Etodolac

Product NDC
50090-1790
11-digit product format
500901790
Labeler code
50090
Product ID
50090-1790_fddf66a5-fccc-47b6-9166-0f1681972158
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076004
Marketing category
ANDA
Marketing start
2003-05-01
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
Rxcui197686

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
50090-1790-02023-02-07C16284748780-1f386c649-d970-0266-e053-dadaa90a7c1aETODOLAC TABLETS, USP 400 mg and 500 mg Rx only
50090-1790-02023-01-30C16284748780-1f386c649-d970-0266-e053-dadaa90a7c1aETODOLAC TABLETS, USP 400 mg and 500 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1790-0Etodolac20 in 1 BOTTLETABLET, FILM COATED2013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1790-0EA - Each50090-17903f2143a6-8eda-4300-b5af-d1f4f188d88f12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1790ETODOLAC TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]13Current NDC, Legacy NDC, 1 package rows20230208_74baa6ad-b517-48e2-8cef-d77f5755b279.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197686etodolac 400 MG Oral TabletPSN74baa6ad-b517-48e2-8cef-d77f5755b27913
197686etodolac 400 MG Oral TabletSCD74baa6ad-b517-48e2-8cef-d77f5755b27913

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-1790-05009017900020 TABLET, FILM COATED in 1 BOTTLE (50090-1790-0) 2015-04-240000-00-00NoNoCurrent