Etodolac

Product NDC
69238-1343
11-digit product format
692381343
Labeler code
69238
Product ID
69238-1343_f5259276-4fc9-4d24-98ee-fd40a89db0d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA208834
Marketing category
ANDA
Marketing start
2018-06-11
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
69238-1343-1Etodolac100 in 1 BOTTLETABLET, FILM COATED10010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1343-1EA - Each69238-13436a61f671-3e4e-45ab-8765-dff100a85f1412018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1343ETODOLAC TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC]10Current NDC, Legacy NDC, 1 package rows20250112_2f306e69-c109-4e60-aaf3-9016a4e2cc33.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199390etodolac 500 MG Oral TabletPSN4b0d1245-8d01-4fff-9783-cb30c17d9246101
199390etodolac 500 MG Oral TabletSCD4b0d1245-8d01-4fff-9783-cb30c17d9246101
197686etodolac 400 MG Oral TabletPSN2f306e69-c109-4e60-aaf3-9016a4e2cc3310
199390etodolac 500 MG Oral TabletPSN2f306e69-c109-4e60-aaf3-9016a4e2cc3310
197686etodolac 400 MG Oral TabletSCD2f306e69-c109-4e60-aaf3-9016a4e2cc3310
199390etodolac 500 MG Oral TabletSCD2f306e69-c109-4e60-aaf3-9016a4e2cc3310
199390etodolac 500 MG Oral TabletPSN31a55fb1-9721-4202-af7d-f06074b031029
199390etodolac 500 MG Oral TabletSCD31a55fb1-9721-4202-af7d-f06074b031029
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 startMarketing endSampleExclude flagStatus
69238-1343-169238134301100 TABLET, FILM COATED in 1 BOTTLE (69238-1343-1) 2018-06-110000-00-00NoNoCurrent