Etodolac

Product NDC
51655-735
11-digit product format
516550735
Labeler code
51655
Product ID
51655-735_4b99739a-1194-c227-e063-6294a90a72ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA208834
Marketing category
ANDA
Marketing start
2021-07-08
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Etodolac
Listing expiration
2027-12-31

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
51655-735-52Etodolac30 in 1 BOTTLE, PLASTICTABLET, FILM COATED304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-735ETODOLAC TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]1Current NDC, 1 package rows20230303_da34581d-3066-711c-e053-2995a90a8e84.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199390etodolac 500 MG Oral TabletPSNda34581d-3066-711c-e053-2995a90a8e844
199390etodolac 500 MG Oral TabletSCDda34581d-3066-711c-e053-2995a90a8e844

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-735-525165507355230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-735-52) 2021-07-08NoNoHistorical