Etodolac

Product NDC
63187-374
11-digit product format
631870374
Labeler code
63187
Product ID
63187-374_dd9d2003-9288-4d96-8910-705710883378
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA091134
Marketing category
ANDA
Marketing start
2014-02-15
Substance
ETODOLAC
Active strength
400 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Etodolac
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ETODOLAC400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2M36281008
Rxcui310245

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bb9faa76-10d1-4b5f-ab9b-d6a26495edb7Product name120250311
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
0c3d95a8-02c3-425e-810b-2a14408d9a06Product name420250218
24aa5265-325f-0e21-8836-2c9a907c0454Product name220210601
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-374-30Etodolac30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE303
63187-374-60Etodolac60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE603
63187-374-90Etodolac90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-374-30EA - Each63187-37446e6bc93-af9a-4b2f-887d-748de895a6cc12016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-374ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20210115_4712e069-83b6-4052-8d95-f59ab1dba744.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310245etodolac 400 MG 24HR Extended Release Oral TabletPSN4712e069-83b6-4052-8d95-f59ab1dba7443
31024524 HR etodolac 400 MG Extended Release Oral TabletSCD4712e069-83b6-4052-8d95-f59ab1dba7443
310245etodolac 400 MG 24 HR Extended Release Oral TabletSY4712e069-83b6-4052-8d95-f59ab1dba7443

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-374-306318703743030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-374-30) 2016-09-010000-00-00NoNoCurrent
63187-374-606318703746060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-374-60) 2016-09-010000-00-00NoNoCurrent
63187-374-906318703749090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-374-90) 2016-09-010000-00-00NoNoCurrent