Etodolac

Product NDC
71335-0982
11-digit product format
713350982
Labeler code
71335
Product ID
71335-0982_daca716b-058d-47da-b814-0ad4865c8d7a
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
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
71335-0982-1Etodolac20 in 1 BOTTLETABLET, FILM COATED205
71335-0982-2Etodolac14 in 1 BOTTLETABLET, FILM COATED145
71335-0982-3Etodolac30 in 1 BOTTLETABLET, FILM COATED305
71335-0982-4Etodolac100 in 1 BOTTLETABLET, FILM COATED1005
71335-0982-5Etodolac60 in 1 BOTTLETABLET, FILM COATED605
71335-0982-6Etodolac90 in 1 BOTTLETABLET, FILM COATED905
71335-0982-7Etodolac56 in 1 BOTTLETABLET, FILM COATED565
71335-0982-8Etodolac120 in 1 BOTTLETABLET, FILM COATED1205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0982ETODOLAC TABLET, FILM COATED [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 8 package rows20240410_53160db5-ba48-4cac-afbe-acd608daa0dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197686etodolac 400 MG Oral TabletPSN53160db5-ba48-4cac-afbe-acd608daa0dc5
197686etodolac 400 MG Oral TabletSCD53160db5-ba48-4cac-afbe-acd608daa0dc5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0982-17133509820120 TABLET, FILM COATED in 1 BOTTLE (71335-0982-1) 2018-11-090000-00-00NoNoCurrent
71335-0982-27133509820214 TABLET, FILM COATED in 1 BOTTLE (71335-0982-2) 2024-04-090000-00-00NoNoCurrent
71335-0982-37133509820330 TABLET, FILM COATED in 1 BOTTLE (71335-0982-3) 2018-10-300000-00-00NoNoCurrent
71335-0982-471335098204100 TABLET, FILM COATED in 1 BOTTLE (71335-0982-4) 2024-04-090000-00-00NoNoCurrent
71335-0982-57133509820560 TABLET, FILM COATED in 1 BOTTLE (71335-0982-5) 2018-11-280000-00-00NoNoCurrent
71335-0982-67133509820690 TABLET, FILM COATED in 1 BOTTLE (71335-0982-6) 2024-04-090000-00-00NoNoCurrent
71335-0982-77133509820756 TABLET, FILM COATED in 1 BOTTLE (71335-0982-7) 2018-12-190000-00-00NoNoCurrent
71335-0982-871335098208120 TABLET, FILM COATED in 1 BOTTLE (71335-0982-8) 2024-04-090000-00-00NoNoCurrent