Indomethacin
Indomethacin 50mg
Approved
Approval ID
891ab059-a11e-0f81-e053-2995a90a03bf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 13, 2021
Manufacturers
FDA
RedPharm Drug, Inc.
DUNS: 828374897
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 Code67296-0954
Application NumberANDA091240
Product Classification
M
Marketing Category
C73584
G
Generic Name
Indomethacin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 13, 2021
FDA Product Classification
INGREDIENTS (11)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
INDOMETHACINActive
Quantity: 50 mg in 1 1
Code: XXE1CET956
Classification: ACTIB