Etodolac

Product NDC
60760-552
11-digit product format
607600552
Labeler code
60760
Product ID
60760-552_453703bf-d4ba-d090-e063-6394a90a7ebf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
St. Mary�s Medical Park Pharmacy
Application
ANDA076004
Marketing category
ANDA
Marketing start
2015-11-12
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Etodolac
Listing expiration
2026-12-31

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
60760-552-14Etodolac14 in 1 BOTTLE, PLASTICTABLET, FILM COATED148
60760-552-20Etodolac20 in 1 BOTTLE, PLASTICTABLET, FILM COATED208
60760-552-28Etodolac28 in 1 BOTTLE, PLASTICTABLET, FILM COATED288
60760-552-60Etodolac60 in 1 BOTTLE, PLASTICTABLET, FILM COATED608

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-552ETODOLAC TABLET, FILM COATED [ST. MARY’S MEDICAL PARK PHARMACY]7Current NDC, Legacy NDC, 4 package rows20241215_60cb4de0-ed88-a46b-e053-2a91aa0a8b6d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197686etodolac 400 MG Oral TabletPSN60cb4de0-ed88-a46b-e053-2a91aa0a8b6d8
197686etodolac 400 MG Oral TabletSCD60cb4de0-ed88-a46b-e053-2a91aa0a8b6d8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60760-552-146076005521414 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-552-14) 2018-03-050000-00-00NoNoCurrent
60760-552-206076005522020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-552-20) 2015-11-120000-00-00NoNoCurrent
60760-552-286076005522828 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-552-28) 2018-03-050000-00-00NoNoCurrent
60760-552-606076005526060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-552-60) 2015-11-120000-00-00NoNoCurrent