Etodolac

Product NDC
70518-3845
11-digit product format
705183845
Labeler code
70518
Product ID
70518-3845_3f8b50d9-8a00-0133-e063-6394a90a402e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA076004
Marketing category
ANDA
Marketing start
2023-08-30
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3845-0Etodolac60 in 1 BOTTLE, PLASTICTABLET, FILM COATED605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3845ETODOLAC TABLET, FILM COATED [REMEDYREPACK INC.]4Current NDC, 1 package rows20241211_cad9b5ca-a9d4-41d4-aff2-67d0c458aad6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199390etodolac 500 MG Oral TabletPSNcad9b5ca-a9d4-41d4-aff2-67d0c458aad65
199390etodolac 500 MG Oral TabletSCDcad9b5ca-a9d4-41d4-aff2-67d0c458aad65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-3845-07051838450060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3845-0) 2023-08-30NoNoCurrent