Etodolac

Product NDC
71205-140
11-digit product format
712050140
Labeler code
71205
Product ID
71205-140_524617eb-4404-4d2e-8d0c-478294af8a27
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA075665
Marketing category
ANDA
Marketing start
2001-02-09
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
0c3d95a8-02c3-425e-810b-2a14408d9a06Product name420250218
24aa5265-325f-0e21-8836-2c9a907c0454Product name220210601

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-140-30Etodolac30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE303
71205-140-60Etodolac60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE603
71205-140-90Etodolac90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-140ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20241024_5a040d8e-8d0c-442f-b4e5-161aa7ccbe9a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310245etodolac 400 MG 24HR Extended Release Oral TabletPSN5a040d8e-8d0c-442f-b4e5-161aa7ccbe9a3
31024524 HR etodolac 400 MG Extended Release Oral TabletSCD5a040d8e-8d0c-442f-b4e5-161aa7ccbe9a3
310245etodolac 400 MG 24 HR Extended Release Oral TabletSY5a040d8e-8d0c-442f-b4e5-161aa7ccbe9a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-140-307120501403030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-140-30) 2018-10-310000-00-00NoNoCurrent
71205-140-607120501406060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-140-60) 2018-10-310000-00-00NoNoCurrent
71205-140-907120501409090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-140-90) 2018-10-310000-00-00NoNoCurrent