Etodolac

Product NDC
69238-1342
11-digit product format
692381342
Labeler code
69238
Product ID
69238-1342_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
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, 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
69238-1342-1Etodolac100 in 1 BOTTLETABLET, FILM COATED10010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1342-1EA - Each69238-1342e3a7364f-a074-4163-a438-d3daead488b912018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1342ETODOLAC 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
197686etodolac 400 MG Oral TabletPSN00125d63-d8d0-46c5-bdf1-80d2c85eda5a14
197686etodolac 400 MG Oral TabletSCD00125d63-d8d0-46c5-bdf1-80d2c85eda5a14
197686etodolac 400 MG Oral TabletPSN336d5331-4d60-42e2-8cfc-aad57c01eda011
197686etodolac 400 MG Oral TabletSCD336d5331-4d60-42e2-8cfc-aad57c01eda011
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
197686etodolac 400 MG Oral TabletPSN55ae2e78-d803-496b-b66d-af11403127857
197686etodolac 400 MG Oral TabletSCD55ae2e78-d803-496b-b66d-af11403127857
197686etodolac 400 MG Oral TabletPSNc18497e2-9fca-4500-e053-2a95a90a1bcc6
197686etodolac 400 MG Oral TabletSCDc18497e2-9fca-4500-e053-2a95a90a1bcc6
197686etodolac 400 MG Oral TabletPSN53160db5-ba48-4cac-afbe-acd608daa0dc5
197686etodolac 400 MG Oral TabletSCD53160db5-ba48-4cac-afbe-acd608daa0dc5
197686etodolac 400 MG Oral TabletPSNb0880f39-a6fa-23ab-e053-2995a90a7eb24
197686etodolac 400 MG Oral TabletPSNcdde46e5-1123-410f-aafc-0c6e904a5d5b4
197686etodolac 400 MG Oral TabletSCDb0880f39-a6fa-23ab-e053-2995a90a7eb24
197686etodolac 400 MG Oral TabletSCDcdde46e5-1123-410f-aafc-0c6e904a5d5b4
197686etodolac 400 MG Oral TabletPSN113558e6-8b45-cdbd-e063-6394a90ac0362
197686etodolac 400 MG Oral TabletSCD113558e6-8b45-cdbd-e063-6394a90ac0362

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69238-1342-169238134201100 TABLET, FILM COATED in 1 BOTTLE (69238-1342-1) 2018-06-110000-00-00NoNoCurrent