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NDC 67877-0717-05 Mesalamine 0.375 g/1 Details

Mesalamine 0.375 g/1

Mesalamine is a ORAL CAPSULE, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Ascend Laboratories, LLC. 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: 67877-0717-05
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Mesalamine

Product Information

NDC	67877-0717
Product ID	67877-717_f477e4bf-c750-40b1-9a8b-6af4bbaacfc4
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	0.375
Active Ingredient Units	g/1
Substance Name	MESALAMINE
Labeler Name	Ascend Laboratories, LLC
Pharmaceutical Class	Aminosalicylate [EPC], Aminosalicylic Acids [CS]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA214242
Listing Certified Through	2024-12-31

Package

NDC 67877-0717-05 (67877071705)

Pricing Information	N/A
NDC Package Code	67877-717-05
Billing NDC	67877071705
Package	500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (67877-717-05)
Marketing Start Date	2021-07-16
NDC Exclude Flag	N