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NDC 63629-8827-01 mesalamine 375 mg/1 Details

mesalamine 375 mg/1

mesalamine is a ORAL CAPSULE, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bryant Ranch Prepack. 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: 63629-8827-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Mesalamine

Product Information

NDC	63629-8827
Product ID	63629-8827_e54103fe-1264-4e91-9be0-4037964ee81a
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	Generic
Proprietary Name	mesalamine
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	Bryant Ranch Prepack
Pharmaceutical Class	Aminosalicylate [EPC], Aminosalicylic Acids [CS]
DEA Schedule	n/a
Marketing Category	NDA AUTHORIZED GENERIC
Application Number	NDA022301
Listing Certified Through	2024-12-31

Package

NDC 63629-8827-01 (63629882701)

Pricing Information	N/A
NDC Package Code	63629-8827-1
Billing NDC	63629882701
Package	120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-8827-1)
Marketing Start Date	2021-09-10
NDC Exclude Flag	N