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INDOCIN

These highlights do not include all the information needed to use INDOCIN ORAL SUSPENSION safely and effectively. See full prescribing information for INDOCIN . INDOCIN ( indomethacin ) Oral Suspension , for oral use Initial U.S. Approval: 1965

Approved
Approval ID

06de3c9d-63bf-47c1-f78c-4fbdd482928a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 28, 2018

Manufacturers
FDA

Iroko Pharmaceuticals, LLC

DUNS: 796831217

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

indomethacin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42211-101
Application NumberNDA018332
Product Classification
M
Marketing Category
C73594
G
Generic Name
indomethacin
Product Specifications
Route of AdministrationORAL
Effective DateMay 17, 2018
FDA Product Classification

INGREDIENTS (8)

INDOMETHACINActive
Quantity: 25 mg in 5 mL
Code: XXE1CET956
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
TRAGACANTHInactive
Code: 2944357O2O
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT

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INDOCIN - FDA Drug Approval Details