ETODOLAC
Etodolac Tablets
Approved
Approval ID
82ef8726-d6c8-458a-86d5-4ec5fd514681
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 12, 2011
Manufacturers
FDA
RedPharm Drug Inc.
DUNS: 008039641
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 Code67296-0595
Application NumberANDA074819
Product Classification
M
Marketing Category
C73584
G
Generic Name
etodolac
Product Specifications
Route of AdministrationORAL
Effective DateJuly 12, 2011
FDA Product Classification
INGREDIENTS (11)
EtodolacActive
Quantity: 400 mg in 1 1
Code: 2M36281008
Classification: ACTIB
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
Polyethylene Glycol 400Inactive
Code: B697894SGQ
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2910 (15000 MPA.S)Inactive
Code: 288VBX44JC
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
PovidoneInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT