Etodolac

Product NDC
60429-313
11-digit product format
604290313
Labeler code
60429
Product ID
60429-313_2a31440b-f2e8-1530-e063-6394a90abd6c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA076174
Marketing category
ANDA
Marketing start
2003-03-13
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
Rxcui310245, 310247, 359500

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bb9faa76-10d1-4b5f-ab9b-d6a26495edb7Product name120250311
0c3d95a8-02c3-425e-810b-2a14408d9a06Product name420250218
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
24aa5265-325f-0e21-8836-2c9a907c0454Product name220210601

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60429-313-01Etodolac100 in 1 BOTTLETABLET, EXTENDED RELEASE1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-313-01EA - Each60429-3133e895997-33cb-41fb-8b59-8891a2b1578f12012-07-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60429-313ETODOLAC TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]4Current NDC, Legacy NDC, 1 package rows20250101_c59c5108-a09b-2a03-e053-2995a90abba1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310245etodolac 400 MG 24HR Extended Release Oral TabletPSNc59c5108-a09b-2a03-e053-2995a90abba14
359500etodolac 500 MG 24HR Extended Release Oral TabletPSNc59c5108-a09b-2a03-e053-2995a90abba14
310247etodolac 600 MG 24HR Extended Release Oral TabletPSNc59c5108-a09b-2a03-e053-2995a90abba14
31024524 HR etodolac 400 MG Extended Release Oral TabletSCDc59c5108-a09b-2a03-e053-2995a90abba14
35950024 HR etodolac 500 MG Extended Release Oral TabletSCDc59c5108-a09b-2a03-e053-2995a90abba14
31024724 HR etodolac 600 MG Extended Release Oral TabletSCDc59c5108-a09b-2a03-e053-2995a90abba14
310245etodolac 400 MG 24 HR Extended Release Oral TabletSYc59c5108-a09b-2a03-e053-2995a90abba14
359500etodolac 500 MG 24 HR Extended Release Oral TabletSYc59c5108-a09b-2a03-e053-2995a90abba14
310247etodolac 600 MG 24 HR Extended Release Oral TabletSYc59c5108-a09b-2a03-e053-2995a90abba14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60429-313-0160429031301100 TABLET, EXTENDED RELEASE in 1 BOTTLE (60429-313-01) 2011-07-180000-00-00NoNoCurrent