Etodolac

Product NDC
80425-0140
11-digit product format
804250140
Labeler code
80425
Product ID
80425-0140_2a99b1dd-becc-79f9-e063-6394a90a35f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA208834
Marketing category
ANDA
Marketing start
2018-06-11
Substance
ETODOLAC
Active strength
400 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
80425-0140-28042501400260 TABLET, FILM COATED in 1 BOTTLE (80425-0140-2) 2018-06-11NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Etodolac TabletsAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL6