Etodolac
ETODOLAC TABLETS, USP 400 mg and 500 mg Rx only
Approved
Approval ID
556a7d5f-2c3c-4efb-ac0c-fca140791602
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 24, 2025
Manufacturers
FDA
Preferred Pharmaceuticals Inc.
DUNS: 791119022
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 Code68788-8846
Application NumberANDA076004
Product Classification
M
Marketing Category
C73584
G
Generic Name
Etodolac
Product Specifications
Route of AdministrationORAL
Effective DateMarch 24, 2025
FDA Product Classification
INGREDIENTS (8)
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHYLCELLULOSE (100 MPA.S)Inactive
Code: 4GFU244C4J
Classification: IACT
ETODOLACActive
Quantity: 400 mg in 1 1
Code: 2M36281008
Classification: ACTIB
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
POLYETHYLENE GLYCOL 1600Inactive
Code: 1212Z7S33A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT