FDA.reportPublic FDA data

Etodolac

Product NDC
50090-1489
11-digit product format
500901489
Labeler code
50090
Product ID
50090-1489_acf9b78d-3241-46c9-9859-ae180ce6433d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075074
Marketing category
ANDA
Marketing start
2000-04-25
Substance
ETODOLAC
Active strength
500 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
ETODOLAC500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2M36281008
Rxcui197686, 199390

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
50090-1489-0Etodolac20 in 1 BOTTLETABLET, FILM COATED2013
50090-1489-5Etodolac60 in 1 BOTTLETABLET, FILM COATED6013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1489-5EA - Each50090-1489c93a7477-5686-4a30-99c2-963f1185096112025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1489ETODOLAC TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]13Current NDC, 2 package rows20250207_a7d91fcf-7928-4c9e-862b-6922d6e47c9d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197686etodolac 400 MG Oral TabletPSNa7d91fcf-7928-4c9e-862b-6922d6e47c9d13
199390etodolac 500 MG Oral TabletPSNa7d91fcf-7928-4c9e-862b-6922d6e47c9d13
197686etodolac 400 MG Oral TabletSCDa7d91fcf-7928-4c9e-862b-6922d6e47c9d13
199390etodolac 500 MG Oral TabletSCDa7d91fcf-7928-4c9e-862b-6922d6e47c9d13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-1489-05009014890020 in 1 BOTTLEHistorical
50090-1489-55009014890560 TABLET, FILM COATED in 1 BOTTLE (50090-1489-5) 2014-12-04NoNoHistorical