Etodolac

Product NDC
62559-250
11-digit product format
625590250
Labeler code
62559
Product ID
62559-250_b45612f5-5724-43e1-a1e4-c9f9c0ce5c5b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
CAPSULE
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA075126
Marketing category
ANDA
Marketing start
2015-03-09
Substance
ETODOLAC
Active strength
200 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 42.

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
A075126-001ETODOLACETODOLAC200MGCAPSULE / ORALAB1999-09-16
A075126-002ETODOLACETODOLAC300MGCAPSULE / ORALAB1999-09-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075126-001AB
A075126-002AB

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A075126-001ETODOLAC200MGCAPSULE / ORALAB1999-09-16caaa826d4ba7…
2026-08-18 06:07:402026-07A075126-002ETODOLAC300MGCAPSULE / ORALAB1999-09-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075126-001ETODOLAC200MGCAPSULE / ORALAB1999-09-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075126-002ETODOLAC300MGCAPSULE / ORALAB1999-09-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075126-001ETODOLAC200MGCAPSULE / ORALAB1999-09-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075126-002ETODOLAC300MGCAPSULE / ORALAB1999-09-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A075126-001ETODOLAC200MGCAPSULE / ORALAB1999-09-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075126-002ETODOLAC300MGCAPSULE / ORALAB1999-09-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075126-001ETODOLAC200MGCAPSULE / ORALAB1999-09-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075126-002ETODOLAC300MGCAPSULE / ORALAB1999-09-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075126-001ETODOLAC200MGCAPSULE / ORALAB1999-09-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075126-002ETODOLAC300MGCAPSULE / ORALAB1999-09-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075126-001ETODOLAC200MGCAPSULE / ORALAB1999-09-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075126-002ETODOLAC300MGCAPSULE / ORALAB1999-09-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075126-001ETODOLAC200MGCAPSULE / ORALAB1999-09-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075126-002ETODOLAC300MGCAPSULE / ORALAB1999-09-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075126-001ETODOLAC200MGCAPSULE / ORALAB1999-09-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075126-002ETODOLAC300MGCAPSULE / ORALAB1999-09-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075126-001ETODOLAC200MGCAPSULE / ORALAB1999-09-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075126-002ETODOLAC300MGCAPSULE / ORALAB1999-09-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075126-001ETODOLAC200MGCAPSULE / ORALAB1999-09-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A075126-002ETODOLAC300MGCAPSULE / ORALAB1999-09-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075126-001ETODOLAC200MGCAPSULE / ORALAB1999-09-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075126-002ETODOLAC300MGCAPSULE / ORALAB1999-09-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075126-001ETODOLAC200MGCAPSULE / ORALAB1999-09-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075126-002ETODOLAC300MGCAPSULE / ORALAB1999-09-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075126-001ETODOLAC200MGCAPSULE / ORALAB1999-09-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075126-002ETODOLAC300MGCAPSULE / ORALAB1999-09-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075126-001ETODOLAC200MGCAPSULE / ORALAB1999-09-168072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075126-002ETODOLAC300MGCAPSULE / ORALAB1999-09-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075126-001ETODOLAC200MGCAPSULE / ORALAB1999-09-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075126-002ETODOLAC300MGCAPSULE / ORALAB1999-09-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075126-001ETODOLAC200MGCAPSULE / ORALAB1999-09-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075126-002ETODOLAC300MGCAPSULE / ORALAB1999-09-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075126-001ETODOLAC200MGCAPSULE / ORALAB1999-09-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075126-002ETODOLAC300MGCAPSULE / ORALAB1999-09-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075126-001ETODOLAC200MGCAPSULE / ORALAB1999-09-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075126-002ETODOLAC300MGCAPSULE / ORALAB1999-09-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075126-001ETODOLAC200MGCAPSULE / ORALAB1999-09-16bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075126-002ETODOLAC300MGCAPSULE / ORALAB1999-09-16bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A075126-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075126-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075126-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075126-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075126-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075126-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075126-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075126-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075126-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075126-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075126-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075126-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075126-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075126-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075126-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075126-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075126-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075126-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075126-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075126-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075126-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075126-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075126-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075126-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075126-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075126-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075126-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075126-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075126-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075126-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075126-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075126-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075126-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075126-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075126-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075126-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075126-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075126-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075126-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075126-002AB1bb7c543d1eb4…

Additional Listing Data#

Finished product
Yes
Brand name base
Etodolac
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ETODOLAC200 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 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
420c7b62-3bea-4d6b-82e0-ab1c176c7f1eAvailable 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
24aa5265-325f-0e21-8836-2c9a907c0454Product name220210601

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62559-250-01Etodolac100 in 1 BOTTLECAPSULE10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-250-01EA - Each62559-25087d8a4d5-2a16-4e6c-aabb-40afbcfeff0512015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETODOLACACTIVE INGREDIENT2M36281008ETODOLAC CAPSULE [ANI PHARMACEUTICALS, INC.]3
ETODOLACACTIVE MOIETY2M36281008ETODOLAC CAPSULE [ANI PHARMACEUTICALS, INC.]3
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHETODOLAC CAPSULE [ANI PHARMACEUTICALS, INC.]3
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LETODOLAC CAPSULE [ANI PHARMACEUTICALS, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GETODOLAC CAPSULE [ANI PHARMACEUTICALS, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDETODOLAC CAPSULE [ANI PHARMACEUTICALS, INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAETODOLAC CAPSULE [ANI PHARMACEUTICALS, INC.]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ETODOLAC CAPSULE [ANI PHARMACEUTICALS, INC.]3
GELATININACTIVE INGREDIENT2G86QN327LETODOLAC CAPSULE [ANI PHARMACEUTICALS, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XETODOLAC CAPSULE [ANI PHARMACEUTICALS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ETODOLAC CAPSULE [ANI PHARMACEUTICALS, INC.]3
POVIDONE K25INACTIVE INGREDIENTK0KQV10C35ETODOLAC CAPSULE [ANI PHARMACEUTICALS, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ETODOLAC CAPSULE [ANI PHARMACEUTICALS, INC.]3
SHELLACINACTIVE INGREDIENT46N107B71OETODOLAC CAPSULE [ANI PHARMACEUTICALS, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ETODOLAC CAPSULE [ANI PHARMACEUTICALS, INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JETODOLAC CAPSULE [ANI PHARMACEUTICALS, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ETODOLAC CAPSULE [ANI PHARMACEUTICALS, INC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1UETODOLAC CAPSULE [ANI PHARMACEUTICALS, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPETODOLAC CAPSULE [ANI PHARMACEUTICALS, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-250ETODOLAC CAPSULE [ANI PHARMACEUTICALS, INC.]10Current NDC, Legacy NDC, 1 package rows20240805_420c7b62-3bea-4d6b-82e0-ab1c176c7f1e.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EtodolacETODOLACBryant Ranch Prepack301087e4-f05c-4fd3-8815-c86c6f12ff612026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075126
application number: ANDA075126
EtodolacETODOLACBryant Ranch Prepacka355160d-24c3-4a4d-99ea-84c80ce67f902026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075126
application number: ANDA075126
EtodolacETODOLACBryant Ranch Prepacke7a81661-28a2-40d7-8c90-786629c81e362026-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075126
application number: ANDA075126
EtodolacETODOLACA-S Medication Solutions4d392c1b-95c2-4925-98bf-0203c412d3da2026-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075126
application number: ANDA075126
EtodolacETODOLACANI Pharmaceuticals, Inc.420c7b62-3bea-4d6b-82e0-ab1c176c7f1e2025-12-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075126
application number: ANDA075126
ndc (product): 62559-250
EtodolacETODOLACBryant Ranch Prepackb7f7c4a4-6245-43e1-af40-fcf61abbc64e2024-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075126
application number: ANDA075126
EtodolacETODOLACBryant Ranch Prepackdbaa1202-1ade-4471-96fb-4b951b3862342024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075126
application number: ANDA075126
EtodolacETODOLACProficient Rx LP0fce1aea-5de2-4acb-8a21-2b775c4adb252023-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075126
application number: ANDA075126

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197684etodolac 200 MG Oral CapsulePSNdbaa1202-1ade-4471-96fb-4b951b386234106
197684etodolac 200 MG Oral CapsuleSCDdbaa1202-1ade-4471-96fb-4b951b386234106
197684etodolac 200 MG Oral CapsulePSN301087e4-f05c-4fd3-8815-c86c6f12ff61103
197684etodolac 200 MG Oral CapsuleSCD301087e4-f05c-4fd3-8815-c86c6f12ff61103
197684etodolac 200 MG Oral CapsulePSN420c7b62-3bea-4d6b-82e0-ab1c176c7f1e11
197685etodolac 300 MG Oral CapsulePSN420c7b62-3bea-4d6b-82e0-ab1c176c7f1e11
197684etodolac 200 MG Oral CapsuleSCD420c7b62-3bea-4d6b-82e0-ab1c176c7f1e11
197685etodolac 300 MG Oral CapsuleSCD420c7b62-3bea-4d6b-82e0-ab1c176c7f1e11
197684etodolac 200 MG Oral CapsulePSNe7a81661-28a2-40d7-8c90-786629c81e366
197684etodolac 200 MG Oral CapsuleSCDe7a81661-28a2-40d7-8c90-786629c81e366
197684etodolac 200 MG Oral CapsulePSN0fce1aea-5de2-4acb-8a21-2b775c4adb251
197684etodolac 200 MG Oral CapsuleSCD0fce1aea-5de2-4acb-8a21-2b775c4adb251

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62559-250-0162559025001100 CAPSULE in 1 BOTTLE (62559-250-01) 100 capsule2015-03-090000-00-00NoNoCurrent