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NDC 68382-0711-64 mesalamine 1.2 g/1 Details

mesalamine 1.2 g/1

mesalamine is a ORAL TABLET, DELAYED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Zydus Pharmaceuticals USA 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: 68382-0711-64
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Mesalamine

Product Information

NDC	68382-0711
Product ID	68382-711_d9ce9589-6aee-4dc3-a71b-f1c32ab9f552
Associated GPIs	52500030000670
GCN Sequence Number	062058
GCN Sequence Number Description	mesalamine TABLET DR 1.2 G ORAL
HIC3	D6F
HIC3 Description	DRUG TX-CHRONIC INFLAM. COLON DX,5-AMINOSALICYLAT
GCN	97842
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	TABLET, DELAYED RELEASE
Route	ORAL
Active Ingredient Strength	1.2
Active Ingredient Units	g/1
Substance Name	MESALAMINE
Labeler Name	Zydus Pharmaceuticals USA Inc.
Pharmaceutical Class	Aminosalicylate [EPC], Aminosalicylic Acids [CS]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA091640
Listing Certified Through	2024-12-31

Package

NDC 68382-0711-64 (68382071164)

Pricing Information	N/A
NDC Package Code	68382-711-64
Billing NDC	68382071164
Package	34 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-711-64)
Marketing Start Date	2017-06-19
NDC Exclude Flag	N