Etodolac

Product NDC
43353-753
11-digit product format
433530753
Labeler code
43353
Product ID
43353-753_fbe19c2c-9e78-41d9-9455-21ed571956e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA075078
Marketing category
ANDA
Marketing start
1998-04-05
Marketing end
0000-00-00
Substance
ETODOLAC
Active strength
300 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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-753-304335307533030 CAPSULE in 1 BOTTLE, PLASTIC (43353-753-30) 30 capsule2015-02-250000-00-00NoNoCurrent
43353-753-534335307535360 CAPSULE in 1 BOTTLE, PLASTIC (43353-753-53) 60 capsule2011-08-110000-00-00NoNoCurrent
43353-753-604335307536090 CAPSULE in 1 BOTTLE, PLASTIC (43353-753-60) 90 capsule2011-08-110000-00-00NoNoCurrent
43353-753-7043353075370120 CAPSULE in 1 BOTTLE, PLASTIC (43353-753-70) 120 capsule2015-02-250000-00-00NoNoCurrent
43353-753-8043353075380180 CAPSULE in 1 BOTTLE, PLASTIC (43353-753-80) 180 capsule2015-02-250000-00-00NoNoCurrent
43353-753-87433530753872400 CAPSULE in 1 BOTTLE, PLASTIC (43353-753-87) 2400 capsule2014-02-110000-00-00NoNoCurrent

Related DailyMed Labels

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