Label: PANTOPRAZOLE SODIUM DELAYED RELEASE tablet, delayed release
Contains inactivated NDC Code(s)
NDC Code(s): 51655-500-52
- Packager: Northwind Pharmaceuticals
- This is a repackaged label.
- Source NDC Code(s): 0378-6689
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated June 6, 2014
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PRINCIPAL DISPLAY PANEL
Pantoprazole Sodium Delayed Release 40 MG
Each film-coated tabler contains: pantoprazole sodium, USP equivalent to 40 mg of pantoprazole
Dosage: See package insert
Store at 66-77 degrees F.
Store in a tight, light-resistant container (See USP). Keep out of the reach of children.
Mfg for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA Made in India Lot#:
Repackaged by: Northwind Pharmaceuticals, Indianapolis, IN 46256
- Indications and Usage
Warnings and Precautions
•Symptomatic response does not preclude presence of gastric malignancy.
•Atrophic gastritis has been noted with long-term therapy.
•PPI therapy may be associated with increased risk of Clostridium difficile associated diarrhea.
•Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine.
•Hypomagnesemia has been reported rarely with prolonged treatment with PPIs
The most frequently occurring adverse reactions are as follows:
•For adult use (> 2%) are headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, and arthralgia.
To report SUSPECTED ADVERSE REACTIONS, contact Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
•Do not coadminister with atazanavir or nelfinavir.
•Concomitant warfarin use may require monitoring.
•May interfere with the absorption of drugs where gastric pH is important for bioavailability.
•May produce false-positive urine screen for THC.
•Methotrexate: Pantoprazole may increase serum level of methotrexate
Information describing use in pediatric patients with erosive esophagitis associated with GERD is approved for Wyeth Pharmaceuticals Inc.’s pantoprazole sodium delayed-release tablets. However, due to Wyeth Pharmaceuticals Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
INGREDIENTS AND APPEARANCE
PANTOPRAZOLE SODIUM DELAYED RELEASE
pantoprazole sodium delayed release tablet, delayed release
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51655-500(NDC:0378-6689) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PANTOPRAZOLE SODIUM (UNII: 6871619Q5X) (PANTOPRAZOLE - UNII:D8TST4O562) PANTOPRAZOLE 40 mg Product Characteristics Color yellow Score no score Shape OVAL Size 11mm Flavor Imprint Code M;P9 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51655-500-52 30 in 1 BOTTLE, DISPENSING Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090970 03/21/2014 Labeler - Northwind Pharmaceuticals (036986393) Registrant - Northwind Pharmaceuticals (036986393) Establishment Name Address ID/FEI Business Operations Northwind Pharmaceuticals 036986393 repack(51655-500)