MESALAMINE

13 FDA products 11 manufacturers ORAL

MESALAMINE is an active ingredient listed in 13 FDA drug label records from 11 manufacturers taken by oral route marketed mainly as human prescription drug products.

About MESALAMINE

MESALAMINE appears as the active ingredient in 13 FDA drug label records. These products are produced by 11 distinct manufacturers, with the largest catalogues from Zydus Pharmaceuticals USA Inc., ANI Pharmaceuticals, Inc., Alembic Pharmaceuticals Limited. In this ingredient’s product set, the most common route of administration is oral. Approved labelling for these products most frequently references: ulcerative colitis, moderately active, maintenance remission, aminosalicylate indicated, usage mesalamine, delayed-release tablets, treatment mildly, adult patients. Every record below is taken from FDA Structured Product Labelling data; use it to compare brand names, strengths and manufacturers before speaking with a pharmacist.

How it is supplied

Dosage formProductsRouteProducts
— — ORAL 10
— — RECTAL 3
— — — —
— — — —
— — — —
— — — —

Main manufacturers

ManufacturerProductsMarketing type
Zydus Pharmaceuticals USA Inc. 3 HUMAN PRESCRIPTION DRUG
ANI Pharmaceuticals, Inc. 1 HUMAN PRESCRIPTION DRUG
Alembic Pharmaceuticals Limited 1 HUMAN PRESCRIPTION DRUG
Amring Pharmaceuticals Inc. 1 HUMAN PRESCRIPTION DRUG
Major Pharmaceuticals 1 HUMAN PRESCRIPTION DRUG
Mylan Pharmaceuticals Inc. 1 HUMAN PRESCRIPTION DRUG

FDA drug products containing MESALAMINE

Brand nameManufacturerTypeRouteDosage form
MESALAMINE Alembic Pharmaceuticals Limited HUMAN PRESCRIPTION DRUG ORAL
Mesalamine ANI Pharmaceuticals, Inc. HUMAN PRESCRIPTION DRUG RECTAL
Mesalamine Nuvaila Limited HUMAN PRESCRIPTION DRUG ORAL
Mesalamine Sandoz Inc HUMAN PRESCRIPTION DRUG ORAL
Mesalamine Sun Pharmaceutical Industries, Inc. HUMAN PRESCRIPTION DRUG ORAL
Mesalamine Mylan Pharmaceuticals Inc. HUMAN PRESCRIPTION DRUG ORAL
Mesalamine Zydus Pharmaceuticals USA Inc. HUMAN PRESCRIPTION DRUG ORAL
Mesalamine Rectal Amring Pharmaceuticals Inc. HUMAN PRESCRIPTION DRUG RECTAL
Rowasa Viatris Specialty LLC HUMAN PRESCRIPTION DRUG RECTAL
mesalamine Major Pharmaceuticals HUMAN PRESCRIPTION DRUG ORAL
mesalamine Zydus Pharmaceuticals USA Inc. HUMAN PRESCRIPTION DRUG ORAL
mesalamine Zydus Pharmaceuticals USA Inc. HUMAN PRESCRIPTION DRUG ORAL
mesalamine Teva Pharmaceuticals USA, Inc. HUMAN PRESCRIPTION DRUG ORAL

Frequently asked questions

How many FDA drug products contain MESALAMINE?
13 FDA drug label records list MESALAMINE as the active ingredient, supplied by 11 manufacturers. The table below lists the brand names, manufacturers and dosage forms covered by those labels.

Which companies make MESALAMINE products?
The manufacturers with the most MESALAMINE label records are Zydus Pharmaceuticals USA Inc., ANI Pharmaceuticals, Inc., Alembic Pharmaceuticals Limited. Generic and brand versions may be produced by different companies.

Is this a substitute for medical advice?
No. This page reproduces FDA labelling data so you can identify a product and its manufacturer. Dosing, interactions and suitability must be confirmed with a prescriber or pharmacist.

This page reproduces FDA Structured Product Labelling data for identification purposes. It is not medical advice and does not recommend, sell or price any medicine.