This site is intended for healthcare professionals
FDA Hero  Banner - Multi-coloured pills and tablets
FDA Drug information

Indomethacin

Read time: 1 mins
Marketing start date: 28 May 2024

Summary of product characteristics


Effective Time

20231004

Version

5

Spl Product Data Elements

indomethacin indomethacin INDOMETHACIN INDOMETHACIN FERROSOFERRIC OXIDE SILICON DIOXIDE GELATIN FD&C BLUE NO. 1 FD&C YELLOW NO. 5 MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POWDERED CELLULOSE SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A CORN TITANIUM DIOXIDE GREEN CAPSULE 294;50mg indomethacin indomethacin INDOMETHACIN INDOMETHACIN FERROSOFERRIC OXIDE SILICON DIOXIDE GELATIN FD&C BLUE NO. 1 FD&C YELLOW NO. 5 MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POWDERED CELLULOSE SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A CORN TITANIUM DIOXIDE GREEN CAPSULE 293;25mg

Application Number

ANDA090403

Brand Name

Indomethacin

Generic Name

indomethacin

Product Ndc

70771-1005

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1004-01 Indomethacin capsules USP, 25 mg 100 Capsules Rx only NDC 70771-1005-01 Indomethacin capsules USP, 50 mg 100 Capsules Rx only Indomethacin Capsules, USP IndomethacineCapsules, USP

Spl Medguide

SPL MEDGUIDE

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.

Disclaimer

The drug Prescribing Information (PI), including indications, contra-indications, interactions, etc, has been developed using the U.S. Food & Drug Administration (FDA) as a source (www.fda.gov).

Medthority offers the whole library of PI documents from the FDA. Medthority will not be held liable for explicit or implicit errors, or missing data.

Drugs appearing in this section are approved by the FDA. For regions outside of the United States, this content is for informational purposes only and may not be aligned with local regulatory approvals or guidance.