Indomethacin
Indomethacin Extended Release Capsules, USP
Approved
Approval ID
f2f59f63-fcda-2a80-e053-2995a90ab087
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 23, 2023
Manufacturers
FDA
Northwind Pharmaceuticals, LLC
DUNS: 036986393
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 Code51655-443
Application NumberANDA201807
Product Classification
M
Marketing Category
C73584
G
Generic Name
Indomethacin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 23, 2023
FDA Product Classification
INGREDIENTS (17)
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
INDOMETHACINActive
Quantity: 75 mg in 1 1
Code: XXE1CET956
Classification: ACTIB
POTASSIUM CATIONInactive
Code: 295O53K152
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT