FDA.reportPublic FDA data

Etodolac

Product NDC
50090-3974
11-digit product format
500903974
Labeler code
50090
Product ID
50090-3974_a9574834-3e3e-446d-a32d-3fb19d874a75
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA208834
Marketing category
ANDA
Marketing start
2018-06-11
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
Rxcui199390

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3974-02023-06-29C16284748780-1f386c649-a5c6-0266-e053-dadaa90a7c1aEtodolac Tablets, USP (400 mg and 500 mg) Rx only
50090-3974-52023-06-29C16284748780-1f386c649-a5c6-0266-e053-dadaa90a7c1aEtodolac Tablets, USP (400 mg and 500 mg) Rx only
50090-3974-02023-01-30C16284748780-1f386c649-a5c6-0266-e053-dadaa90a7c1aEtodolac Tablets, USP (400 mg and 500 mg) Rx only
50090-3974-52023-01-30C16284748780-1f386c649-a5c6-0266-e053-dadaa90a7c1aEtodolac Tablets, USP (400 mg and 500 mg) Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3974-0Etodolac20 in 1 BOTTLETABLET, FILM COATED209
50090-3974-5Etodolac60 in 1 BOTTLETABLET, FILM COATED609

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3974-5EA - Each50090-397455f2bc84-9f2e-429b-927b-3248da3c2eb912021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3974ETODOLAC TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 2 package rows20230630_31a55fb1-9721-4202-af7d-f06074b03102.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199390etodolac 500 MG Oral TabletPSN31a55fb1-9721-4202-af7d-f06074b031029
199390etodolac 500 MG Oral TabletSCD31a55fb1-9721-4202-af7d-f06074b031029

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3974-05009039740020 TABLET, FILM COATED in 1 BOTTLE (50090-3974-0) 2018-12-130000-00-00NoNoCurrent
50090-3974-55009039740560 TABLET, FILM COATED in 1 BOTTLE (50090-3974-5) 2018-12-130000-00-00NoNoCurrent