FDA.reportPublic FDA data

ETODOLAC

Product NDC
61919-574
11-digit product format
619190574
Labeler code
61919
Product ID
61919-574_9a4e1ffa-e9e7-4d9c-aa95-70697189a77f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ETODOLAC
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA075009
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
ETODOLAC
Active strength
500 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
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
24aa5265-325f-0e21-8836-2c9a907c0454Product name220210601

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-574-302020-01-31C16284748780-19d75b9d0-8a6d-f424-e053-dadaa90a57ceETODOLAC
61919-574-602020-01-31C16284748780-19d75b9d0-8a6d-f424-e053-dadaa90a57ceETODOLAC

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-574-30ETODOLAC30 in 1 BOTTLETABLET303
61919-574-60ETODOLAC60 in 1 BOTTLETABLET603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-574-30EA - Each61919-574ec7836e6-2b08-4b2b-8d4d-37ec417fcb0512015-10-02
61919-574-60EA - Each61919-5740cae9c3e-77c5-493f-8a7e-61b5d6725d5c12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETODOLACACTIVE INGREDIENT2M36281008ETODOLAC TABLET [DIRECT RX]3
ETODOLACACTIVE MOIETY2M36281008ETODOLAC TABLET [DIRECT RX]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UETODOLAC TABLET [DIRECT RX]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKETODOLAC TABLET [DIRECT RX]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAETODOLAC TABLET [DIRECT RX]3
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82ETODOLAC TABLET [DIRECT RX]3
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4ETODOLAC TABLET [DIRECT RX]3
INDIGOTINDISULFONATE SODIUMINACTIVE INGREDIENTD3741U8K7LETODOLAC TABLET [DIRECT RX]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XETODOLAC TABLET [DIRECT RX]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ETODOLAC TABLET [DIRECT RX]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AETODOLAC TABLET [DIRECT RX]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HETODOLAC TABLET [DIRECT RX]3
POVIDONE K30INACTIVE INGREDIENTU725QWY32XETODOLAC TABLET [DIRECT RX]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ETODOLAC TABLET [DIRECT RX]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ETODOLAC TABLET [DIRECT RX]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPETODOLAC TABLET [DIRECT RX]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-574ETODOLAC TABLET [DIRECT RX]3Legacy NDC, 2 package rows20151111_c10d8ee3-ad39-4d07-9e35-4bc9202804a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199390etodolac 500 MG Oral TabletPSNc10d8ee3-ad39-4d07-9e35-4bc9202804a53
199390etodolac 500 MG Oral TabletSCDc10d8ee3-ad39-4d07-9e35-4bc9202804a53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-574-306191905743030 in 1 BOTTLEHistorical
61919-574-606191905746060 in 1 BOTTLEHistorical