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NDC 31722-0005-31 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 Camber Pharmaceuticals, Inc.. 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: 31722-0005-31
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Mesalamine Rectal

Product Information

NDC	31722-0005
Product ID	31722-005_ef4dbb3d-1d1f-0b62-e053-2995a90a921c
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	Camber Pharmaceuticals, Inc.
Pharmaceutical Class	Aminosalicylate [EPC], Aminosalicylic Acids [CS]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA213377
Listing Certified Through	2024-12-31

Package

NDC 31722-0005-31 (31722000531)

Pricing Information	N/A
NDC Package Code	31722-005-31
Billing NDC	31722000531
Package	7 PACKAGE in 1 CARTON (31722-005-31) / 6 SUPPOSITORY in 1 PACKAGE (31722-005-32)
Marketing Start Date	2020-03-19
NDC Exclude Flag	N