FDA.reportPublic FDA data

Etodolac

Product NDC
0093-1122
11-digit product format
000931122
Labeler code
0093
Product ID
0093-1122_05075c98-6f18-44d0-84d4-28d169638e85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA075665
Marketing category
ANDA
Marketing start
2001-02-09
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
24aa5265-325f-0e21-8836-2c9a907c0454Product name220210601

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-1122-01Etodolac100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-1122-01EA - Each0093-112267a7ca61-ff2b-485d-9817-923aba4e0acb12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETODOLACACTIVE INGREDIENT2M36281008ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]6
ETODOLACACTIVE MOIETY2M36281008ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]6
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]6
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]6
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENTZ135WT9208ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]6
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]6
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]6
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]6
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]6
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]6
HYPROMELLOSE 2208 (15000 MPA.S)INACTIVE INGREDIENTZ78RG6M2N2ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]6
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]6
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]6
INDIGOTINDISULFONATE SODIUMINACTIVE INGREDIENTD3741U8K7LETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]6
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]6
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]6
ETODOLACACTIVE INGREDIENT2M36281008ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
ETODOLACACTIVE MOIETY2M36281008ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
ETODOLACACTIVE INGREDIENT2M36281008ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
ETODOLACACTIVE INGREDIENT2M36281008ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
ETODOLACACTIVE MOIETY2M36281008ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
ETODOLACACTIVE MOIETY2M36281008ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENTZ135WT9208ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSE 2208 (15000 MPA.S)INACTIVE INGREDIENTZ78RG6M2N2ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-1122ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA, INC.]13Current NDC, Legacy NDC, 1 package rows20241219_f3bf1675-8fda-40d3-8427-0a6a6133a3d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310245etodolac 400 MG 24HR Extended Release Oral TabletPSNf3bf1675-8fda-40d3-8427-0a6a6133a3d314
359500etodolac 500 MG 24HR Extended Release Oral TabletPSNf3bf1675-8fda-40d3-8427-0a6a6133a3d314
310247etodolac 600 MG 24HR Extended Release Oral TabletPSNf3bf1675-8fda-40d3-8427-0a6a6133a3d314
31024524 HR etodolac 400 MG Extended Release Oral TabletSCDf3bf1675-8fda-40d3-8427-0a6a6133a3d314
35950024 HR etodolac 500 MG Extended Release Oral TabletSCDf3bf1675-8fda-40d3-8427-0a6a6133a3d314
31024724 HR etodolac 600 MG Extended Release Oral TabletSCDf3bf1675-8fda-40d3-8427-0a6a6133a3d314
310245etodolac 400 MG 24 HR Extended Release Oral TabletSYf3bf1675-8fda-40d3-8427-0a6a6133a3d314
359500etodolac 500 MG 24 HR Extended Release Oral TabletSYf3bf1675-8fda-40d3-8427-0a6a6133a3d314
310247etodolac 600 MG 24 HR Extended Release Oral TabletSYf3bf1675-8fda-40d3-8427-0a6a6133a3d314
310245etodolac 400 MG 24HR Extended Release Oral TabletPSNba27e2db-8036-4b69-ae41-eb200f322ad24
31024524 HR etodolac 400 MG Extended Release Oral TabletSCDba27e2db-8036-4b69-ae41-eb200f322ad24
310245etodolac 400 MG 24 HR Extended Release Oral TabletSYba27e2db-8036-4b69-ae41-eb200f322ad24
310245etodolac 400 MG 24HR Extended Release Oral TabletPSN1c49e27f-e028-4d79-b4c7-cb1c46ba8e4d3
310245etodolac 400 MG 24HR Extended Release Oral TabletPSN5a040d8e-8d0c-442f-b4e5-161aa7ccbe9a3
359500etodolac 500 MG 24HR Extended Release Oral TabletPSN1c49e27f-e028-4d79-b4c7-cb1c46ba8e4d3
310247etodolac 600 MG 24HR Extended Release Oral TabletPSN1c49e27f-e028-4d79-b4c7-cb1c46ba8e4d3
31024524 HR etodolac 400 MG Extended Release Oral TabletSCD5a040d8e-8d0c-442f-b4e5-161aa7ccbe9a3
31024524 HR etodolac 400 MG Extended Release Oral TabletSCD1c49e27f-e028-4d79-b4c7-cb1c46ba8e4d3
35950024 HR etodolac 500 MG Extended Release Oral TabletSCD1c49e27f-e028-4d79-b4c7-cb1c46ba8e4d3
31024724 HR etodolac 600 MG Extended Release Oral TabletSCD1c49e27f-e028-4d79-b4c7-cb1c46ba8e4d3
310245etodolac 400 MG 24 HR Extended Release Oral TabletSY5a040d8e-8d0c-442f-b4e5-161aa7ccbe9a3
310245etodolac 400 MG 24 HR Extended Release Oral TabletSY1c49e27f-e028-4d79-b4c7-cb1c46ba8e4d3
359500etodolac 500 MG 24 HR Extended Release Oral TabletSY1c49e27f-e028-4d79-b4c7-cb1c46ba8e4d3
310247etodolac 600 MG 24 HR Extended Release Oral TabletSY1c49e27f-e028-4d79-b4c7-cb1c46ba8e4d3
310245etodolac 400 MG 24HR Extended Release Oral TabletPSN5841e1c3-ee29-4b6c-ac02-7daa82ad63bf2
31024524 HR etodolac 400 MG Extended Release Oral TabletSCD5841e1c3-ee29-4b6c-ac02-7daa82ad63bf2
310245etodolac 400 MG 24 HR Extended Release Oral TabletSY5841e1c3-ee29-4b6c-ac02-7daa82ad63bf2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-1122-0100093112201100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-1122-01) 2001-02-090000-00-00NoNoCurrent