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