Etodolac

Product NDC
71610-816
11-digit product format
716100816
Labeler code
71610
Product ID
71610-816_1547fa22-2822-34ef-e063-6394a90aee62
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA075074
Marketing category
ANDA
Marketing start
1998-03-11
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
71610-816-537161008165360 TABLET, FILM COATED in 1 BOTTLE (71610-816-53) 2024-04-03NoNoHistorical
71610-816-607161008166090 TABLET, FILM COATED in 1 BOTTLE (71610-816-60) 2024-04-03NoNoHistorical
71610-816-8071610081680180 TABLET, FILM COATED in 1 BOTTLE (71610-816-80) 2024-04-03NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Etodolac Capsules and Tablets, USPAphena Pharma Solutions - Tennessee, LLC2024-04-04HUMAN PRESCRIPTION DRUG LABEL1