

PHARMACIST: Dispense the

Medication Guide provided

separately to each patient

Rx only

1000 Tablets

PANTOPRAZOLE SODIUM DELAYED-RELEASE pantoprazole sodium delayed-release tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70756-019 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 AMMONIA BUTYL ALCOHOL CALCIUM STEARATE CROSPOVIDONE FERRIC OXIDE RED FERROSOFERRIC OXIDE HYPROMELLOSE 2910 (3 MPA.S) ISOPROPYL ALCOHOL MANNITOL METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE SODIUM CARBONATE SUCROSE TALC TRIETHYL CITRATE

Product Characteristics Color BROWN (Light brown to brown) Score no score Shape ROUND Size 8mm Flavor Imprint Code L9 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70756-019-90 90 TABLET in 1 BOTTLE None 2 NDC:70756-019-12 1000 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA215880 07/27/2022

Labeler — Lifestar Pharma LLC (080268943)

Registrant — Mankind Pharma Limited (915834068)

Establishment
Name	Address	ID/FEI	Operations
Mankind Pharma Limited		916512493	MANUFACTURE (70756-019), ANALYSIS (70756-019), PACK (70756-019)

Revised: 09/2023 Lifestar Pharma LLC