Etodolac

Product NDC
42254-052
11-digit product format
422540052
Labeler code
42254
Product ID
42254-052_7e2f72a2-a76f-46a0-9a0b-4414633bb864
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA075009
Marketing category
ANDA
Marketing start
2010-04-30
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
42254-052-302019-09-24C16284748780-19350213a-3d43-c013-e053-90daa90a1393ETODOLAC TABLETS USP Rx only
42254-052-602019-09-24C16284748780-19350213a-3d43-c013-e053-90daa90a1393ETODOLAC TABLETS USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-052-30Etodolac30 in 1 BOTTLETABLET, FILM COATED301
42254-052-60Etodolac60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-052-30EA - Each42254-0525e1c4733-c033-4b1e-a032-3337f3d3b63c12012-07-24
42254-052-60EA - Each42254-052ad7ac3f1-4c06-491b-8382-47435baddf2812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETODOLACACTIVE INGREDIENT2M36281008ETODOLAC TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
ETODOLACACTIVE MOIETY2M36281008ETODOLAC TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UETODOLAC TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ETODOLAC TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GETODOLAC TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKETODOLAC TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAETODOLAC TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOETODOLAC TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XETODOLAC TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ETODOLAC TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AETODOLAC TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HETODOLAC TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EETODOLAC TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ETODOLAC TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPETODOLAC TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-052ETODOLAC TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20120316_7e2f72a2-a76f-46a0-9a0b-4414633bb864.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197686etodolac 400 MG Oral TabletPSN7e2f72a2-a76f-46a0-9a0b-4414633bb8641
197686etodolac 400 MG Oral TabletSCD7e2f72a2-a76f-46a0-9a0b-4414633bb8641

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-052-304225400523030 in 1 BOTTLEHistorical
42254-052-604225400526060 in 1 BOTTLEHistorical