ETODOLAC
ETODOLAC TABLETS 400 MG
Approved
Approval ID
b17228a1-38c3-4fa3-a83d-0654f18edabc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 3, 2012
Manufacturers
FDA
STAT Rx USA LLC
DUNS: 786036330
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ETODOLAC
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42549-511
Application NumberANDA076004
Product Classification
M
Marketing Category
C73584
G
Generic Name
ETODOLAC
Product Specifications
Route of AdministrationORAL
Effective DateApril 3, 2012
FDA Product Classification
INGREDIENTS (8)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHYLCELLULOSE (100 CPS)Inactive
Code: 4GFU244C4J
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
ETODOLACActive
Quantity: 400 mg in 1 1
Code: 2M36281008
Classification: ACTIB
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT