FDA.reportPublic FDA data

Etodolac

Product NDC
16714-497
11-digit product format
167140497
Labeler code
16714
Product ID
16714-497_38568f45-b334-0e6f-e063-6294a90a178a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
NORTHSTAR RX LLC
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
16714-497-01Etodolac60 in 1 BOTTLETABLET, EXTENDED RELEASE605
16714-497-02Etodolac100 in 1 BOTTLETABLET, EXTENDED RELEASE1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-497-01EA - Each16714-497f23532fd-fe6e-4ad5-b532-3c5c66c7c18c12016-12-07
16714-497-02EA - Each16714-49761f7776c-97bf-4137-9e41-07cf61a9a06712016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-497ETODOLAC TABLET, EXTENDED RELEASE [NORTHSTAR RX LLC]4Current NDC, Legacy NDC, 2 package rows20241019_107ea9d7-80a9-41a4-b61e-168370127319.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310245etodolac 400 MG 24HR Extended Release Oral TabletPSN107ea9d7-80a9-41a4-b61e-1683701273195
359500etodolac 500 MG 24HR Extended Release Oral TabletPSN107ea9d7-80a9-41a4-b61e-1683701273195
310247etodolac 600 MG 24HR Extended Release Oral TabletPSN107ea9d7-80a9-41a4-b61e-1683701273195
31024524 HR etodolac 400 MG Extended Release Oral TabletSCD107ea9d7-80a9-41a4-b61e-1683701273195
35950024 HR etodolac 500 MG Extended Release Oral TabletSCD107ea9d7-80a9-41a4-b61e-1683701273195
31024724 HR etodolac 600 MG Extended Release Oral TabletSCD107ea9d7-80a9-41a4-b61e-1683701273195
310245etodolac 400 MG 24 HR Extended Release Oral TabletSY107ea9d7-80a9-41a4-b61e-1683701273195
359500etodolac 500 MG 24 HR Extended Release Oral TabletSY107ea9d7-80a9-41a4-b61e-1683701273195
310247etodolac 600 MG 24 HR Extended Release Oral TabletSY107ea9d7-80a9-41a4-b61e-1683701273195

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-497-011671404970160 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-497-01) 2016-08-150000-00-00NoNoCurrent
16714-497-0216714049702100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-497-02) 2016-08-150000-00-00NoNoCurrent