Irbesartan and Hydrochlorothiazide
- Product NDC
- 63187-981
- 11-digit product format
- 631870981
- Labeler code
- 63187
- Product ID
- 63187-981_ae512032-f396-4e77-bce4-409b8844ce3e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Irbesartan and Hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA077369
- Marketing category
- ANDA
- Marketing start
- 2013-01-24
- Substance
- HYDROCHLOROTHIAZIDE; IRBESARTAN
- Active strength
- 12.5; 150 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
- 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 |
|---|---|---|---|---|---|---|---|
| A077369-001 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;150MG | TABLET / ORAL | AB | 2012-03-30 | |
| A077369-002 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;300MG | TABLET / ORAL | AB | 2012-03-30 | |
| A077369-003 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 25MG;300MG | TABLET / ORAL | 2012-03-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077369-001 | AB |
| A077369-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A077369-001 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;150MG | TABLET / ORAL | AB | 2012-03-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A077369-002 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;300MG | TABLET / ORAL | AB | 2012-03-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A077369-003 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 25MG;300MG | TABLET / ORAL | 2012-03-30 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077369-001 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;150MG | TABLET / ORAL | AB | 2012-03-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077369-002 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;300MG | TABLET / ORAL | AB | 2012-03-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077369-003 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 25MG;300MG | TABLET / ORAL | 2012-03-30 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077369-001 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;150MG | TABLET / ORAL | AB | 2012-03-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077369-002 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;300MG | TABLET / ORAL | AB | 2012-03-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077369-003 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 25MG;300MG | TABLET / ORAL | 2012-03-30 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077369-001 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;150MG | TABLET / ORAL | AB | 2012-03-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077369-002 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;300MG | TABLET / ORAL | AB | 2012-03-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077369-003 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 25MG;300MG | TABLET / ORAL | 2012-03-30 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077369-001 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;150MG | TABLET / ORAL | AB | 2012-03-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077369-002 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;300MG | TABLET / ORAL | AB | 2012-03-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077369-003 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 25MG;300MG | TABLET / ORAL | 2012-03-30 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077369-001 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;150MG | TABLET / ORAL | AB | 2012-03-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077369-002 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;300MG | TABLET / ORAL | AB | 2012-03-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077369-003 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 25MG;300MG | TABLET / ORAL | 2012-03-30 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077369-001 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;150MG | TABLET / ORAL | AB | 2012-03-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077369-002 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;300MG | TABLET / ORAL | AB | 2012-03-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077369-003 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 25MG;300MG | TABLET / ORAL | 2012-03-30 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077369-001 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;150MG | TABLET / ORAL | AB | 2012-03-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077369-002 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;300MG | TABLET / ORAL | AB | 2012-03-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077369-003 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 25MG;300MG | TABLET / ORAL | 2012-03-30 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077369-001 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;150MG | TABLET / ORAL | AB | 2012-03-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077369-002 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;300MG | TABLET / ORAL | AB | 2012-03-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077369-003 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 25MG;300MG | TABLET / ORAL | 2012-03-30 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077369-001 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;150MG | TABLET / ORAL | AB | 2012-03-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077369-002 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;300MG | TABLET / ORAL | AB | 2012-03-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077369-003 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 25MG;300MG | TABLET / ORAL | 2012-03-30 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077369-001 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;150MG | TABLET / ORAL | AB | 2012-03-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077369-002 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;300MG | TABLET / ORAL | AB | 2012-03-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077369-003 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 25MG;300MG | TABLET / ORAL | 2012-03-30 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077369-001 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;150MG | TABLET / ORAL | AB | 2012-03-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077369-002 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;300MG | TABLET / ORAL | AB | 2012-03-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077369-003 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 25MG;300MG | TABLET / ORAL | 2012-03-30 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077369-001 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;150MG | TABLET / ORAL | AB | 2012-03-30 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077369-002 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;300MG | TABLET / ORAL | AB | 2012-03-30 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077369-003 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 25MG;300MG | TABLET / ORAL | 2012-03-30 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077369-001 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;150MG | TABLET / ORAL | AB | 2012-03-30 | 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 | A077369-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A077369-002 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A077369-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A077369-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A077369-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077369-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077369-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077369-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077369-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077369-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077369-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077369-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077369-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077369-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077369-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077369-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077369-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077369-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077369-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077369-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077369-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077369-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077369-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077369-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077369-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077369-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077369-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077369-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077369-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077369-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077369-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A077369-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077369-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077369-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A077369-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A077369-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A077369-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A077369-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A077369-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A077369-002 | AB | 1 | 74a2ff9319b5… |
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
- Irbesartan and Hydrochlorothiazide
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| IRBESARTAN | 150 mg/1 |
| HYDROCHLOROTHIAZIDE | 12.5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| J0E2756Z7N | Internal UNII lookup |
| 0J48LPH2TH | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 310792 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| c5f26357-40f3-49f4-99f2-845a8dda5f39 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63187-981-30 | Irbesartan and Hydrochlorothiazide | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 3 | |
| 63187-981-60 | Irbesartan and Hydrochlorothiazide | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 3 | |
| 63187-981-90 | Irbesartan and Hydrochlorothiazide | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 3 |
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 |
|---|---|---|---|---|---|---|
| Irbesartan and Hydrochlorothiazide | IRBESARTAN AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | 5eabb13d-f6fd-4091-9909-c4f0c5922289 | 2026-06-04 | Boxed warning, Warnings, Adverse reactions | 077369 ANDA077369 |
| Irbesartan and Hydrochlorothiazide | IRBESARTAN AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | 5029c9f7-6233-4a6f-ace9-2268cc8e286d | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | 077369 ANDA077369 |
| Irbesartan and Hydrochlorothiazide | IRBESARTAN AND HYDROCHLOROTHIAZIDE | Teva Pharmaceuticals USA, Inc. | 83f4acc1-697a-4770-b554-1b9a8fb5de74 | 2026-01-28 | Boxed warning, Warnings, Adverse reactions | 077369 ANDA077369 |
| Irbesartan and Hydrochlorothiazide | IRBESARTAN AND HYDROCHLOROTHIAZIDE | Proficient Rx LP | c5f26357-40f3-49f4-99f2-845a8dda5f39 | 2019-11-01 | Boxed warning, Warnings, Adverse reactions | 077369 ANDA077369 63187-981 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310792 | irbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet | PSN | c5f26357-40f3-49f4-99f2-845a8dda5f39 | 3 |
| 310792 | hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral Tablet | SCD | c5f26357-40f3-49f4-99f2-845a8dda5f39 | 3 |
| 310792 | HCTZ 12.5 MG / irbesartan 150 MG Oral Tablet | SY | c5f26357-40f3-49f4-99f2-845a8dda5f39 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 63187-981-30 | 63187098130 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-981-30) | 2018-02-01 | 0000-00-00 | No | No | Current |
| 63187-981-60 | 63187098160 | 60 TABLET, FILM COATED in 1 BOTTLE (63187-981-60) | 2018-02-01 | 0000-00-00 | No | No | Current |
| 63187-981-90 | 63187098190 | 90 TABLET, FILM COATED in 1 BOTTLE (63187-981-90) | 2018-02-01 | 0000-00-00 | No | No | Current |