Etodolac

Product NDC
21695-050
11-digit product format
216950050
Labeler code
21695
Product ID
21695-050_d7cf7ed9-d7b4-4dcc-8a25-a9177c54f847
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA075074
Marketing category
ANDA
Marketing start
1998-03-11
Marketing end
0000-00-00
Substance
ETODOLAC
Active strength
400 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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
21695-050-30Etodolac30 in 1 BOTTLETABLET, FILM COATED301
21695-050-60Etodolac60 in 1 BOTTLETABLET, FILM COATED601
21695-050-90Etodolac90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-050ETODOLAC TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1Legacy NDC, 3 package rows20101119_d7cf7ed9-d7b4-4dcc-8a25-a9177c54f847.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197686etodolac 400 MG Oral TabletPSNd7cf7ed9-d7b4-4dcc-8a25-a9177c54f8471
197686etodolac 400 MG Oral TabletSCDd7cf7ed9-d7b4-4dcc-8a25-a9177c54f8471

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-050-302169500503030 in 1 BOTTLEHistorical
21695-050-602169500506060 in 1 BOTTLEHistorical
21695-050-902169500509090 in 1 BOTTLEHistorical