Etodolac

Product NDC
53217-371
11-digit product format
532170371
Labeler code
53217
Product ID
53217-371_c9efb85c-6792-4afb-b727-7ff82539cace
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA076004
Marketing category
ANDA
Marketing start
2003-05-01
Marketing end
0000-00-00
Substance
ETODOLAC
Active strength
400 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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-371-20Etodolac20 in 1 BOTTLETABLET, FILM COATED201
53217-371-30Etodolac30 in 1 BOTTLETABLET, FILM COATED301
53217-371-60Etodolac60 in 1 BOTTLETABLET, FILM COATED601
53217-371-90Etodolac90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-371ETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 4 package rows20180405_000b5b37-3873-4007-b3be-ad99a9904bed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197686etodolac 400 MG Oral TabletPSN000b5b37-3873-4007-b3be-ad99a9904bed1
197686etodolac 400 MG Oral TabletSCD000b5b37-3873-4007-b3be-ad99a9904bed1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-371-205321703712020 in 1 BOTTLEHistorical
53217-371-305321703713030 in 1 BOTTLEHistorical
53217-371-605321703716060 in 1 BOTTLEHistorical
53217-371-905321703719090 in 1 BOTTLEHistorical