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FDA Drug information

Indomethacin

Read time: 1 mins
Marketing start date: 23 Dec 2024
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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

70771-1004

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

Drug section

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