Etodolac

Product NDC
43353-918
11-digit product format
433530918
Labeler code
43353
Product ID
43353-918_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
200 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
43353-918-534335309185360 CAPSULE in 1 BOTTLE, PLASTIC (43353-918-53) 60 capsule2015-02-250000-00-00NoNoCurrent
43353-918-604335309186090 CAPSULE in 1 BOTTLE, PLASTIC (43353-918-60) 90 capsule2015-02-250000-00-00NoNoCurrent
43353-918-7043353091870120 CAPSULE in 1 BOTTLE, PLASTIC (43353-918-70) 120 capsule2015-02-250000-00-00NoNoCurrent
43353-918-8043353091880180 CAPSULE in 1 BOTTLE, PLASTIC (43353-918-80) 180 capsule2015-02-250000-00-00NoNoCurrent
43353-918-87433530918872400 CAPSULE in 1 BOTTLE, PLASTIC (43353-918-87) 2400 capsule2014-04-020000-00-00NoNoCurrent

Related DailyMed Labels

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