Etodolac

Product NDC
63187-793
11-digit product format
631870793
Labeler code
63187
Product ID
63187-793_e29663ca-306c-4e25-a233-fe701cee7071
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA076174
Marketing category
ANDA
Marketing start
2003-03-13
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
63187-793-206318707932020 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-793-20) 2016-12-01NoNoHistorical
63187-793-306318707933030 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-793-30) 2016-12-01NoNoHistorical
63187-793-606318707936060 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-793-60) 2016-12-01NoNoHistorical
63187-793-906318707939090 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-793-90) 2016-12-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Etodolac Extended-Release Tablets, 400 mg, 500 mg and 600 mgProficient Rx LP2019-11-01HUMAN PRESCRIPTION DRUG LABEL3