OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE
- Product NDC
- 70518-1347
- 11-digit product format
- 705181347
- Labeler code
- 70518
- Product ID
- 70518-1347_92547f9d-b348-2379-e053-2995a90a198c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- olmesartan medoxomil and hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA207804
- Marketing category
- ANDA
- Marketing start
- 2018-08-06
- Marketing end
- 0000-00-00
- Substance
- OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE
- Active strength
- 40 mg/1; mg/1
- Pharmacologic classes
- Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 product | product | 70518-1347 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 70518-1347 | 70518-1347-0 | D | Discontinued by firm | 2026-10-05 |
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 | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 70518-1347-0 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 70518-1347-0 | f5e01cc5f278… | a2eaf40c39c3… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A207804-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;20MG | TABLET / ORAL | AB | 2017-04-24 | |
| A207804-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;40MG | TABLET / ORAL | AB | 2017-04-24 | |
| A207804-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 25MG;40MG | TABLET / ORAL | AB | 2017-04-24 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A207804-001 | AB |
| A207804-002 | AB |
| A207804-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A207804-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2017-04-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A207804-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2017-04-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A207804-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | AB | 2017-04-24 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A207804-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2017-04-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207804-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2017-04-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207804-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | AB | 2017-04-24 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207804-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2017-04-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207804-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2017-04-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207804-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | AB | 2017-04-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207804-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2017-04-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207804-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2017-04-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207804-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | AB | 2017-04-24 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207804-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2017-04-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207804-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2017-04-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207804-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | AB | 2017-04-24 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207804-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2017-04-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207804-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2017-04-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207804-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | AB | 2017-04-24 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207804-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2017-04-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207804-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2017-04-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207804-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | AB | 2017-04-24 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207804-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2017-04-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207804-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2017-04-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207804-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | AB | 2017-04-24 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207804-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2017-04-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207804-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2017-04-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207804-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | AB | 2017-04-24 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207804-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2017-04-24 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207804-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2017-04-24 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207804-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | AB | 2017-04-24 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207804-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2017-04-24 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207804-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2017-04-24 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207804-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | AB | 2017-04-24 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207804-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2017-04-24 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207804-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2017-04-24 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207804-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | AB | 2017-04-24 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207804-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2017-04-24 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207804-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2017-04-24 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207804-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | AB | 2017-04-24 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207804-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2017-04-24 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A207804-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207804-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207804-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A207804-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A207804-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A207804-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A207804-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207804-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207804-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207804-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207804-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207804-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A207804-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207804-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207804-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207804-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207804-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207804-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207804-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207804-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207804-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207804-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207804-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207804-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207804-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207804-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207804-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207804-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207804-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207804-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207804-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207804-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207804-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A207804-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A207804-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A207804-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207804-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207804-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207804-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207804-001 | AB | 1 | 301d65b070ca… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 |
|---|---|---|---|---|---|---|
| OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | 68d44330-4213-46a7-97b9-f858c16454d1 | 2026-05-12 | Boxed warning, Warnings, Adverse reactions | 207804 ANDA207804 |
| OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | 78eb9041-a738-4056-8705-8c1dd13a4da4 | 2026-05-12 | Boxed warning, Warnings, Adverse reactions | 207804 ANDA207804 |
| OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | 2c8bb018-af07-4745-a4e9-f9a6795a5ea2 | 2026-04-10 | Boxed warning, Warnings, Adverse reactions | 207804 ANDA207804 |
| OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | Solco Healthcare US, LLC | bdca31d3-60b1-4659-aef7-56530b4f9039 | 2025-12-31 | Boxed warning, Warnings, Adverse reactions | 207804 ANDA207804 |
| OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | A-S Medication Solutions | 5c4c5907-36f0-461e-b0c9-d51edff32a97 | 2025-06-19 | Boxed warning, Warnings, Adverse reactions | 207804 ANDA207804 |
| OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | A-S Medication Solutions | 4c0b028d-f0f4-417f-a068-dca24e56113f | 2024-04-10 | Boxed warning, Warnings, Adverse reactions | 207804 ANDA207804 |
| OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | A-S Medication Solutions | 13a03209-c73c-4254-be19-d1f8884cc662 | 2023-11-29 | Boxed warning, Warnings, Adverse reactions | 207804 ANDA207804 |