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

40-90
(click image for full-size original)

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

40-1000
(click image for full-size original)
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: 08/2022 Lifestar Pharma LLC

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