Etodolac

Product NDC
66336-586
11-digit product format
663360586
Labeler code
66336
Product ID
66336-586_221b9a3d-d734-443f-94b4-270a4d90fcc9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Dispensing Solutions, Inc.
Application
ANDA075665
Marketing category
ANDA
Marketing start
2001-02-09
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
66336-586-602019-11-27C16284748780-19855d018-dff4-cd31-e053-dbdaa90ab51aETODOLAC EXTENDED-RELEASE TABLETS 1122 7172 1118 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66336-586-60Etodolac60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE602

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETODOLACACTIVE INGREDIENT2M36281008ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
ETODOLACACTIVE MOIETY2M36281008ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66336-586ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2Legacy NDC, 1 package rows20130820_5841e1c3-ee29-4b6c-ac02-7daa82ad63bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310245etodolac 400 MG 24HR Extended Release Oral TabletPSN5841e1c3-ee29-4b6c-ac02-7daa82ad63bf2
31024524 HR etodolac 400 MG Extended Release Oral TabletSCD5841e1c3-ee29-4b6c-ac02-7daa82ad63bf2
310245etodolac 400 MG 24 HR Extended Release Oral TabletSY5841e1c3-ee29-4b6c-ac02-7daa82ad63bf2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66336-586-606633605866060 in 1 BOTTLEHistorical