Indomethacin

Basic Information

Product Name

Indomethacin

FDA Product Code

72865-148

Regulatory Information

NDC Product Code

72865-148

Application Number

ANDA091240

Marketing Category

C73584

Effective Date

January 16, 2023

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

INDOMETHACIN

Quantity: 25 mg in 1 1

Code: XXE1CET956

Class Code: ACTIB

GELATIN

Code: 2G86QN327L

Class Code: IACT

Active Moieties

Code: XXE1CET956

Indomethacin

Basic Information

Regulatory Information

Company Information

Active Ingredients

MAGNESIUM STEARATE

SODIUM LAURYL SULFATE

LACTOSE MONOHYDRATE

SILICON DIOXIDE

SODIUM STARCH GLYCOLATE TYPE A POTATO

TITANIUM DIOXIDE

FD&C BLUE NO. 1

D&C YELLOW NO. 10

FERROSOFERRIC OXIDE

GELATIN

Active Moieties

INDOMETHACIN