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NDC 63629-2397-01 Mesalamine 1000 mg/1 Details

Mesalamine 1000 mg/1

Mesalamine is a RECTAL SUPPOSITORY in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is MESALAMINE.

MedlinePlus Drug Summary

Rectal mesalamine is used to treat ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum), proctitis (swelling in the rectum), and proctosigmoiditis (swelling in the rectum and sigmoid colon [last section of the colon]). Rectal 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: 63629-2397-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Mesalamine Rectal

Product Information

NDC	63629-2397
Product ID	63629-2397_4b660c77-a50b-4a0e-8264-d8569cdc82d9
Associated GPIs	52500030005240
GCN Sequence Number	021776
GCN Sequence Number Description	mesalamine SUPP.RECT 1000 MG RECTAL
HIC3	Q3E
HIC3 Description	CHRONIC INFLAM. COLON DX, 5-A-SALICYLAT,RECTAL TX
GCN	48490
HICL Sequence Number	001848
HICL Sequence Number Description	MESALAMINE
Brand/Generic	Generic
Proprietary Name	Mesalamine
Proprietary Name Suffix	n/a
Non-Proprietary Name	Mesalamine
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	SUPPOSITORY
Route	RECTAL
Active Ingredient Strength	1000
Active Ingredient Units	mg/1
Substance Name	MESALAMINE
Labeler Name	Bryant Ranch Prepack
Pharmaceutical Class	Aminosalicylate [EPC], Aminosalicylic Acids [CS]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA207448
Listing Certified Through	2024-12-31

Package

NDC 63629-2397-01 (63629239701)

Pricing Information	N/A
NDC Package Code	63629-2397-1
Billing NDC	63629239701
Package	5 PACKAGE in 1 CARTON (63629-2397-1) / 6 SUPPOSITORY in 1 PACKAGE
Marketing Start Date	2021-05-04
NDC Exclude Flag	N