PANTOPRAZOLE SODIUM DELAYED RELEASE tablet, delayed release

Pantoprazole Sodium Delayed Release by

Drug Labeling and Warnings

Pantoprazole Sodium Delayed Release by is a Prescription medication manufactured, distributed, or labeled by Northwind Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

NDC: 51655-500-52

MFG: 0378-6689-10

Pantoprazole Sodium Delayed Release 40 MG

30 Tablets

Rx only

Lot#:

Exp. Date:

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

Pantoprazole is a proton pump inhibitor indicated for the following:

Short-term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD).

Maintenance of Healing of Erosive Esophagitis.

Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome.

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

Adverse Reactions

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

Drug Interactions

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)