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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075074-001 | ETODOLAC | ETODOLAC | 400MG | TABLET / ORAL | AB | 1998-03-11 | |
| A075074-002 | ETODOLAC | ETODOLAC | 500MG | TABLET / ORAL | AB | RS | 2000-04-25 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075074-001 | AB |
| A075074-002 | AB |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A075074-001 | ETODOLAC | 400MG | TABLET / ORAL | AB | 1998-03-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075074-002 | ETODOLAC | 500MG | TABLET / ORAL | AB | RS | 2000-04-25 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075074-001 | ETODOLAC | 400MG | TABLET / ORAL | AB | 1998-03-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075074-002 | ETODOLAC | 500MG | TABLET / ORAL | AB | RS | 2000-04-25 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075074-001 | ETODOLAC | 400MG | TABLET / ORAL | AB | 1998-03-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075074-002 | ETODOLAC | 500MG | TABLET / ORAL | AB | RS | 2000-04-25 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075074-001 | ETODOLAC | 400MG | TABLET / ORAL | AB | 1998-03-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075074-002 | ETODOLAC | 500MG | TABLET / ORAL | AB | RS | 2000-04-25 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075074-001 | ETODOLAC | 400MG | TABLET / ORAL | AB | 1998-03-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075074-002 | ETODOLAC | 500MG | TABLET / ORAL | AB | RS | 2000-04-25 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075074-001 | ETODOLAC | 400MG | TABLET / ORAL | AB | 1998-03-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075074-002 | ETODOLAC | 500MG | TABLET / ORAL | AB | RS | 2000-04-25 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075074-001 | ETODOLAC | 400MG | TABLET / ORAL | AB | 1998-03-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075074-002 | ETODOLAC | 500MG | TABLET / ORAL | AB | RS | 2000-04-25 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075074-001 | ETODOLAC | 400MG | TABLET / ORAL | AB | 1998-03-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075074-002 | ETODOLAC | 500MG | TABLET / ORAL | AB | RS | 2000-04-25 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075074-001 | ETODOLAC | 400MG | TABLET / ORAL | AB | 1998-03-11 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075074-002 | ETODOLAC | 500MG | TABLET / ORAL | AB | RS | 2000-04-25 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075074-001 | ETODOLAC | 400MG | TABLET / ORAL | AB | 1998-03-11 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075074-002 | ETODOLAC | 500MG | TABLET / ORAL | AB | RS | 2000-04-25 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075074-001 | ETODOLAC | 400MG | TABLET / ORAL | AB | 1998-03-11 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075074-002 | ETODOLAC | 500MG | TABLET / ORAL | AB | RS | 2000-04-25 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075074-001 | ETODOLAC | 400MG | TABLET / ORAL | AB | 1998-03-11 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075074-002 | ETODOLAC | 500MG | TABLET / ORAL | AB | RS | 2000-04-25 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075074-001 | ETODOLAC | 400MG | TABLET / ORAL | AB | 1998-03-11 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075074-002 | ETODOLAC | 500MG | TABLET / ORAL | AB | RS | 2000-04-25 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A075074-001 | ETODOLAC | 400MG | TABLET / ORAL | AB | 1998-03-11 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A075074-002 | ETODOLAC | 500MG | TABLET / ORAL | AB | RS | 2000-04-25 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075074-001 | ETODOLAC | 400MG | TABLET / ORAL | AB | 1998-03-11 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075074-002 | ETODOLAC | 500MG | TABLET / ORAL | AB | RS | 2000-04-25 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A075074-001 | ETODOLAC | 400MG | TABLET / ORAL | AB | 1998-03-11 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A075074-002 | ETODOLAC | 500MG | TABLET / ORAL | AB | RS | 2000-04-25 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A075074-001 | ETODOLAC | 400MG | TABLET / ORAL | AB | 1998-03-11 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A075074-002 | ETODOLAC | 500MG | TABLET / ORAL | AB | RS | 2000-04-25 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A075074-001 | ETODOLAC | 400MG | TABLET / ORAL | AB | 1998-03-11 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A075074-002 | ETODOLAC | 500MG | TABLET / ORAL | AB | RS | 2000-04-25 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A075074-001 | ETODOLAC | 400MG | TABLET / ORAL | AB | 1998-03-11 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A075074-002 | ETODOLAC | 500MG | TABLET / ORAL | AB | RS | 2000-04-25 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A075074-001 | ETODOLAC | 400MG | TABLET / ORAL | AB | 1998-03-11 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A075074-002 | ETODOLAC | 500MG | TABLET / ORAL | AB | RS | 2000-04-25 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A075074-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075074-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075074-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075074-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075074-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075074-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075074-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075074-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075074-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075074-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075074-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075074-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075074-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075074-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075074-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075074-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075074-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075074-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075074-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075074-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075074-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075074-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075074-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075074-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075074-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075074-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A075074-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A075074-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075074-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075074-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A075074-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A075074-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A075074-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A075074-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A075074-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A075074-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A075074-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A075074-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A075074-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A075074-002 | AB | 1 | 782e0a99824c… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Etodolac
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ETODOLAC | 500 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2M36281008 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ec82b108-6a6f-4d1b-82cb-831d4ed36c80 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bb9faa76-10d1-4b5f-ab9b-d6a26495edb7 | Product name | 1 | 20250311 |
| 0c3d95a8-02c3-425e-810b-2a14408d9a06 | Product name | 4 | 20250218 |
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
| 24aa5265-325f-0e21-8836-2c9a907c0454 | Product name | 2 | 20210601 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51672-4036-1 | Etodolac | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51672-4036-1 | EA - Each | 51672-4036 | 0fa55545-3673-46ae-88f7-c7a2cf0fdb9f | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51672-4036 | ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.] | 9 | Current NDC, Legacy NDC, 1 package rows | 20241020_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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Etodolac | ETODOLAC | Sun Pharmaceutical Industries, Inc. | ec82b108-6a6f-4d1b-82cb-831d4ed36c80 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | 075074 ANDA075074 51672-4036 |
| Etodolac | ETODOLAC | Preferred Pharmaceuticals Inc. | 117b3005-a8ec-4f76-824c-95ec42dc87a1 | 2026-04-14 | Boxed warning, Warnings, Adverse reactions | 075074 ANDA075074 |
| Etodolac | ETODOLAC | Bryant Ranch Prepack | 03458123-e27c-4447-9ef3-3bd32481cb97 | 2026-03-09 | Boxed warning, Warnings, Adverse reactions | 075074 ANDA075074 |
| Etodolac | ETODOLAC | REMEDYREPACK INC. | 188cdd2e-4196-458c-9631-4fa9a0d309b8 | 2025-12-29 | Boxed warning, Warnings, Adverse reactions | 075074 ANDA075074 |
| Etodolac | ETODOLAC | Advanced Rx of Tennessee, LLC | 3d865ff0-fc45-1e95-e063-6294a90a8e18 | 2025-08-29 | Boxed warning, Warnings, Adverse reactions | 075074 ANDA075074 |
| Etodolac | ETODOLAC | A-S Medication Solutions | a7d91fcf-7928-4c9e-862b-6922d6e47c9d | 2025-02-06 | Boxed warning, Warnings, Adverse reactions | 075074 ANDA075074 |
| Etodolac | ETODOLAC | Golden State Medical Supply, Inc. | cf17926c-ed90-4fd0-80af-ccee084075e8 | 2024-11-25 | Boxed warning, Warnings, Adverse reactions | 075074 ANDA075074 |
| Etodolac | ETODOLAC | Aphena Pharma Solutions - Tennessee, LLC | 2425aef0-57eb-d1a5-e063-6294a90a0bf2 | 2024-10-10 | Boxed warning, Warnings, Adverse reactions | 075074 ANDA075074 |
| Etodolac | ETODOLAC | Aphena Pharma Solutions - Tennessee, LLC | 1547f132-0d35-45cb-e063-6294a90a2efe | 2024-04-04 | Boxed warning, Warnings, Adverse reactions | 075074 ANDA075074 |
| Etodolac | ETODOLAC | Aphena Pharma Solutions - Tennessee, LLC | 1149072a-280a-2b11-e063-6394a90ac107 | 2024-02-19 | Boxed warning, Warnings, Adverse reactions | 075074 ANDA075074 |
| Etodolac | ETODOLAC | Aphena Pharma Solutions - Tennessee, LLC | 420b1ed5-e9f2-43dd-8d3c-ca9896221aca | 2024-01-29 | Boxed warning, Warnings, Adverse reactions | 075074 ANDA075074 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 51672-4036-1 | 51672403601 | 100 TABLET, FILM COATED in 1 BOTTLE (51672-4036-1) | 2000-04-25 | 0000-00-00 | No | No | Current |