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NDC 68382-0435-77 mesalamine 800 mg/1 Details

mesalamine 800 mg/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: 68382-0435-77
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Mesalamine

Product Information

NDC	68382-0435
Product ID	68382-435_c2b40002-6c58-4c89-b178-c915a59cb2dd
Associated GPIs	52500030000650
GCN Sequence Number	053882
GCN Sequence Number Description	mesalamine TABLET DR 800 MG ORAL
HIC3	D6F
HIC3 Description	DRUG TX-CHRONIC INFLAM. COLON DX,5-AMINOSALICYLAT
GCN	21663
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	800
Active Ingredient Units	mg/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	ANDA203286
Listing Certified Through	2024-12-31

Package

NDC 68382-0435-77 (68382043577)

Pricing Information	N/A
NDC Package Code	68382-435-77
Billing NDC	68382043577
Package	10 BLISTER PACK in 1 CARTON (68382-435-77) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (68382-435-30)
Marketing Start Date	2018-08-02
NDC Exclude Flag	N