Etodolac

Product NDC
63187-374
11-digit product format
631870374
Labeler code
63187
Product ID
63187-374_dd9d2003-9288-4d96-8910-705710883378
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA091134
Marketing category
ANDA
Marketing start
2014-02-15
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
63187-374-306318703743030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-374-30) 2016-09-01NoNoHistorical
63187-374-606318703746060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-374-60) 2016-09-01NoNoHistorical
63187-374-906318703749090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-374-90) 2016-09-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Etodolac Extended-release Tablets, USPProficient Rx LP2021-01-01HUMAN PRESCRIPTION DRUG LABEL3