FDA.reportPublic FDA data

Etodolac

Product NDC
76385-119
11-digit product format
763850119
Labeler code
76385
Product ID
76385-119_c135c9a7-8a1d-4383-b373-a1dbf711567a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unichem Pharmaceuticals (USA), Inc.
Application
ANDA210704
Marketing category
ANDA
Marketing start
2021-08-01
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76385-119-012025-07-09C16284748780-12cef2736-a703-d83d-e063-dadaa90ab31fETODOLAC TABLETS USP Rx only
76385-119-012025-01-30C16284748780-12cef2736-a703-d83d-e063-dadaa90ab31fETODOLAC TABLETS USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76385-119-01Etodolac100 in 1 BOTTLETABLET, FILM COATED1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76385-119-01EA - Each76385-1196de128ab-1bf9-4463-9961-b7bb1879e89012021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76385-119ETODOLAC TABLET, FILM COATED [BAYSHORE PHARMACEUTICALS, LLC]2Current NDC, Legacy NDC, 1 package rows20230111_18215cb7-c833-4a98-a61d-4bedf518a380.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197686etodolac 400 MG Oral TabletPSN18215cb7-c833-4a98-a61d-4bedf518a3804
199390etodolac 500 MG Oral TabletPSN18215cb7-c833-4a98-a61d-4bedf518a3804
197686etodolac 400 MG Oral TabletSCD18215cb7-c833-4a98-a61d-4bedf518a3804
199390etodolac 500 MG Oral TabletSCD18215cb7-c833-4a98-a61d-4bedf518a3804
199390etodolac 500 MG Oral TabletPSN06f602d1-6faf-41c8-bcfd-33e51f4ca6361
199390etodolac 500 MG Oral TabletSCD06f602d1-6faf-41c8-bcfd-33e51f4ca6361

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76385-119-0176385011901100 TABLET, FILM COATED in 1 BOTTLE (76385-119-01) 2021-08-010000-00-00NoNoCurrent