ETODOLAC

Product NDC
52959-483
11-digit product format
529590483
Labeler code
52959
Product ID
52959-483_6869dcc1-23e7-4007-e053-2991aa0a4b2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ETODOLAC
Dosage form
CAPSULE
Route
ORAL
Labeler
H. J. Harkins Co., Inc
Application
ANDA075126
Marketing category
ANDA
Marketing start
2017-12-27
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
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
52959-483-142020-01-31C16284748780-19d75b9d1-190e-f424-e053-dadaa90a57ce6869dcc1-23e6-4007-e053-2991aa0a4b2c
52959-483-212020-01-31C16284748780-19d75b9d1-190e-f424-e053-dadaa90a57ce6869dcc1-23e6-4007-e053-2991aa0a4b2c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-483-14ETODOLAC14 in 1 VIALCAPSULE141
52959-483-21ETODOLAC21 in 1 VIALCAPSULE211

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-483-21EA - Each52959-483e1e6199f-62b8-4950-8c33-6528628494cc12018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-483ETODOLAC CAPSULE [H. J. HARKINS CO., INC]1Legacy NDC, 2 package rows20180328_6869dcc1-23e6-4007-e053-2991aa0a4b2c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197685etodolac 300 MG Oral CapsulePSN6869dcc1-23e6-4007-e053-2991aa0a4b2c1
197685etodolac 300 MG Oral CapsuleSCD6869dcc1-23e6-4007-e053-2991aa0a4b2c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-483-145295904831414 in 1 VIALHistorical
52959-483-215295904832121 in 1 VIALHistorical