olmesartan medoxomil-hydrochlorothiazide
- Product NDC
- 42291-926
- Requested package NDC
- 42291-926-90
- 11-digit product format
- 422910926
- Labeler code
- 42291
- Product ID
- 42291-926_48bfa982-5678-139d-e063-6294a90adbfa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- olmesartan medoxomil-hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- AvKARE
- Application
- NDA021532
- Marketing category
- NDA
- Marketing start
- 2023-07-27
- Substance
- OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE
- Active strength
- 40; 25 mg/1; mg/1
- Pharmacologic classes
- Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021532-002 | BENICAR HCT | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;20MG | TABLET / ORAL | AB | RLD | 2003-06-05 |
| N021532-003 | BENICAR HCT | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;40MG | TABLET / ORAL | AB | RLD | 2003-06-05 |
| N021532-005 | BENICAR HCT | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 25MG;40MG | TABLET / ORAL | AB | RLD, RS | 2003-06-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021532-002 | AB |
| N021532-003 | AB |
| N021532-005 | 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 | N021532-002 | BENICAR HCT | 12.5MG;20MG | TABLET / ORAL | AB | RLD | 2003-06-05 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021532-003 | BENICAR HCT | 12.5MG;40MG | TABLET / ORAL | AB | RLD | 2003-06-05 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021532-005 | BENICAR HCT | 25MG;40MG | TABLET / ORAL | AB | RLD, RS | 2003-06-05 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N021532-002 | BENICAR HCT | 12.5MG;20MG | TABLET / ORAL | AB | RLD | 2003-06-05 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021532-003 | BENICAR HCT | 12.5MG;40MG | TABLET / ORAL | AB | RLD | 2003-06-05 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021532-005 | BENICAR HCT | 25MG;40MG | TABLET / ORAL | AB | RLD, RS | 2003-06-05 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N021532-002 | BENICAR HCT | 12.5MG;20MG | TABLET / ORAL | AB | RLD | 2003-06-05 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021532-003 | BENICAR HCT | 12.5MG;40MG | TABLET / ORAL | AB | RLD | 2003-06-05 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021532-005 | BENICAR HCT | 25MG;40MG | TABLET / ORAL | AB | RLD, RS | 2003-06-05 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021532-002 | BENICAR HCT | 12.5MG;20MG | TABLET / ORAL | AB | RLD | 2003-06-05 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021532-003 | BENICAR HCT | 12.5MG;40MG | TABLET / ORAL | AB | RLD | 2003-06-05 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021532-005 | BENICAR HCT | 25MG;40MG | TABLET / ORAL | AB | RLD, RS | 2003-06-05 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021532-002 | BENICAR HCT | 12.5MG;20MG | TABLET / ORAL | AB | RLD | 2003-06-05 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021532-003 | BENICAR HCT | 12.5MG;40MG | TABLET / ORAL | AB | RLD | 2003-06-05 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021532-005 | BENICAR HCT | 25MG;40MG | TABLET / ORAL | AB | RLD, RS | 2003-06-05 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021532-002 | BENICAR HCT | 12.5MG;20MG | TABLET / ORAL | AB | RLD | 2003-06-05 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021532-003 | BENICAR HCT | 12.5MG;40MG | TABLET / ORAL | AB | RLD | 2003-06-05 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021532-005 | BENICAR HCT | 25MG;40MG | TABLET / ORAL | AB | RLD, RS | 2003-06-05 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021532-002 | BENICAR HCT | 12.5MG;20MG | TABLET / ORAL | AB | RLD | 2003-06-05 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021532-003 | BENICAR HCT | 12.5MG;40MG | TABLET / ORAL | AB | RLD | 2003-06-05 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021532-005 | BENICAR HCT | 25MG;40MG | TABLET / ORAL | AB | RLD, RS | 2003-06-05 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021532-002 | BENICAR HCT | 12.5MG;20MG | TABLET / ORAL | AB | RLD | 2003-06-05 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021532-003 | BENICAR HCT | 12.5MG;40MG | TABLET / ORAL | AB | RLD | 2003-06-05 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021532-005 | BENICAR HCT | 25MG;40MG | TABLET / ORAL | AB | RLD, RS | 2003-06-05 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021532-002 | BENICAR HCT | 12.5MG;20MG | TABLET / ORAL | AB | RLD | 2003-06-05 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021532-003 | BENICAR HCT | 12.5MG;40MG | TABLET / ORAL | AB | RLD | 2003-06-05 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021532-005 | BENICAR HCT | 25MG;40MG | TABLET / ORAL | AB | RLD, RS | 2003-06-05 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021532-002 | BENICAR HCT | 12.5MG;20MG | TABLET / ORAL | AB | RLD | 2003-06-05 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021532-003 | BENICAR HCT | 12.5MG;40MG | TABLET / ORAL | AB | RLD | 2003-06-05 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021532-005 | BENICAR HCT | 25MG;40MG | TABLET / ORAL | AB | RLD, RS | 2003-06-05 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021532-002 | BENICAR HCT | 12.5MG;20MG | TABLET / ORAL | AB | RLD | 2003-06-05 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021532-003 | BENICAR HCT | 12.5MG;40MG | TABLET / ORAL | AB | RLD | 2003-06-05 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021532-005 | BENICAR HCT | 25MG;40MG | TABLET / ORAL | AB | RLD, RS | 2003-06-05 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021532-002 | BENICAR HCT | 12.5MG;20MG | TABLET / ORAL | AB | RLD | 2003-06-05 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021532-003 | BENICAR HCT | 12.5MG;40MG | TABLET / ORAL | AB | RLD | 2003-06-05 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021532-005 | BENICAR HCT | 25MG;40MG | TABLET / ORAL | AB | RLD, RS | 2003-06-05 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021532-002 | BENICAR HCT | 12.5MG;20MG | TABLET / ORAL | AB | RLD | 2003-06-05 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021532-003 | BENICAR HCT | 12.5MG;40MG | TABLET / ORAL | AB | RLD | 2003-06-05 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021532-005 | BENICAR HCT | 25MG;40MG | TABLET / ORAL | AB | RLD, RS | 2003-06-05 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021532-002 | BENICAR HCT | 12.5MG;20MG | TABLET / ORAL | AB | RLD | 2003-06-05 | 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 | N021532-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021532-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021532-005 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N021532-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021532-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021532-005 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N021532-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021532-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021532-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021532-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021532-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021532-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021532-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021532-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021532-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021532-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021532-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021532-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021532-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021532-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021532-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021532-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021532-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021532-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021532-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021532-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021532-005 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021532-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021532-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021532-005 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021532-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021532-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021532-005 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021532-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021532-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021532-005 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021532-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021532-003 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021532-005 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021532-002 | AB | 1 | 301d65b070ca… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- olmesartan medoxomil-hydrochlorothiazide
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OLMESARTAN MEDOXOMIL | 40 mg/1 |
| HYDROCHLOROTHIAZIDE | 25 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 6M97XTV3HD | Internal UNII lookup |
| 0J48LPH2TH | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 017bc6a3-5b3d-2381-e063-6394a90abece | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 42291-926-90 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1f91-111a-e063-dadaa90a10e2 | Olmesartan Medoxomil and Hydrochlorothiazide Tablets Rx Only These highlights do not include all the information needed to use Olmesartan Medoxomil and Hydrochlorothiazide safely and effectively. See full prescribing information for Olmesartan Medoxomil and Hydrochlorothiazide. Initial U.S. Approval: 2003 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42291-926-90 | olmesartan medoxomil-hydrochlorothiazide | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 42291-926-90 | EA - Each | 42291-926 | 189d07ca-c2a5-4bba-89d5-59ad534112fb | 1 | 2023-09-05 |
DailyMed Dashboard NDC Coverage#
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-hydrochlorothiazide | OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE | AvKARE | 569596a2-98f0-116a-e063-6294a90a3fa1 | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | 021532 NDA021532 |
| Benicar HCT | OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE | Cosette Pharmaceuticals, Inc. | a90915ca-f9d3-4fff-8370-d5dc4cdfc521 | 2026-03-10 | Boxed warning, Warnings, Adverse reactions | 021532 NDA021532 |
| olmesartan medoxomil-hydrochlorothiazide | OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE | AvKARE | 017bc6a3-5b3d-2381-e063-6394a90abece | 2026-01-19 | Boxed warning, Warnings, Adverse reactions | 021532 NDA021532 42291-926-90 42291-926 42291092690 |
| Benicar HCT | OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE | Cosette Pharmaceuticals, Inc. | 881a1c32-c209-4038-9c5e-c5e46c6e0546 | 2023-07-12 | Boxed warning, Warnings, Adverse reactions | 021532 NDA021532 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 403853 | olmesartan medoxomil 20 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet | PSN | 017bc6a3-5b3d-2381-e063-6394a90abece | 3 |
| 403854 | olmesartan medoxomil 40 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet | PSN | 017bc6a3-5b3d-2381-e063-6394a90abece | 3 |
| 403855 | olmesartan medoxomil 40 MG / hydroCHLOROthiazide 25 MG Oral Tablet | PSN | 017bc6a3-5b3d-2381-e063-6394a90abece | 3 |
| 403853 | hydrochlorothiazide 12.5 MG / olmesartan medoxomil 20 MG Oral Tablet | SCD | 017bc6a3-5b3d-2381-e063-6394a90abece | 3 |
| 403854 | hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral Tablet | SCD | 017bc6a3-5b3d-2381-e063-6394a90abece | 3 |
| 403855 | hydrochlorothiazide 25 MG / olmesartan medoxomil 40 MG Oral Tablet | SCD | 017bc6a3-5b3d-2381-e063-6394a90abece | 3 |
| 403853 | HCTZ 12.5 MG / olmesartan medoxomil 20 MG Oral Tablet | SY | 017bc6a3-5b3d-2381-e063-6394a90abece | 3 |
| 403854 | HCTZ 12.5 MG / olmesartan medoxomil 40 MG Oral Tablet | SY | 017bc6a3-5b3d-2381-e063-6394a90abece | 3 |
| 403855 | HCTZ 25 MG / olmesartan medoxomil 40 MG Oral Tablet | SY | 017bc6a3-5b3d-2381-e063-6394a90abece | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 42291-926-90 | 42291092690 | 90 TABLET, FILM COATED in 1 BOTTLE (42291-926-90) | 2023-07-27 | No | No | Current |