Etodolac
- Product NDC
- 35356-711
- Requested package NDC
- 35356-711-28
- 11-digit product format
- 353560711
- Labeler code
- 35356
- Product ID
- 35356-711_f05681fe-ba95-4b39-bc71-a4c7f4205280
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Etodolac
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
- Application
- ANDA075074
- Marketing category
- ANDA
- Marketing start
- 1998-03-11
- Marketing end
- 0000-00-00
- Substance
- ETODOLAC
- Active strength
- 400 mg/1
- Pharmacologic classes
- Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 35356-711 | 35356-711-28 | D | Discontinued by firm | 2026-08-03 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
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… |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 35356-711-00 | 2021-10-19 | Etodolac Capsules and Tablets, USP |
| 35356-711-14 | 2021-10-19 | Etodolac Capsules and Tablets, USP |
| 35356-711-28 | 2021-10-19 | Etodolac Capsules and Tablets, USP |
| 35356-711-30 | 2021-10-19 | Etodolac Capsules and Tablets, USP |
| 35356-711-40 | 2021-10-19 | Etodolac Capsules and Tablets, USP |
| 35356-711-60 | 2021-10-19 | Etodolac Capsules and Tablets, USP |
| 35356-711-90 | 2021-10-19 | Etodolac Capsules and Tablets, USP |
| 35356-711-00 | 2021-01-29 | Etodolac Capsules and Tablets, USP |
| 35356-711-14 | 2021-01-29 | Etodolac Capsules and Tablets, USP |
| 35356-711-28 | 2021-01-29 | Etodolac Capsules and Tablets, USP |
| 35356-711-30 | 2021-01-29 | Etodolac Capsules and Tablets, USP |
| 35356-711-40 | 2021-01-29 | Etodolac Capsules and Tablets, USP |
| 35356-711-60 | 2021-01-29 | Etodolac Capsules and Tablets, USP |
| 35356-711-90 | 2021-01-29 | Etodolac Capsules and Tablets, USP |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 35356-711-00 | EA - Each | 35356-711 | f8a8b5f1-9b6c-4398-8947-708ad4f94232 | 1 | 2012-07-24 |
| 35356-711-14 | EA - Each | 35356-711 | 34812ff4-ba92-422b-ac61-523608ed05bd | 1 | 2012-07-24 |
| 35356-711-28 | EA - Each | 35356-711 | a1217d09-ac7b-4016-bb47-912621f90980 | 1 | 2013-02-13 |
| 35356-711-30 | EA - Each | 35356-711 | 41724cd3-4f09-469c-bc1a-515197afff49 | 1 | 2012-07-24 |
| 35356-711-60 | EA - Each | 35356-711 | 7173b162-3fe6-4442-aedc-585b99628853 | 1 | 2012-07-24 |
| 35356-711-90 | EA - Each | 35356-711 | a538f494-4d65-484c-8e87-e83ed359c859 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
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 |
| 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 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 35356-711-28 | 35356071128 | 28 TABLET, FILM COATED in 1 BOTTLE (35356-711-28) | 2008-12-01 | 0000-00-00 | No | No | Current |