FDA.reportPublic FDA data

Etodolac

Product NDC
51672-4051
11-digit product format
516724051
Labeler code
51672
Product ID
51672-4051_28681979-a277-8b4c-e063-6394a90a2235
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Taro Pharmaceuticals U.S.A., 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
51672-4051-1Etodolac100 in 1 BOTTLETABLET, EXTENDED RELEASE1007
51672-4051-2Etodolac500 in 1 BOTTLETABLET, EXTENDED RELEASE5007
51672-4051-3Etodolac1000 in 1 BOTTLETABLET, EXTENDED RELEASE10007
51672-4051-4Etodolac60 in 1 BOTTLETABLET, EXTENDED RELEASE607
51672-4051-6Etodolac30 in 1 BOTTLETABLET, EXTENDED RELEASE307
51672-4051-9Etodolac10 in 1 CARTONTABLET, EXTENDED RELEASE107
51672-4051-9Etodolac6 in 1 BLISTER PACKTABLET, EXTENDED RELEASE67

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4051-1EA - Each51672-4051af3a7808-071d-4f1c-8d9e-bc907d62cf5c12012-07-24
51672-4051-4EA - Each51672-4051c205efe2-a07b-4ddf-b5ef-37bc6212123712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EtodolacACTIVE INGREDIENT2M36281008ETODOLAC TABLET, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]2
EtodolacACTIVE MOIETY2M36281008ETODOLAC TABLET, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]2
Aluminum OxideINACTIVE INGREDIENTLMI26O6933ETODOLAC TABLET, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]2
Anhydrous LactoseINACTIVE INGREDIENT3SY5LH9PMKETODOLAC TABLET, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]2
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UETODOLAC TABLET, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]2
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOAETODOLAC TABLET, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]2
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8ETODOLAC TABLET, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]2
Ferric Oxide YellowINACTIVE INGREDIENTEX438O2MRTETODOLAC TABLET, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]2
HypromellosesINACTIVE INGREDIENT3NXW29V3WOETODOLAC TABLET, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]2
Indigotindisulfonate SodiumINACTIVE INGREDIENTD3741U8K7LETODOLAC TABLET, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]2
Magnesium StearateINACTIVE INGREDIENT70097M6I30ETODOLAC TABLET, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]2
PolydextroseINACTIVE INGREDIENTVH2XOU12IEETODOLAC TABLET, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]2
Polyethylene Glycol 8000INACTIVE INGREDIENTQ662QK8M3BETODOLAC TABLET, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]2
PovidonesINACTIVE INGREDIENTFZ989GH94EETODOLAC TABLET, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]2
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPETODOLAC TABLET, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]2
TriacetinINACTIVE INGREDIENTXHX3C3X673ETODOLAC TABLET, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4051ETODOLAC TABLET, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]7Current NDC, Legacy NDC, 7 package rows20241206_2c5b44b4-78d5-43b2-827d-d2763b6672b3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310245etodolac 400 MG 24HR Extended Release Oral TabletPSN2c5b44b4-78d5-43b2-827d-d2763b6672b37
359500etodolac 500 MG 24HR Extended Release Oral TabletPSN2c5b44b4-78d5-43b2-827d-d2763b6672b37
310247etodolac 600 MG 24HR Extended Release Oral TabletPSN2c5b44b4-78d5-43b2-827d-d2763b6672b37
31024524 HR etodolac 400 MG Extended Release Oral TabletSCD2c5b44b4-78d5-43b2-827d-d2763b6672b37
35950024 HR etodolac 500 MG Extended Release Oral TabletSCD2c5b44b4-78d5-43b2-827d-d2763b6672b37
31024724 HR etodolac 600 MG Extended Release Oral TabletSCD2c5b44b4-78d5-43b2-827d-d2763b6672b37
310245etodolac 400 MG 24 HR Extended Release Oral TabletSY2c5b44b4-78d5-43b2-827d-d2763b6672b37
359500etodolac 500 MG 24 HR Extended Release Oral TabletSY2c5b44b4-78d5-43b2-827d-d2763b6672b37
310247etodolac 600 MG 24 HR Extended Release Oral TabletSY2c5b44b4-78d5-43b2-827d-d2763b6672b37
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
310245etodolac 400 MG 24HR Extended Release Oral TabletPSN449b273a-936a-4c49-b0c8-d0daa47733ae3
31024524 HR etodolac 400 MG Extended Release Oral TabletSCD449b273a-936a-4c49-b0c8-d0daa47733ae3
310245etodolac 400 MG 24 HR Extended Release Oral TabletSY449b273a-936a-4c49-b0c8-d0daa47733ae3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-4051-151672405101100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4051-1) 2003-03-130000-00-00NoNoCurrent
51672-4051-251672405102500 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4051-2) 2003-03-130000-00-00NoNoCurrent
51672-4051-3516724051031000 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4051-3) 2003-03-130000-00-00NoNoCurrent
51672-4051-45167240510460 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4051-4) 2003-03-130000-00-00NoNoCurrent
51672-4051-65167240510630 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4051-6) 2003-03-130000-00-00NoNoCurrent
51672-4051-95167240510910 BLISTER PACK in 1 CARTON (51672-4051-9) / 6 TABLET, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2003-03-130000-00-00NoNoCurrent