Etodolac

Product NDC
71335-2259
11-digit product format
713352259
Labeler code
71335
Product ID
71335-2259_2b889026-2eb9-4894-a68d-2fcf5a3ceae4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210704
Marketing category
ANDA
Marketing start
2021-08-01
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2259-1Etodolac20 in 1 BOTTLETABLET, FILM COATED20101
71335-2259-2Etodolac14 in 1 BOTTLETABLET, FILM COATED14101
71335-2259-3Etodolac30 in 1 BOTTLETABLET, FILM COATED30101
71335-2259-4Etodolac100 in 1 BOTTLETABLET, FILM COATED100101
71335-2259-5Etodolac60 in 1 BOTTLETABLET, FILM COATED60101
71335-2259-6Etodolac90 in 1 BOTTLETABLET, FILM COATED90101
71335-2259-7Etodolac56 in 1 BOTTLETABLET, FILM COATED56101
71335-2259-8Etodolac120 in 1 BOTTLETABLET, FILM COATED120101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2259ETODOLAC TABLET, FILM COATED [BRYANT RANCH PREPACK]100Current NDC, 8 package rows20231031_5e94a98f-d36e-4f28-b79c-6ad8a6793381.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197686etodolac 400 MG Oral TabletPSN5e94a98f-d36e-4f28-b79c-6ad8a6793381101
197686etodolac 400 MG Oral TabletSCD5e94a98f-d36e-4f28-b79c-6ad8a6793381101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2259-17133522590120 TABLET, FILM COATED in 1 BOTTLE (71335-2259-1) 2023-10-30NoNoCurrent
71335-2259-27133522590214 TABLET, FILM COATED in 1 BOTTLE (71335-2259-2) 2023-10-30NoNoCurrent
71335-2259-37133522590330 TABLET, FILM COATED in 1 BOTTLE (71335-2259-3) 2023-10-30NoNoCurrent
71335-2259-471335225904100 TABLET, FILM COATED in 1 BOTTLE (71335-2259-4) 2023-10-30NoNoCurrent
71335-2259-57133522590560 TABLET, FILM COATED in 1 BOTTLE (71335-2259-5) 2023-10-30NoNoCurrent
71335-2259-67133522590690 TABLET, FILM COATED in 1 BOTTLE (71335-2259-6) 2023-10-30NoNoCurrent
71335-2259-77133522590756 TABLET, FILM COATED in 1 BOTTLE (71335-2259-7) 2023-10-30NoNoCurrent
71335-2259-871335225908120 TABLET, FILM COATED in 1 BOTTLE (71335-2259-8) 2023-10-30NoNoCurrent