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NDC 65649-0103-01 APRISO 375 mg/1 Details

APRISO 375 mg/1

APRISO is a ORAL CAPSULE, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Salix Pharmaceuticals, Inc.. The primary component is MESALAMINE.

MedlinePlus Drug Summary

Mesalamine is used to treat ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum) and also to maintain improvement of ulcerative colitis symptoms. Mesalamine is in a class of medications called anti-inflammatory agents. It works by stopping the body from producing a certain substance that may cause inflammation.

Related Packages: 65649-0103-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Mesalamine

Product Information

NDC	65649-0103
Product ID	65649-103_0e88852d-72fc-3002-e063-6394a90a0369
Associated GPIs	52500030007020
GCN Sequence Number	064701
GCN Sequence Number Description	mesalamine CAP ER 24H 0.375G ORAL
HIC3	D6F
HIC3 Description	DRUG TX-CHRONIC INFLAM. COLON DX,5-AMINOSALICYLAT
GCN	16159
HICL Sequence Number	001848
HICL Sequence Number Description	MESALAMINE
Brand/Generic	Brand
Proprietary Name	APRISO
Proprietary Name Suffix	n/a
Non-Proprietary Name	mesalamine
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	CAPSULE, EXTENDED RELEASE
Route	ORAL
Active Ingredient Strength	375
Active Ingredient Units	mg/1
Substance Name	MESALAMINE
Labeler Name	Salix Pharmaceuticals, Inc.
Pharmaceutical Class	Aminosalicylate [EPC], Aminosalicylic Acids [CS]
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA022301
Listing Certified Through	2025-12-31

Package

NDC 65649-0103-01 (65649010301)

Pricing Information	N/A
NDC Package Code	65649-103-01
Billing NDC	65649010301
Package	1 BOTTLE in 1 CARTON (65649-103-01) / 4 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Marketing Start Date	2008-10-31
NDC Exclude Flag	N