TELMISARTAN AND HYDROCHLOROTHIAZIDE
- Product NDC
- 43547-441
- 11-digit product format
- 435470441
- Labeler code
- 43547
- Product ID
- 43547-441_a7294951-f71f-442b-9f8e-2551963db085
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- telmisartan and hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Solco Healthcare LLC
- Application
- ANDA209028
- Marketing category
- ANDA
- Marketing start
- 2018-02-05
- Substance
- TELMISARTAN; HYDROCHLOROTHIAZIDE
- Active strength
- 40; 12.5 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 |
|---|---|---|---|---|---|---|---|
| A209028-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 12.5MG;40MG | TABLET / ORAL | AB | 2017-11-06 | |
| A209028-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 12.5MG;80MG | TABLET / ORAL | AB | 2017-11-06 | |
| A209028-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 25MG;80MG | TABLET / ORAL | AB | 2017-11-06 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A209028-001 | AB |
| A209028-002 | AB |
| A209028-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A209028-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2017-11-06 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A209028-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2017-11-06 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A209028-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | AB | 2017-11-06 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A209028-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2017-11-06 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A209028-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2017-11-06 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A209028-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | AB | 2017-11-06 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A209028-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2017-11-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209028-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2017-11-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209028-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | AB | 2017-11-06 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209028-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2017-11-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209028-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2017-11-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209028-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | AB | 2017-11-06 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209028-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2017-11-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209028-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2017-11-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209028-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | AB | 2017-11-06 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209028-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2017-11-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209028-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2017-11-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209028-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | AB | 2017-11-06 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209028-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2017-11-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209028-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2017-11-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209028-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | AB | 2017-11-06 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209028-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2017-11-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209028-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2017-11-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209028-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | AB | 2017-11-06 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209028-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2017-11-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209028-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2017-11-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209028-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | AB | 2017-11-06 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209028-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2017-11-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209028-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2017-11-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209028-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | AB | 2017-11-06 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209028-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2017-11-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209028-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2017-11-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209028-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | AB | 2017-11-06 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209028-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2017-11-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209028-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2017-11-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209028-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | AB | 2017-11-06 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A209028-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2017-11-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A209028-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2017-11-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A209028-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | AB | 2017-11-06 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209028-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2017-11-06 | 79d66fd596c7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2020-11-12 02:37 UTC | 2020-11 | A209028-003 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A209028-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A209028-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A209028-003 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A209028-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A209028-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A209028-003 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A209028-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A209028-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A209028-003 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A209028-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A209028-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A209028-003 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A209028-001 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A209028-002 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A209028-003 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A209028-001 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A209028-002 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A209028-003 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A209028-001 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A209028-002 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A209028-003 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A209028-001 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A209028-002 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A209028-003 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A209028-001 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A209028-002 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A209028-003 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A209028-001 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A209028-002 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A209028-003 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A209028-001 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A209028-002 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A209028-003 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A209028-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A209028-002 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A209028-003 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A209028-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A209028-002 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A209028-003 | AB | 1 | 3a93d1ddd44b… |
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
- TELMISARTAN AND HYDROCHLOROTHIAZIDE
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TELMISARTAN | 40 mg/1 |
| HYDROCHLOROTHIAZIDE | 12.5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0J48LPH2TH | Internal UNII lookup |
| U5SYW473RQ | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 47c8eee0-f0b7-4bd8-97e9-0029aa1b37db | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43547-441-03 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 30 in 1 BOTTLE | TABLET | 30 | 6 | |
| 43547-441-09 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 90 in 1 BOTTLE | TABLET | 90 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43547-441-03 | EA - Each | 43547-441 | e15a383a-df8d-484d-af8a-a7dbfc165764 | 1 | 2018-06-11 |
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 |
|---|---|---|---|---|---|---|
| TELMISARTAN AND HYDROCHLOROTHIAZIDE | TELMISARTAN AND HYDROCHLOROTHIAZIDE | Solco Healthcare LLC | 47c8eee0-f0b7-4bd8-97e9-0029aa1b37db | 2025-06-30 | Boxed warning, Warnings, Adverse reactions | 209028 ANDA209028 43547-441 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 283316 | telmisartan 40 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet | PSN | 47c8eee0-f0b7-4bd8-97e9-0029aa1b37db | 6 |
| 283317 | telmisartan 80 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet | PSN | 47c8eee0-f0b7-4bd8-97e9-0029aa1b37db | 6 |
| 477130 | telmisartan 80 MG / hydroCHLOROthiazide 25 MG Oral Tablet | PSN | 47c8eee0-f0b7-4bd8-97e9-0029aa1b37db | 6 |
| 283316 | hydrochlorothiazide 12.5 MG / telmisartan 40 MG Oral Tablet | SCD | 47c8eee0-f0b7-4bd8-97e9-0029aa1b37db | 6 |
| 283317 | hydrochlorothiazide 12.5 MG / telmisartan 80 MG Oral Tablet | SCD | 47c8eee0-f0b7-4bd8-97e9-0029aa1b37db | 6 |
| 477130 | hydrochlorothiazide 25 MG / telmisartan 80 MG Oral Tablet | SCD | 47c8eee0-f0b7-4bd8-97e9-0029aa1b37db | 6 |
| 283316 | HCTZ 12.5 MG / telmisartan 40 MG Oral Tablet | SY | 47c8eee0-f0b7-4bd8-97e9-0029aa1b37db | 6 |
| 283317 | HCTZ 12.5 MG / telmisartan 80 MG Oral Tablet | SY | 47c8eee0-f0b7-4bd8-97e9-0029aa1b37db | 6 |
| 477130 | HCTZ 25 MG / telmisartan 80 MG Oral Tablet | SY | 47c8eee0-f0b7-4bd8-97e9-0029aa1b37db | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 43547-441-03 | 43547044103 | 30 TABLET in 1 BOTTLE (43547-441-03) | 30 tablet | 2018-02-05 | 0000-00-00 | No | No | Current |
| 43547-441-09 | 43547044109 | 90 TABLET in 1 BOTTLE (43547-441-09) | 90 tablet | 2018-02-05 | 0000-00-00 | No | No | Current |