Indomethacin
INDOMETHACIN CAPSULES USP Rx only
Approved
Approval ID
4755e174-f5d7-451a-9649-46222a6dfced
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 29, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-523
Application NumberANDA070756
Product Classification
M
Marketing Category
C73584
G
Generic Name
Indomethacin
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 10, 2008
FDA Product Classification
INGREDIENTS (17)
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
IndomethacinActive
Quantity: 50 mg in 1 1
Code: XXE1CET956
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
gelatinInactive
Code: 2G86QN327L
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C RED NO. 7Inactive
Code: ECW0LZ41X8
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT