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NDC 00037-0022-28 sfRowasa 4 g/60mL Details

sfRowasa 4 g/60mL

sfRowasa 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: 00037-0022-28
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Mesalamine Rectal

Product Information

NDC	00037-0022
Product ID	0037-0022_2a2f46f1-444c-4850-890c-487b36f87716
Associated GPIs	52500030005110
GCN Sequence Number	004444
GCN Sequence Number Description	mesalamine ENEMA 4 G/60 ML RECTAL
HIC3	Q3E
HIC3 Description	CHRONIC INFLAM. COLON DX, 5-A-SALICYLAT,RECTAL TX
GCN	47270
HICL Sequence Number	001848
HICL Sequence Number Description	MESALAMINE
Brand/Generic	Brand
Proprietary Name	sfRowasa
Proprietary Name Suffix	Sulfite-Free Formulation
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 00037-0022-28 (00037002228)

Pricing Information	N/A
NDC Package Code	0037-0022-28
Billing NDC	00037002228
Package	28 BOTTLE, WITH APPLICATOR in 1 CARTON (0037-0022-28) / 60 mL in 1 BOTTLE, WITH APPLICATOR (0037-0022-60)
Marketing Start Date	2016-05-24
NDC Exclude Flag	N