Etodolac

Product NDC
71335-1230
11-digit product format
713351230
Labeler code
71335
Product ID
71335-1230_f91abb0f-25ae-4086-81b9-6d23820e5108
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
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
71335-1230-12024-05-20C16284748780-11030e365-4fcb-111a-e063-dadaa90a10e2Etodolac Tablets, USP (400 mg and 500 mg) Rx only
71335-1230-22024-05-20C16284748780-11030e365-4fcb-111a-e063-dadaa90a10e2Etodolac Tablets, USP (400 mg and 500 mg) Rx only
71335-1230-32024-05-20C16284748780-11030e365-4fcb-111a-e063-dadaa90a10e2Etodolac Tablets, USP (400 mg and 500 mg) Rx only
71335-1230-42024-05-20C16284748780-11030e365-4fcb-111a-e063-dadaa90a10e2Etodolac Tablets, USP (400 mg and 500 mg) Rx only
71335-1230-52024-05-20C16284748780-11030e365-4fcb-111a-e063-dadaa90a10e2Etodolac Tablets, USP (400 mg and 500 mg) Rx only
71335-1230-62024-05-20C16284748780-11030e365-4fcb-111a-e063-dadaa90a10e2Etodolac Tablets, USP (400 mg and 500 mg) Rx only
71335-1230-72024-05-20C16284748780-11030e365-4fcb-111a-e063-dadaa90a10e2Etodolac Tablets, USP (400 mg and 500 mg) Rx only
71335-1230-12024-01-30C16284748780-11030e365-4fcb-111a-e063-dadaa90a10e2Etodolac Tablets, USP (400 mg and 500 mg) Rx only
71335-1230-22024-01-30C16284748780-11030e365-4fcb-111a-e063-dadaa90a10e2Etodolac Tablets, USP (400 mg and 500 mg) Rx only
71335-1230-32024-01-30C16284748780-11030e365-4fcb-111a-e063-dadaa90a10e2Etodolac Tablets, USP (400 mg and 500 mg) Rx only
71335-1230-42024-01-30C16284748780-11030e365-4fcb-111a-e063-dadaa90a10e2Etodolac Tablets, USP (400 mg and 500 mg) Rx only
71335-1230-52024-01-30C16284748780-11030e365-4fcb-111a-e063-dadaa90a10e2Etodolac Tablets, USP (400 mg and 500 mg) Rx only
71335-1230-62024-01-30C16284748780-11030e365-4fcb-111a-e063-dadaa90a10e2Etodolac Tablets, USP (400 mg and 500 mg) Rx only
71335-1230-72024-01-30C16284748780-11030e365-4fcb-111a-e063-dadaa90a10e2Etodolac Tablets, USP (400 mg and 500 mg) Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1230-1Etodolac60 in 1 BOTTLETABLET, FILM COATED60101
71335-1230-2Etodolac90 in 1 BOTTLETABLET, FILM COATED90101
71335-1230-3Etodolac30 in 1 BOTTLETABLET, FILM COATED30101
71335-1230-4Etodolac100 in 1 BOTTLETABLET, FILM COATED100101
71335-1230-5Etodolac6 in 1 BOTTLETABLET, FILM COATED6101
71335-1230-6Etodolac20 in 1 BOTTLETABLET, FILM COATED20101
71335-1230-7Etodolac14 in 1 BOTTLETABLET, FILM COATED14101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1230ETODOLAC TABLET, FILM COATED [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 7 package rows20240522_4b0d1245-8d01-4fff-9783-cb30c17d9246.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199390etodolac 500 MG Oral TabletPSN4b0d1245-8d01-4fff-9783-cb30c17d9246101
199390etodolac 500 MG Oral TabletSCD4b0d1245-8d01-4fff-9783-cb30c17d9246101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1230-17133512300160 TABLET, FILM COATED in 1 BOTTLE (71335-1230-1) 2019-05-280000-00-00NoNoCurrent
71335-1230-27133512300290 TABLET, FILM COATED in 1 BOTTLE (71335-1230-2) 2024-05-170000-00-00NoNoCurrent
71335-1230-37133512300330 TABLET, FILM COATED in 1 BOTTLE (71335-1230-3) 2024-05-170000-00-00NoNoCurrent
71335-1230-471335123004100 TABLET, FILM COATED in 1 BOTTLE (71335-1230-4) 2024-05-170000-00-00NoNoCurrent
71335-1230-5713351230056 TABLET, FILM COATED in 1 BOTTLE (71335-1230-5) 2024-05-170000-00-00NoNoCurrent
71335-1230-67133512300620 TABLET, FILM COATED in 1 BOTTLE (71335-1230-6) 2024-05-170000-00-00NoNoCurrent
71335-1230-77133512300714 TABLET, FILM COATED in 1 BOTTLE (71335-1230-7) 2024-05-170000-00-00NoNoCurrent