PANTOPRAZOLE SODIUM (Page 10 of 10)

PRINCIPAL DISPLAY PANEL

NDC: 42708-104-30

Label
(click image for full-size original)
PANTOPRAZOLE SODIUM pantoprazole tablet, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42708-104(NDC:31722-713)
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
FERRIC OXIDE YELLOW
HYPROMELLOSES
LACTOSE MONOHYDRATE
METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1)
POLYSORBATE 80
PROPYLENE GLYCOL
SODIUM CARBONATE
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
TRIETHYL CITRATE
AMMONIA
FERROSOFERRIC OXIDE
SHELLAC
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
CARNAUBA WAX
Product Characteristics
Color yellow Score no score
Shape OVAL Size 12mm
Flavor Imprint Code H;126
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42708-104-30 30 TABLET, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202882 09/10/2014
Labeler — QPharma Inc (030620888)
Registrant — Camber Pharmaceuticals, Inc. (826774775)
Establishment
Name Address ID/FEI Operations
Northwind Pharmaceuticals, LLC 036986393 repack (42708-104)

Revised: 08/2023 QPharma Inc

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