Indomethacin extended-release
Indomethacin Extended-Release Capsules USP
Approved
Approval ID
3125cb9f-d00c-47e7-9927-fbe38cadb48b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 12, 2010
Manufacturers
FDA
Keltman Pharmaceuticals Inc.
DUNS: 362861077
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Indomethacin extended-release
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68387-345
Application NumberANDA074464
Product Classification
M
Marketing Category
C73584
G
Generic Name
Indomethacin extended-release
Product Specifications
Route of AdministrationORAL
Effective DateJuly 12, 2010
FDA Product Classification
INGREDIENTS (16)
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ETHYLCELLULOSEInactive
Code: 7Z8S9VYZ4B
Classification: IACT
INDOMETHACINActive
Quantity: 75 mg in 1 1
Code: XXE1CET956
Classification: ACTIB
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT