FDA.reportPublic FDA data

Etodolac

Product NDC
68788-8846
11-digit product format
687888846
Labeler code
68788
Product ID
68788-8846_556a7d5f-2c3c-4efb-ac0c-fca140791602
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA076004
Marketing category
ANDA
Marketing start
2025-03-24
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
68788-8846-1Etodolac100 in 1 BOTTLETABLET, FILM COATED1001
68788-8846-2Etodolac20 in 1 BOTTLETABLET, FILM COATED201
68788-8846-3Etodolac30 in 1 BOTTLETABLET, FILM COATED301
68788-8846-6Etodolac60 in 1 BOTTLETABLET, FILM COATED601
68788-8846-9Etodolac90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8846-1EA - Each68788-8846f1bb7d8a-855d-4f99-bc6f-814f82bdafc512025-05-14
68788-8846-2EA - Each68788-8846116114df-db5c-48d0-946a-c37039efee2612025-05-14
68788-8846-3EA - Each68788-88461d05bfc2-f1d4-4f34-b8b2-19cb8a02a55c12025-05-14
68788-8846-6EA - Each68788-88463e7f7933-da97-4fbd-b8d2-23bd47f795cc12025-05-14
68788-8846-9EA - Each68788-8846ac5f0be5-db45-4e2a-8e66-f1c201e6c73b12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8846ETODOLAC TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 5 package rows20250326_556a7d5f-2c3c-4efb-ac0c-fca140791602.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197686etodolac 400 MG Oral TabletPSN556a7d5f-2c3c-4efb-ac0c-fca1407916021
197686etodolac 400 MG Oral TabletSCD556a7d5f-2c3c-4efb-ac0c-fca1407916021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8846-168788884601100 TABLET, FILM COATED in 1 BOTTLE (68788-8846-1) 2025-03-24NoNoCurrent
68788-8846-26878888460220 TABLET, FILM COATED in 1 BOTTLE (68788-8846-2) 2025-03-24NoNoCurrent
68788-8846-36878888460330 TABLET, FILM COATED in 1 BOTTLE (68788-8846-3) 2025-03-24NoNoCurrent
68788-8846-66878888460660 TABLET, FILM COATED in 1 BOTTLE (68788-8846-6) 2025-03-24NoNoCurrent
68788-8846-96878888460990 TABLET, FILM COATED in 1 BOTTLE (68788-8846-9) 2025-03-24NoNoCurrent