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NDC 63629-8679-01 Mesalamine Details

Mesalamine

Mesalamine is a KIT in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is .

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: 63629-8679-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Mesalamine Rectal

Product Information

NDC	63629-8679
Product ID	63629-8679_00c5cbe7-c0e5-9145-e063-6394a90af411
Associated GPIs
GCN Sequence Number	064139
GCN Sequence Number Description	mesalamine w/cleansing wipes ENEMA KIT 4 G/60 ML RECTAL
HIC3	Q3E
HIC3 Description	CHRONIC INFLAM. COLON DX, 5-A-SALICYLAT,RECTAL TX
GCN	99847
HICL Sequence Number	035675
HICL Sequence Number Description	MESALAMINE WITH CLEANSING WIPES
Brand/Generic	Generic
Proprietary Name	Mesalamine
Proprietary Name Suffix	n/a
Non-Proprietary Name	Mesalamine
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	KIT
Route	n/a
Active Ingredient Strength	n/a
Active Ingredient Units	n/a
Substance Name	n/a
Labeler Name	Bryant Ranch Prepack
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA076751
Listing Certified Through	2024-12-31

Package

NDC 63629-8679-01 (63629867901)

Pricing Information	N/A
NDC Package Code	63629-8679-1
Billing NDC	63629867901
Package	4 CARTON in 1 KIT (63629-8679-1) / 1 KIT in 1 CARTON * 60 mL in 1 BOTTLE (45802-098-46) * 1 SWAB in 1 PACKET
Marketing Start Date	2018-08-02
NDC Exclude Flag	N