Etodolac

Product NDC
52959-649
11-digit product format
529590649
Labeler code
52959
Product ID
52959-649_5566541f-5f89-2902-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
H.J. HARKINS COMPANY, INC.
Application
ANDA091134
Marketing category
ANDA
Marketing start
2017-03-06
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
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bb9faa76-10d1-4b5f-ab9b-d6a26495edb7Product name120250311
0c3d95a8-02c3-425e-810b-2a14408d9a06Product name420250218
24aa5265-325f-0e21-8836-2c9a907c0454Product name220210601

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-649-152020-01-31C16284748780-19d75b9d0-8c3e-f424-e053-dadaa90a57ce5566541f-5f88-2902-e054-00144ff88e88
52959-649-302020-01-31C16284748780-19d75b9d0-8c3e-f424-e053-dadaa90a57ce5566541f-5f88-2902-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-649-15Etodolac15 in 1 VIALTABLET, FILM COATED, EXTENDED RE151
52959-649-30Etodolac30 in 1 VIALTABLET, FILM COATED, EXTENDED RE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-649ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 2 package rows20170731_5566541f-5f88-2902-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359500etodolac 500 MG 24HR Extended Release Oral TabletPSN5566541f-5f88-2902-e054-00144ff88e881
35950024 HR etodolac 500 MG Extended Release Oral TabletSCD5566541f-5f88-2902-e054-00144ff88e881
359500etodolac 500 MG 24 HR Extended Release Oral TabletSY5566541f-5f88-2902-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-649-155295906491515 in 1 VIALHistorical
52959-649-305295906493030 in 1 VIALHistorical