Etodolac

Product NDC
63187-736
11-digit product format
631870736
Labeler code
63187
Product ID
63187-736_1df6a536-d2d9-4d3b-bc5b-91e7a26beed2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA076004
Marketing category
ANDA
Marketing start
2003-05-01
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
63187-736-20Etodolac20 in 1 BOTTLETABLET, FILM COATED205
63187-736-30Etodolac30 in 1 BOTTLETABLET, FILM COATED305
63187-736-60Etodolac60 in 1 BOTTLETABLET, FILM COATED605
63187-736-90Etodolac90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-736ETODOLAC TABLET, FILM COATED [PROFICIENT RX LP]5Current NDC, Legacy NDC, 4 package rows20230811_e2fef939-2f4a-46ae-8177-073f5e8f57f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197686etodolac 400 MG Oral TabletPSNe2fef939-2f4a-46ae-8177-073f5e8f57f55
197686etodolac 400 MG Oral TabletSCDe2fef939-2f4a-46ae-8177-073f5e8f57f55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-736-206318707362020 TABLET, FILM COATED in 1 BOTTLE (63187-736-20) 2016-08-010000-00-00NoNoCurrent
63187-736-306318707363030 TABLET, FILM COATED in 1 BOTTLE (63187-736-30) 2016-08-010000-00-00NoNoCurrent
63187-736-606318707366060 TABLET, FILM COATED in 1 BOTTLE (63187-736-60) 2016-08-010000-00-00NoNoCurrent
63187-736-906318707369090 TABLET, FILM COATED in 1 BOTTLE (63187-736-90) 2016-08-010000-00-00NoNoCurrent