ETODOLAC

Product NDC
67296-0595
11-digit product format
672960595
Labeler code
67296
Product ID
67296-0595_1f185c52-0399-4844-8e3e-6b48c6c221b1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
etodolac
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RedPharm Drug Inc.
Application
ANDA074819
Marketing category
ANDA
Marketing start
2008-12-01
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
2018-12-31
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
67296-0595-12020-01-31C16284748780-19d75b9d1-25e3-f424-e053-dadaa90a57ceEtodolac Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0595-1ETODOLAC15 in 1 BOTTLETABLET, FILM COATED151

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EtodolacACTIVE INGREDIENT2M36281008ETODOLAC TABLET, FILM COATED [REDPHARM DRUG INC.]1
EtodolacACTIVE MOIETY2M36281008ETODOLAC TABLET, FILM COATED [REDPHARM DRUG INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UETODOLAC TABLET, FILM COATED [REDPHARM DRUG INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ETODOLAC TABLET, FILM COATED [REDPHARM DRUG INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTETODOLAC TABLET, FILM COATED [REDPHARM DRUG INC.]1
HYPROMELLOSE 2910 (15000 MPA.S)INACTIVE INGREDIENT288VBX44JCETODOLAC TABLET, FILM COATED [REDPHARM DRUG INC.]1
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XETODOLAC TABLET, FILM COATED [REDPHARM DRUG INC.]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30ETODOLAC TABLET, FILM COATED [REDPHARM DRUG INC.]1
Polyethylene Glycol 400INACTIVE INGREDIENTB697894SGQETODOLAC TABLET, FILM COATED [REDPHARM DRUG INC.]1
PovidoneINACTIVE INGREDIENTFZ989GH94EETODOLAC TABLET, FILM COATED [REDPHARM DRUG INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ETODOLAC TABLET, FILM COATED [REDPHARM DRUG INC.]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPETODOLAC TABLET, FILM COATED [REDPHARM DRUG INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0595ETODOLAC TABLET, FILM COATED [REDPHARM DRUG INC.]1Legacy NDC, 1 package rows20110714_82ef8726-d6c8-458a-86d5-4ec5fd514681.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197686etodolac 400 MG Oral TabletPSN82ef8726-d6c8-458a-86d5-4ec5fd5146811
197686etodolac 400 MG Oral TabletSCD82ef8726-d6c8-458a-86d5-4ec5fd5146811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67296-0595-16729605950115 in 1 BOTTLEHistorical