FDA.reportPublic FDA data

Etodolac

Product NDC
52959-471
11-digit product format
529590471
Labeler code
52959
Product ID
52959-471_fa86884d-639e-4a55-8038-650350c81462
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
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
52959-471-022020-01-31C16284748780-19d75b9d0-980e-f424-e053-dadaa90a57ceETODOLAC TABLETS USP 0892 1893 Rx only
52959-471-122020-01-31C16284748780-19d75b9d0-980e-f424-e053-dadaa90a57ceETODOLAC TABLETS USP 0892 1893 Rx only
52959-471-142020-01-31C16284748780-19d75b9d0-980e-f424-e053-dadaa90a57ceETODOLAC TABLETS USP 0892 1893 Rx only
52959-471-152020-01-31C16284748780-19d75b9d0-980e-f424-e053-dadaa90a57ceETODOLAC TABLETS USP 0892 1893 Rx only
52959-471-202020-01-31C16284748780-19d75b9d0-980e-f424-e053-dadaa90a57ceETODOLAC TABLETS USP 0892 1893 Rx only
52959-471-252020-01-31C16284748780-19d75b9d0-980e-f424-e053-dadaa90a57ceETODOLAC TABLETS USP 0892 1893 Rx only
52959-471-282020-01-31C16284748780-19d75b9d0-980e-f424-e053-dadaa90a57ceETODOLAC TABLETS USP 0892 1893 Rx only
52959-471-302020-01-31C16284748780-19d75b9d0-980e-f424-e053-dadaa90a57ceETODOLAC TABLETS USP 0892 1893 Rx only
52959-471-602020-01-31C16284748780-19d75b9d0-980e-f424-e053-dadaa90a57ceETODOLAC TABLETS USP 0892 1893 Rx only
52959-471-902020-01-31C16284748780-19d75b9d0-980e-f424-e053-dadaa90a57ceETODOLAC TABLETS USP 0892 1893 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-471-02Etodolac120 in 1 BOTTLE, PLASTICTABLET, FILM COATED1202
52959-471-12Etodolac12 in 1 BOTTLE, PLASTICTABLET, FILM COATED122
52959-471-14Etodolac14 in 1 BOTTLE, PLASTICTABLET, FILM COATED142
52959-471-15Etodolac15 in 1 BOTTLE, PLASTICTABLET, FILM COATED152
52959-471-20Etodolac20 in 1 BOTTLE, PLASTICTABLET, FILM COATED202
52959-471-25Etodolac25 in 1 BOTTLE, PLASTICTABLET, FILM COATED252
52959-471-28Etodolac28 in 1 BOTTLE, PLASTICTABLET, FILM COATED282
52959-471-30Etodolac30 in 1 BOTTLE, PLASTICTABLET, FILM COATED302
52959-471-60Etodolac60 in 1 BOTTLE, PLASTICTABLET, FILM COATED602
52959-471-90Etodolac90 in 1 BOTTLE, PLASTICTABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-471-02EA - Each52959-47124b9f32e-a608-4136-80b2-512cad58794b12013-02-13
52959-471-12EA - Each52959-471fa79b450-e3e1-41fa-922a-28ff9a8ad91412013-02-13
52959-471-14EA - Each52959-471a2aa12cd-831e-4954-ba0b-8f057887b6fb12013-02-13
52959-471-15EA - Each52959-471aaf1c422-f318-4e7c-b318-bbb7b594d10b12013-02-13
52959-471-20EA - Each52959-471c318fad6-3061-4c5c-b249-51b4ffd521b012013-02-13
52959-471-25EA - Each52959-471a1c2ad57-c3d8-43cc-803b-3eeebcc1bb2c12013-02-13
52959-471-28EA - Each52959-47119e6baa7-ced9-47da-964a-753eed7eb55e12013-02-13
52959-471-30EA - Each52959-4718a1b8efd-d876-4b22-b013-a91a8700da5712013-02-13
52959-471-60EA - Each52959-47129b7168c-e15e-4f96-b0a2-7704ca4533d512013-02-13
52959-471-90EA - Each52959-471b2a9d001-7e51-406e-8580-0f9f5772049312013-02-13

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-471ETODOLAC TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 10 package rows20120831_cb26ac8c-294b-4705-8dd9-8c96afc33b8c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197686etodolac 400 MG Oral TabletPSNcb26ac8c-294b-4705-8dd9-8c96afc33b8c2
197686etodolac 400 MG Oral TabletSCDcb26ac8c-294b-4705-8dd9-8c96afc33b8c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-471-0252959047102120 in 1 BOTTLE, PLASTICHistorical
52959-471-125295904711212 in 1 BOTTLE, PLASTICHistorical
52959-471-145295904711414 in 1 BOTTLE, PLASTICHistorical
52959-471-155295904711515 in 1 BOTTLE, PLASTICHistorical
52959-471-205295904712020 in 1 BOTTLE, PLASTICHistorical
52959-471-255295904712525 in 1 BOTTLE, PLASTICHistorical
52959-471-285295904712828 in 1 BOTTLE, PLASTICHistorical
52959-471-305295904713030 in 1 BOTTLE, PLASTICHistorical
52959-471-605295904716060 in 1 BOTTLE, PLASTICHistorical
52959-471-905295904719090 in 1 BOTTLE, PLASTICHistorical