Etodolac

Product NDC
80425-0181
11-digit product format
804250181
Labeler code
80425
Product ID
80425-0181_2a99a670-af34-299d-e063-6294a90a05d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA076174
Marketing category
ANDA
Marketing start
2003-03-13
Substance
ETODOLAC
Active strength
600 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
2M36281008ETODOLAC41340-25-4ETODOLAC

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80425-0181-18042501810130 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0181-1) 2003-03-13NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Etodolac ER TabletsAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL4