INDOCIN
These highlights do not include all the information needed to use INDOCIN® SUPPOSITORIES (INDOMETHACIN SUPPOSITORIES) safely and effectively. See full prescribing information for INDOCIN SUPPOSITORIES (INDOMETHACIN SUPPOSITORIES). INDOCIN Suppositories (Indomethacin Suppositories), for rectal use Initial U.S. Approval: 1965
Approved
Approval ID
3b36645c-de5e-4263-ae06-2f6ff6a9add2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 27, 2023
Manufacturers
FDA
Zyla Life Sciences US LLC
DUNS: 079581441
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 Code69344-102
Application NumberANDA073314
Product Classification
M
Marketing Category
C73584
G
Generic Name
Indomethacin
Product Specifications
Route of AdministrationRECTAL
Effective DateNovember 23, 2022
FDA Product Classification
INGREDIENTS (9)
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
EDETIC ACIDInactive
Code: 9G34HU7RV0
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
INDOMETHACINActive
Quantity: 50 mg in 1 1
Code: XXE1CET956
Classification: ACTIB
Drug Labeling Information
BOXED WARNING SECTION
LOINC: 34066-1Updated: 4/18/2021
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS