Etodolac

Product NDC
43353-294
11-digit product format
433530294
Labeler code
43353
Product ID
43353-294_f7a2760f-2274-412b-8dc6-111f547e7e03
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA075419
Marketing category
ANDA
Marketing start
2017-01-05
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-294-53EA - Each43353-29497837970-02f2-42bc-9ce8-7506d3ae369212017-11-06
43353-294-60EA - Each43353-2946cac4e73-60a4-4532-a0b7-f8187ee3d43c12017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-294ETODOLAC (ETODOLAC) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC20171021_d8edfe71-a186-4ee1-9287-d4f69fd79da4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-294-534335302945360 CAPSULE in 1 BOTTLE (43353-294-53) 60 capsule2017-03-170000-00-00NoNoCurrent
43353-294-604335302946090 CAPSULE in 1 BOTTLE (43353-294-60) 90 capsule2017-04-040000-00-00NoNoCurrent