Etodolac

Product NDC
43353-752
11-digit product format
433530752
Labeler code
43353
Product ID
43353-752_fbe19c2c-9e78-41d9-9455-21ed571956e5
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
Marketing end
0000-00-00
Substance
ETODOLAC
Active strength
400 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
2M36281008ETODOLAC41340-25-4ETODOLAC

Packages

Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43353-752-534335307525360 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-752-53) 2011-08-160000-00-00NoNoCurrent
43353-752-604335307526090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-752-60) 2011-08-160000-00-00NoNoCurrent
43353-752-8043353075280180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-752-80) 2011-08-080000-00-00NoNoCurrent
43353-752-83433530752833600 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-752-83) 2014-04-020000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Etodolac Capsules, Tablets and ER Tablets, USPAphena Pharma Solutions - Tennessee, LLC2019-12-19HUMAN PRESCRIPTION DRUG LABEL3