FDA.reportPublic FDA data

Etodolac

Product NDC
60505-0041
11-digit product format
605050041
Labeler code
60505
Product ID
60505-0041_2da02bc5-af97-2998-e639-79e3197375b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA076004
Marketing category
ANDA
Marketing start
2003-05-01
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
60505-0041-1Etodolac100 in 1 BOTTLETABLET, FILM COATED10016
60505-0041-2Etodolac500 in 1 BOTTLETABLET, FILM COATED50016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0041-1EA - Each60505-0041afbac5a4-38be-4949-a771-cbf64f0dcfb012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETODOLACACTIVE INGREDIENT2M36281008ETODOLAC TABLET, FILM COATED [APOTEX CORP.]5
ETODOLACACTIVE MOIETY2M36281008ETODOLAC TABLET, FILM COATED [APOTEX CORP.]5
CROSPOVIDONEINACTIVE INGREDIENT68401960MKETODOLAC TABLET, FILM COATED [APOTEX CORP.]5
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PETODOLAC TABLET, FILM COATED [APOTEX CORP.]5
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712KETODOLAC TABLET, FILM COATED [APOTEX CORP.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ETODOLAC TABLET, FILM COATED [APOTEX CORP.]5
METHYLCELLULOSE (100 CPS)INACTIVE INGREDIENT4GFU244C4JETODOLAC TABLET, FILM COATED [APOTEX CORP.]5
POLYETHYLENE GLYCOL 1500INACTIVE INGREDIENT1212Z7S33AETODOLAC TABLET, FILM COATED [APOTEX CORP.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPETODOLAC TABLET, FILM COATED [APOTEX CORP.]5
EtodolacACTIVE INGREDIENT2M36281008ETODOLAC TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]4
etodolacACTIVE MOIETY2M36281008ETODOLAC TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKETODOLAC TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]4
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PETODOLAC TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOETODOLAC TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ETODOLAC TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]4
METHYLCELLULOSE (100 CPS)INACTIVE INGREDIENT4GFU244C4JETODOLAC TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AETODOLAC TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPETODOLAC TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]4
ETODOLACACTIVE INGREDIENT2M36281008ETODOLAC TABLET, FILM COATED [STAT RX USA LLC]1
ETODOLACACTIVE MOIETY2M36281008ETODOLAC TABLET, FILM COATED [STAT RX USA LLC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKETODOLAC TABLET, FILM COATED [STAT RX USA LLC]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PETODOLAC TABLET, FILM COATED [STAT RX USA LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOETODOLAC TABLET, FILM COATED [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ETODOLAC TABLET, FILM COATED [STAT RX USA LLC]1
METHYLCELLULOSE (100 CPS)INACTIVE INGREDIENT4GFU244C4JETODOLAC TABLET, FILM COATED [STAT RX USA LLC]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AETODOLAC TABLET, FILM COATED [STAT RX USA LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPETODOLAC TABLET, FILM COATED [STAT RX USA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0041ETODOLAC TABLET, FILM COATED [APOTEX CORP.]15Current NDC, Legacy NDC, 2 package rows20240809_4d682f98-1e8a-4c2b-6df3-169d2ed10dc1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197686etodolac 400 MG Oral TabletPSN479bce92-2066-46ed-b4bb-8c7a59edfffd104
197686etodolac 400 MG Oral TabletSCD479bce92-2066-46ed-b4bb-8c7a59edfffd104
197686etodolac 400 MG Oral TabletPSN007c55fa-ef8b-4a8e-bfe5-e47c6e5da72726
197686etodolac 400 MG Oral TabletSCD007c55fa-ef8b-4a8e-bfe5-e47c6e5da72726
197686etodolac 400 MG Oral TabletPSN556eaa67-d30d-4095-a981-c65f98d3acdd17
197686etodolac 400 MG Oral TabletSCD556eaa67-d30d-4095-a981-c65f98d3acdd17
197686etodolac 400 MG Oral TabletPSN4d682f98-1e8a-4c2b-6df3-169d2ed10dc116
199390etodolac 500 MG Oral TabletPSN4d682f98-1e8a-4c2b-6df3-169d2ed10dc116
197686etodolac 400 MG Oral TabletSCD4d682f98-1e8a-4c2b-6df3-169d2ed10dc116
199390etodolac 500 MG Oral TabletSCD4d682f98-1e8a-4c2b-6df3-169d2ed10dc116
197686etodolac 400 MG Oral TabletPSN74baa6ad-b517-48e2-8cef-d77f5755b27913
197686etodolac 400 MG Oral TabletSCD74baa6ad-b517-48e2-8cef-d77f5755b27913
197686etodolac 400 MG Oral TabletPSNbe53bc5c-4294-44a7-b28c-7db3f925396d12
199390etodolac 500 MG Oral TabletPSNbe53bc5c-4294-44a7-b28c-7db3f925396d12
197686etodolac 400 MG Oral TabletSCDbe53bc5c-4294-44a7-b28c-7db3f925396d12
199390etodolac 500 MG Oral TabletSCDbe53bc5c-4294-44a7-b28c-7db3f925396d12
197686etodolac 400 MG Oral TabletPSN60cb4de0-ed88-a46b-e053-2a91aa0a8b6d8
197686etodolac 400 MG Oral TabletSCD60cb4de0-ed88-a46b-e053-2a91aa0a8b6d8
197686etodolac 400 MG Oral TabletPSNdd44aa6d-8d52-4b4f-99fc-20f3cf28e2225
197686etodolac 400 MG Oral TabletPSNe2fef939-2f4a-46ae-8177-073f5e8f57f55
197686etodolac 400 MG Oral TabletPSN3b3610c8-b937-41a4-e054-00144ff88e885
197686etodolac 400 MG Oral TabletSCD3b3610c8-b937-41a4-e054-00144ff88e885
197686etodolac 400 MG Oral TabletSCDe2fef939-2f4a-46ae-8177-073f5e8f57f55
197686etodolac 400 MG Oral TabletSCDdd44aa6d-8d52-4b4f-99fc-20f3cf28e2225
197686etodolac 400 MG Oral TabletPSNd83d9f30-c367-f8b3-e053-2a95a90a1f404
197686etodolac 400 MG Oral TabletSCDd83d9f30-c367-f8b3-e053-2a95a90a1f404
197686etodolac 400 MG Oral TabletPSN80e9d756-9278-48bb-bfdd-7d070ae0f3412
197686etodolac 400 MG Oral TabletSCD80e9d756-9278-48bb-bfdd-7d070ae0f3412
197686etodolac 400 MG Oral TabletPSN556a7d5f-2c3c-4efb-ac0c-fca1407916021
197686etodolac 400 MG Oral TabletPSNb17228a1-38c3-4fa3-a83d-0654f18edabc1
197686etodolac 400 MG Oral TabletPSN1a38815e-1903-4f03-b83e-9780c71d49711
197686etodolac 400 MG Oral TabletPSN141be3f6-198d-ce46-e063-6294a90a79931
197686etodolac 400 MG Oral TabletPSN000b5b37-3873-4007-b3be-ad99a9904bed1
197686etodolac 400 MG Oral TabletSCD000b5b37-3873-4007-b3be-ad99a9904bed1
197686etodolac 400 MG Oral TabletSCD556a7d5f-2c3c-4efb-ac0c-fca1407916021
197686etodolac 400 MG Oral TabletSCD141be3f6-198d-ce46-e063-6294a90a79931
197686etodolac 400 MG Oral TabletSCD1a38815e-1903-4f03-b83e-9780c71d49711
197686etodolac 400 MG Oral TabletSCDb17228a1-38c3-4fa3-a83d-0654f18edabc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-0041-160505004101100 TABLET, FILM COATED in 1 BOTTLE (60505-0041-1) 2003-05-010000-00-00NoNoCurrent
60505-0041-260505004102500 TABLET, FILM COATED in 1 BOTTLE (60505-0041-2) 2003-05-010000-00-00NoNoCurrent