Etodolac

Product NDC
43353-749
11-digit product format
433530749
Labeler code
43353
Product ID
43353-749_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
1998-03-12
Marketing end
0000-00-00
Substance
ETODOLAC
Active strength
500 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
43353-749-534335307495360 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-749-53) 2011-08-080000-00-00NoNoCurrent
43353-749-56433530749563000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-749-56) 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