Etodolac

Product NDC
51672-4036
11-digit product format
516724036
Labeler code
51672
Product ID
51672-4036_24c2f8e4-51a1-3b14-e063-6394a90ae2af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Taro Pharmaceuticals U.S.A., Inc.
Application
ANDA075074
Marketing category
ANDA
Marketing start
2000-04-25
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075074-001ETODOLACETODOLAC400MGTABLET / ORALAB1998-03-11
A075074-002ETODOLACETODOLAC500MGTABLET / ORALABRS2000-04-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A075074-001AB
A075074-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075074-001ETODOLAC400MGTABLET / ORALAB1998-03-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075074-002ETODOLAC500MGTABLET / ORALABRS2000-04-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075074-001ETODOLAC400MGTABLET / ORALAB1998-03-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075074-002ETODOLAC500MGTABLET / ORALABRS2000-04-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A075074-001ETODOLAC400MGTABLET / ORALAB1998-03-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075074-002ETODOLAC500MGTABLET / ORALABRS2000-04-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075074-001ETODOLAC400MGTABLET / ORALAB1998-03-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075074-002ETODOLAC500MGTABLET / ORALABRS2000-04-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075074-001ETODOLAC400MGTABLET / ORALAB1998-03-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075074-002ETODOLAC500MGTABLET / ORALABRS2000-04-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075074-001ETODOLAC400MGTABLET / ORALAB1998-03-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075074-002ETODOLAC500MGTABLET / ORALABRS2000-04-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075074-001ETODOLAC400MGTABLET / ORALAB1998-03-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075074-002ETODOLAC500MGTABLET / ORALABRS2000-04-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075074-001ETODOLAC400MGTABLET / ORALAB1998-03-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075074-002ETODOLAC500MGTABLET / ORALABRS2000-04-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075074-001ETODOLAC400MGTABLET / ORALAB1998-03-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075074-002ETODOLAC500MGTABLET / ORALABRS2000-04-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075074-001ETODOLAC400MGTABLET / ORALAB1998-03-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A075074-002ETODOLAC500MGTABLET / ORALABRS2000-04-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075074-001ETODOLAC400MGTABLET / ORALAB1998-03-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075074-002ETODOLAC500MGTABLET / ORALABRS2000-04-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075074-001ETODOLAC400MGTABLET / ORALAB1998-03-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075074-002ETODOLAC500MGTABLET / ORALABRS2000-04-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075074-001ETODOLAC400MGTABLET / ORALAB1998-03-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075074-002ETODOLAC500MGTABLET / ORALABRS2000-04-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075074-001ETODOLAC400MGTABLET / ORALAB1998-03-118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075074-002ETODOLAC500MGTABLET / ORALABRS2000-04-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075074-001ETODOLAC400MGTABLET / ORALAB1998-03-115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075074-002ETODOLAC500MGTABLET / ORALABRS2000-04-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075074-001ETODOLAC400MGTABLET / ORALAB1998-03-115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075074-002ETODOLAC500MGTABLET / ORALABRS2000-04-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075074-001ETODOLAC400MGTABLET / ORALAB1998-03-114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075074-002ETODOLAC500MGTABLET / ORALABRS2000-04-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075074-001ETODOLAC400MGTABLET / ORALAB1998-03-1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075074-002ETODOLAC500MGTABLET / ORALABRS2000-04-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075074-001ETODOLAC400MGTABLET / ORALAB1998-03-11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075074-002ETODOLAC500MGTABLET / ORALABRS2000-04-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075074-001ETODOLAC400MGTABLET / ORALAB1998-03-11782e0a99824c…
2021-12-28 21:50 UTC2021-12A075074-002ETODOLAC500MGTABLET / ORALABRS2000-04-25782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A075074-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075074-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075074-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075074-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075074-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075074-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075074-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075074-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075074-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075074-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075074-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075074-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075074-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075074-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075074-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075074-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075074-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075074-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075074-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075074-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075074-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075074-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075074-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075074-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075074-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075074-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075074-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075074-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075074-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075074-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075074-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075074-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075074-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075074-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075074-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075074-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075074-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075074-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075074-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A075074-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Etodolac
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ETODOLAC500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2M36281008Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197684Internal RxNorm lookup
197685Internal RxNorm lookup
197686Internal RxNorm lookup
199390Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ec82b108-6a6f-4d1b-82cb-831d4ed36c80Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bb9faa76-10d1-4b5f-ab9b-d6a26495edb7Product name120250311
0c3d95a8-02c3-425e-810b-2a14408d9a06Product name420250218
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
24aa5265-325f-0e21-8836-2c9a907c0454Product name220210601

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-4036-1Etodolac100 in 1 BOTTLETABLET, FILM COATED1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4036-1EA - Each51672-40360fa55545-3673-46ae-88f7-c7a2cf0fdb9f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EtodolacACTIVE INGREDIENT2M36281008ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.]4
EtodolacACTIVE MOIETY2M36281008ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.]4
AlcoholINACTIVE INGREDIENT3K9958V90METODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.]4
Aluminum OxideINACTIVE INGREDIENTLMI26O6933ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.]4
AmmoniaINACTIVE INGREDIENT5138Q19F1XETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.]4
Butyl AlcoholINACTIVE INGREDIENT8PJ61P6TS3ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.]4
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.]4
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.]4
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.]4
FD&C Red No. 3INACTIVE INGREDIENTPN2ZH5LOQYETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.]4
Ferric Oxide RedINACTIVE INGREDIENT1K09F3G675ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.]4
Ferric Oxide YellowINACTIVE INGREDIENTEX438O2MRTETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.]4
Ferrosoferric OxideINACTIVE INGREDIENTXM0M87F357ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.]4
GelatinINACTIVE INGREDIENT2G86QN327LETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.]4
HypromellosesINACTIVE INGREDIENT3NXW29V3WOETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.]4
Isopropyl AlcoholINACTIVE INGREDIENTND2M416302ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.]4
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.]4
Magnesium StearateINACTIVE INGREDIENT70097M6I30ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.]4
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1AETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.]4
PovidonesINACTIVE INGREDIENTFZ989GH94EETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.]4
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.]4
ShellacINACTIVE INGREDIENT46N107B71OETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.]4
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.]4
Sodium Starch Glycolate Type A PotatoINACTIVE INGREDIENT5856J3G2A2ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.]4
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.]4
WaterINACTIVE INGREDIENT059QF0KO0RETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.]4
EtodolacACTIVE INGREDIENT2M36281008ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]3
EtodolacACTIVE MOIETY2M36281008ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]3
ALCOHOLINACTIVE INGREDIENT3K9958V90METODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]3
AMMONIAINACTIVE INGREDIENT5138Q19F1XETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]3
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]3
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]3
GelatinINACTIVE INGREDIENT2G86QN327LETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]3
Isopropyl AlcoholINACTIVE INGREDIENTND2M416302ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]3
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]3
Magnesium StearateINACTIVE INGREDIENT70097M6I30ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]3
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]3
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]3
PovidoneINACTIVE INGREDIENTFZ989GH94EETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]3
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]3
SHELLACINACTIVE INGREDIENT46N107B71OETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]3
SODIUM STARCH GLYCOLATE TYPE B POTATOINACTIVE INGREDIENT27NA468985ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]3
TRIACETININACTIVE INGREDIENTXHX3C3X673ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]3
WaterINACTIVE INGREDIENT059QF0KO0RETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]3
ETODOLACACTIVE INGREDIENT2M36281008ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
ETODOLACACTIVE MOIETY2M36281008ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90METODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
SHELLACINACTIVE INGREDIENT46N107B71OETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
ETODOLACACTIVE INGREDIENT2M36281008ETODOLAC TABLET [NORTHWIND PHARMACEUTICALS, LLC]1
ETODOLACACTIVE MOIETY2M36281008ETODOLAC TABLET [NORTHWIND PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4036ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.]9Current NDC, Legacy NDC, 1 package rows20241020_ec82b108-6a6f-4d1b-82cb-831d4ed36c80.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EtodolacETODOLACSun Pharmaceutical Industries, Inc.ec82b108-6a6f-4d1b-82cb-831d4ed36c802026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075074
application number: ANDA075074
ndc (product): 51672-4036
EtodolacETODOLACPreferred Pharmaceuticals Inc.117b3005-a8ec-4f76-824c-95ec42dc87a12026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075074
application number: ANDA075074
EtodolacETODOLACBryant Ranch Prepack03458123-e27c-4447-9ef3-3bd32481cb972026-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075074
application number: ANDA075074
EtodolacETODOLACREMEDYREPACK INC.188cdd2e-4196-458c-9631-4fa9a0d309b82025-12-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075074
application number: ANDA075074
EtodolacETODOLACAdvanced Rx of Tennessee, LLC3d865ff0-fc45-1e95-e063-6294a90a8e182025-08-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075074
application number: ANDA075074
EtodolacETODOLACA-S Medication Solutionsa7d91fcf-7928-4c9e-862b-6922d6e47c9d2025-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075074
application number: ANDA075074
EtodolacETODOLACGolden State Medical Supply, Inc.cf17926c-ed90-4fd0-80af-ccee084075e82024-11-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075074
application number: ANDA075074
EtodolacETODOLACAphena Pharma Solutions - Tennessee, LLC2425aef0-57eb-d1a5-e063-6294a90a0bf22024-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075074
application number: ANDA075074
EtodolacETODOLACAphena Pharma Solutions - Tennessee, LLC1547f132-0d35-45cb-e063-6294a90a2efe2024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075074
application number: ANDA075074
EtodolacETODOLACAphena Pharma Solutions - Tennessee, LLC1149072a-280a-2b11-e063-6394a90ac1072024-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075074
application number: ANDA075074
EtodolacETODOLACAphena Pharma Solutions - Tennessee, LLC420b1ed5-e9f2-43dd-8d3c-ca9896221aca2024-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075074
application number: ANDA075074

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197686etodolac 400 MG Oral TabletPSNa7d91fcf-7928-4c9e-862b-6922d6e47c9d13
199390etodolac 500 MG Oral TabletPSNa7d91fcf-7928-4c9e-862b-6922d6e47c9d13
197686etodolac 400 MG Oral TabletSCDa7d91fcf-7928-4c9e-862b-6922d6e47c9d13
199390etodolac 500 MG Oral TabletSCDa7d91fcf-7928-4c9e-862b-6922d6e47c9d13
197684etodolac 200 MG Oral CapsulePSNcf17926c-ed90-4fd0-80af-ccee084075e811
197685etodolac 300 MG Oral CapsulePSNcf17926c-ed90-4fd0-80af-ccee084075e811
197686etodolac 400 MG Oral TabletPSNcf17926c-ed90-4fd0-80af-ccee084075e811
199390etodolac 500 MG Oral TabletPSNcf17926c-ed90-4fd0-80af-ccee084075e811
197684etodolac 200 MG Oral CapsuleSCDcf17926c-ed90-4fd0-80af-ccee084075e811
197685etodolac 300 MG Oral CapsuleSCDcf17926c-ed90-4fd0-80af-ccee084075e811
197686etodolac 400 MG Oral TabletSCDcf17926c-ed90-4fd0-80af-ccee084075e811
199390etodolac 500 MG Oral TabletSCDcf17926c-ed90-4fd0-80af-ccee084075e811
197684etodolac 200 MG Oral CapsulePSNec82b108-6a6f-4d1b-82cb-831d4ed36c809
197685etodolac 300 MG Oral CapsulePSNec82b108-6a6f-4d1b-82cb-831d4ed36c809
197686etodolac 400 MG Oral TabletPSNec82b108-6a6f-4d1b-82cb-831d4ed36c809
199390etodolac 500 MG Oral TabletPSNec82b108-6a6f-4d1b-82cb-831d4ed36c809
197684etodolac 200 MG Oral CapsuleSCDec82b108-6a6f-4d1b-82cb-831d4ed36c809
197685etodolac 300 MG Oral CapsuleSCDec82b108-6a6f-4d1b-82cb-831d4ed36c809
197686etodolac 400 MG Oral TabletSCDec82b108-6a6f-4d1b-82cb-831d4ed36c809
199390etodolac 500 MG Oral TabletSCDec82b108-6a6f-4d1b-82cb-831d4ed36c809
199390etodolac 500 MG Oral TabletPSN188cdd2e-4196-458c-9631-4fa9a0d309b83
199390etodolac 500 MG Oral TabletSCD188cdd2e-4196-458c-9631-4fa9a0d309b83
197684etodolac 200 MG Oral CapsulePSN4b5513c3-b57f-46f1-9855-dad1063aa4c92
197685etodolac 300 MG Oral CapsulePSN4b5513c3-b57f-46f1-9855-dad1063aa4c92
197686etodolac 400 MG Oral TabletPSN4b5513c3-b57f-46f1-9855-dad1063aa4c92
199390etodolac 500 MG Oral TabletPSN4b5513c3-b57f-46f1-9855-dad1063aa4c92
199390etodolac 500 MG Oral TabletPSN1149072a-280a-2b11-e063-6394a90ac1072
197684etodolac 200 MG Oral CapsuleSCD4b5513c3-b57f-46f1-9855-dad1063aa4c92
197685etodolac 300 MG Oral CapsuleSCD4b5513c3-b57f-46f1-9855-dad1063aa4c92
197686etodolac 400 MG Oral TabletSCD4b5513c3-b57f-46f1-9855-dad1063aa4c92
199390etodolac 500 MG Oral TabletSCD1149072a-280a-2b11-e063-6394a90ac1072
199390etodolac 500 MG Oral TabletSCD4b5513c3-b57f-46f1-9855-dad1063aa4c92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51672-4036-151672403601100 TABLET, FILM COATED in 1 BOTTLE (51672-4036-1) 2000-04-250000-00-00NoNoCurrent