Etodolac
ETODOLAC TABLETS, USP 400 mg and 500 mg Rx only
Approved
Approval ID
76f5172a-9fd8-40f8-b699-cb9b1d05a614
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 10, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 2
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 Code50090-2133
Application NumberANDA076004
Product Classification
M
Marketing Category
C73584
G
Generic Name
Etodolac
Product Specifications
Route of AdministrationORAL
Effective DateNovember 3, 2022
FDA Product Classification
INGREDIENTS (8)
ETODOLACActive
Quantity: 500 mg in 1 1
Code: 2M36281008
Classification: ACTIB
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
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
POLYETHYLENE GLYCOL 1500Inactive
Code: 1212Z7S33A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Etodolac
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-1789
Application NumberANDA076004
Product Classification
M
Marketing Category
C73584
G
Generic Name
Etodolac
Product Specifications
Route of AdministrationORAL
Effective DateNovember 3, 2022
FDA Product Classification
INGREDIENTS (8)
ETODOLACActive
Quantity: 400 mg in 1 1
Code: 2M36281008
Classification: ACTIB
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
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
POLYETHYLENE GLYCOL 1500Inactive
Code: 1212Z7S33A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT