FDA.reportPublic FDA data

Etodolac

Product NDC
50090-3963
11-digit product format
500903963
Labeler code
50090
Product ID
50090-3963_5cf13771-ec53-43be-9b29-e977248fc22e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA208834
Marketing category
ANDA
Marketing start
2018-06-11
Substance
ETODOLAC
Active strength
400 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Etodolac
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ETODOLAC400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2M36281008
Rxcui197686

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3963-0Etodolac14 in 1 BOTTLETABLET, FILM COATED1414
50090-3963-1Etodolac20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2014
50090-3963-2Etodolac30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3014
50090-3963-5Etodolac60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3963-1EA - Each50090-3963c126bd3e-ad0d-4e56-883e-ca790947b7b512023-01-09
50090-3963-2EA - Each50090-39631ed7e3eb-3d2b-47f2-93fe-a78ddf7c7d2812021-12-08
50090-3963-5EA - Each50090-39630572d49a-915c-4fb2-ba4b-9a455c985c0012021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3963ETODOLAC TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]12Current NDC, Legacy NDC, 4 package rows20240627_00125d63-d8d0-46c5-bdf1-80d2c85eda5a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197686etodolac 400 MG Oral TabletPSN00125d63-d8d0-46c5-bdf1-80d2c85eda5a14
197686etodolac 400 MG Oral TabletSCD00125d63-d8d0-46c5-bdf1-80d2c85eda5a14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3963-05009039630014 TABLET, FILM COATED in 1 BOTTLE (50090-3963-0) 2018-12-120000-00-00NoNoCurrent
50090-3963-15009039630120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3963-1) 2018-06-110000-00-00NoNoCurrent
50090-3963-25009039630230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3963-2) 2018-06-110000-00-00NoNoCurrent
50090-3963-55009039630560 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3963-5) 2018-06-110000-00-00NoNoCurrent