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Etodolac

Etodolac Extended-Release Tablets, USP

Approved
Approval ID

1e4824cc-4d52-4f20-9674-cfcb9ee66574

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 10, 2023

Manufacturers
FDA

Bryant Ranch Prepack

DUNS: 171714327

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 Code63629-8598
Application NumberANDA091134
Product Classification
M
Marketing Category
C73584
G
Generic Name
Etodolac
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2022
FDA Product Classification

INGREDIENTS (13)

MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
ETODOLACActive
Quantity: 600 mg in 1 1
Code: 2M36281008
Classification: ACTIB
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
ETHYLCELLULOSE (100 MPA.S)Inactive
Code: 47MLB0F1MV
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT

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Etodolac - FDA Drug Approval Details