Etodolac

Product NDC
60760-298
11-digit product format
607600298
Labeler code
60760
Product ID
60760-298_52303a5a-b336-24bf-e063-6294a90a53a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
St. Mary's Medical Park Pharmacy
Application
ANDA091134
Marketing category
ANDA
Marketing start
2018-03-14
Substance
ETODOLAC
Active strength
500 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
ETODOLAC500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2M36281008
Rxcui359500

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bb9faa76-10d1-4b5f-ab9b-d6a26495edb7Product name120250311
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
0c3d95a8-02c3-425e-810b-2a14408d9a06Product name420250218
24aa5265-325f-0e21-8836-2c9a907c0454Product name220210601
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60760-298-15Etodolac15 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE154

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-298-15EA - Each60760-2986a93e3ab-6306-4a48-bd5d-9043504efd7912018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-298ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [ST. MARY'S MEDICAL PARK PHARMACY]2Current NDC, Legacy NDC, 1 package rows20181115_6761e6b1-2399-4643-e053-2991aa0a6f17.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359500etodolac 500 MG 24HR Extended Release Oral TabletPSN6761e6b1-2399-4643-e053-2991aa0a6f174
35950024 HR etodolac 500 MG Extended Release Oral TabletSCD6761e6b1-2399-4643-e053-2991aa0a6f174
359500etodolac 500 MG 24 HR Extended Release Oral TabletSY6761e6b1-2399-4643-e053-2991aa0a6f174

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60760-298-156076002981515 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60760-298-15) 2018-03-140000-00-00NoNoCurrent