Etodolac

Product NDC
66336-878
11-digit product format
663360878
Labeler code
66336
Product ID
66336-878_1ceb01db-7890-43fa-b31c-1c73a56e7032
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dispensing Solutions, 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],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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
66336-878-902019-11-27C16284748780-19855d018-d7d5-cd31-e053-dbdaa90ab51aETODOLAC TABLETS USP 0892 1893 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66336-878-90Etodolac90 in 1 BOTTLE, PLASTICTABLET, FILM COATED902

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66336-878ETODOLAC TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2Legacy NDC, 1 package rows20130927_11093e14-5d31-4079-8dd2-c69f722d2810.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197686etodolac 400 MG Oral TabletPSN11093e14-5d31-4079-8dd2-c69f722d28102
197686etodolac 400 MG Oral TabletSCD11093e14-5d31-4079-8dd2-c69f722d28102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66336-878-906633608789090 in 1 BOTTLE, PLASTICHistorical