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FDA Drug information

Indomethacin

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

Summary of product characteristics


Effective Time

20230926

Version

5

Spl Product Data Elements

indomethacin indomethacin INDOMETHACIN INDOMETHACIN STARCH, CORN FD&C BLUE NO. 1 HYPROMELLOSES LACTOSE MONOHYDRATE CELLULOSE, MICROCRYSTALLINE SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE GELATIN SHELLAC PROPYLENE GLYCOL AMMONIA FERROSOFERRIC OXIDE POTASSIUM HYDROXIDE WATER DARK BLUE DARK BLUE CAPSULE ZA;79;75mg

Application Number

ANDA202711

Brand Name

Indomethacin

Generic Name

indomethacin

Product Ndc

70771-1203

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1203-6 Indomethacin Extended-release Capsules, 75 mg 60 Capsules Rx only label

Spl Medguide

SPL MEDGUIDE

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