FDA.reportPublic FDA data

Etodolac

Product NDC
33261-043
11-digit product format
332610043
Labeler code
33261
Product ID
33261-043_f67ac41b-c0aa-4443-8468-fc7e2f975da7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA075009
Marketing category
ANDA
Marketing start
1998-05-20
Marketing end
0000-00-00
Substance
ETODOLAC
Active strength
400 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33261-043-022020-01-31C16284748780-19d75b9d0-a2a6-f424-e053-dadaa90a57ceETODOLAC TABLETS USP 0892 1893 Rx only
33261-043-202020-01-31C16284748780-19d75b9d0-a2a6-f424-e053-dadaa90a57ceETODOLAC TABLETS USP 0892 1893 Rx only
33261-043-302020-01-31C16284748780-19d75b9d0-a2a6-f424-e053-dadaa90a57ceETODOLAC TABLETS USP 0892 1893 Rx only
33261-043-602020-01-31C16284748780-19d75b9d0-a2a6-f424-e053-dadaa90a57ceETODOLAC TABLETS USP 0892 1893 Rx only
33261-043-902020-01-31C16284748780-19d75b9d0-a2a6-f424-e053-dadaa90a57ceETODOLAC TABLETS USP 0892 1893 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-043-02Etodolac120 in 1 BOTTLE, PLASTICTABLET, FILM COATED1202
33261-043-20Etodolac20 in 1 BOTTLE, PLASTICTABLET, FILM COATED202
33261-043-30Etodolac30 in 1 BOTTLE, PLASTICTABLET, FILM COATED302
33261-043-60Etodolac60 in 1 BOTTLE, PLASTICTABLET, FILM COATED602
33261-043-90Etodolac90 in 1 BOTTLE, PLASTICTABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-043-02EA - Each33261-043b9d45b20-7b04-4172-966c-44f09229728912015-10-02
33261-043-20EA - Each33261-0431415b732-35a9-4780-9744-43460bd718bc12015-10-02
33261-043-30EA - Each33261-043c39fe84c-885c-4ff3-92f8-cbc2aa9fa20812015-10-02
33261-043-60EA - Each33261-043e86e1a68-af28-4aad-a0b6-c4cc0981af9e12015-10-02
33261-043-90EA - Each33261-043bf21cd22-1efe-40c3-bccb-eae2fb83379f12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETODOLACACTIVE INGREDIENT2M36281008ETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
ETODOLACACTIVE MOIETY2M36281008ETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-043ETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2Legacy NDC, 5 package rows20140107_dc441b8f-1012-4d07-bdb7-ce0c85480533.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197686etodolac 400 MG Oral TabletPSNdc441b8f-1012-4d07-bdb7-ce0c854805332
199390etodolac 500 MG Oral TabletPSNdc441b8f-1012-4d07-bdb7-ce0c854805332
197686etodolac 400 MG Oral TabletSCDdc441b8f-1012-4d07-bdb7-ce0c854805332
199390etodolac 500 MG Oral TabletSCDdc441b8f-1012-4d07-bdb7-ce0c854805332

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-043-0233261004302120 in 1 BOTTLE, PLASTICHistorical
33261-043-203326100432020 in 1 BOTTLE, PLASTICHistorical
33261-043-303326100433030 in 1 BOTTLE, PLASTICHistorical
33261-043-603326100436060 in 1 BOTTLE, PLASTICHistorical
33261-043-903326100439090 in 1 BOTTLE, PLASTICHistorical