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NDC 00037-0066-03 Rowasa 4 g/60mL Details

Rowasa 4 g/60mL

Rowasa is a RECTAL SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Meda Pharmaceuticals Inc.. The primary component is MESALAMINE.

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: 00037-0066-03
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Mesalamine Rectal

Product Information

NDC	00037-0066
Product ID	0037-0066_28f60c73-ba42-4081-b2d3-c83b3298a92e
Associated GPIs	52500030206420
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	Brand
Proprietary Name	Rowasa
Proprietary Name Suffix	n/a
Non-Proprietary Name	mesalamine
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	SUSPENSION
Route	RECTAL
Active Ingredient Strength	4
Active Ingredient Units	g/60mL
Substance Name	MESALAMINE
Labeler Name	Meda Pharmaceuticals Inc.
Pharmaceutical Class	Aminosalicylate [EPC], Aminosalicylic Acids [CS]
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA019618
Listing Certified Through	2024-12-31

Package

NDC 00037-0066-03 (00037006603)

Pricing Information	N/A
NDC Package Code	0037-0066-03
Billing NDC	00037006603
Package	28 BOTTLE, DISPENSING in 1 CARTON (0037-0066-03) / 60 mL in 1 BOTTLE, DISPENSING (0037-0066-06)
Marketing Start Date	2016-03-24
NDC Exclude Flag	N