Etodolac

Product NDC
62135-911
11-digit product format
621350911
Labeler code
62135
Product ID
62135-911_458a4076-0a9b-0a2d-e063-6394a90a2fa6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA209888
Marketing category
ANDA
Marketing start
2018-12-07
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
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
ETODOLAC500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2M36281008
Rxcui197686, 199390

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
62135-911-60Etodolac60 in 1 BOTTLETABLET, FILM COATED602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-911-60EA - Each62135-91191b6ea2d-3a24-4a2e-829f-becb98d3789212024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-911ETODOLAC TABLET, FILM COATED [CHARTWELL RX, LLC]1Current NDC, 1 package rows20240913_f86d2b22-d3f7-49cd-98f6-cdb2bd855192.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197686etodolac 400 MG Oral TabletPSNf86d2b22-d3f7-49cd-98f6-cdb2bd8551922
199390etodolac 500 MG Oral TabletPSNf86d2b22-d3f7-49cd-98f6-cdb2bd8551922
197686etodolac 400 MG Oral TabletSCDf86d2b22-d3f7-49cd-98f6-cdb2bd8551922
199390etodolac 500 MG Oral TabletSCDf86d2b22-d3f7-49cd-98f6-cdb2bd8551922

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62135-911-606213509116060 TABLET, FILM COATED in 1 BOTTLE (62135-911-60) 2024-08-29NoNoHistorical