Etodolac

Product NDC
71335-0399
11-digit product format
713350399
Labeler code
71335
Product ID
71335-0399_51096aec-e133-4461-94c1-d591a81b3df7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076004
Marketing category
ANDA
Marketing start
2003-05-01
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0399-1Etodolac60 in 1 BOTTLETABLET, FILM COATED6012
71335-0399-2Etodolac90 in 1 BOTTLETABLET, FILM COATED9012
71335-0399-3Etodolac30 in 1 BOTTLETABLET, FILM COATED3012
71335-0399-4Etodolac100 in 1 BOTTLETABLET, FILM COATED10012
71335-0399-5Etodolac6 in 1 BOTTLETABLET, FILM COATED612
71335-0399-6Etodolac20 in 1 BOTTLETABLET, FILM COATED2012
71335-0399-7Etodolac14 in 1 BOTTLETABLET, FILM COATED1412

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0399-3EA - Each71335-03994ad18241-fbdf-40b6-8910-8f4c7cb22c3a12022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0399ETODOLAC TABLET, FILM COATED [BRYANT RANCH PREPACK]12Current NDC, Legacy NDC, 7 package rows20240913_be53bc5c-4294-44a7-b28c-7db3f925396d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197686etodolac 400 MG Oral TabletPSNbe53bc5c-4294-44a7-b28c-7db3f925396d12
199390etodolac 500 MG Oral TabletPSNbe53bc5c-4294-44a7-b28c-7db3f925396d12
197686etodolac 400 MG Oral TabletSCDbe53bc5c-4294-44a7-b28c-7db3f925396d12
199390etodolac 500 MG Oral TabletSCDbe53bc5c-4294-44a7-b28c-7db3f925396d12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0399-17133503990160 TABLET, FILM COATED in 1 BOTTLE (71335-0399-1) 2024-09-050000-00-00NoNoCurrent
71335-0399-27133503990290 TABLET, FILM COATED in 1 BOTTLE (71335-0399-2) 2024-09-050000-00-00NoNoCurrent
71335-0399-37133503990330 TABLET, FILM COATED in 1 BOTTLE (71335-0399-3) 2024-09-050000-00-00NoNoCurrent
71335-0399-471335039904100 TABLET, FILM COATED in 1 BOTTLE (71335-0399-4) 2024-09-050000-00-00NoNoCurrent
71335-0399-5713350399056 TABLET, FILM COATED in 1 BOTTLE (71335-0399-5) 2024-09-050000-00-00NoNoCurrent
71335-0399-67133503990620 TABLET, FILM COATED in 1 BOTTLE (71335-0399-6) 2024-09-050000-00-00NoNoCurrent
71335-0399-77133503990714 TABLET, FILM COATED in 1 BOTTLE (71335-0399-7) 2024-09-050000-00-00NoNoCurrent