Telmisartan and Hydrochlorothiazide
- Product NDC
- 42291-463
- 11-digit product format
- 422910463
- Labeler code
- 42291
- Product ID
- 42291-463_5afb1a80-6024-d7fa-e063-6394a90a7ca2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Telmisartan and Hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA202544
- Marketing category
- ANDA
- Marketing start
- 2024-06-18
- Substance
- TELMISARTAN; HYDROCHLOROTHIAZIDE
- Active strength
- 80; 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 |
|---|---|---|---|---|---|---|---|
| A202544-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 12.5MG;40MG | TABLET / ORAL | AB | 2019-03-04 | |
| A202544-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 12.5MG;80MG | TABLET / ORAL | AB | 2019-03-04 | |
| A202544-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 25MG;80MG | TABLET / ORAL | AB | 2019-03-04 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202544-001 | AB |
| A202544-002 | AB |
| A202544-003 | 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 | A202544-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2019-03-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A202544-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2019-03-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A202544-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | AB | 2019-03-04 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A202544-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2019-03-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202544-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2019-03-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202544-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | AB | 2019-03-04 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202544-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2019-03-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202544-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2019-03-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202544-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | AB | 2019-03-04 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202544-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2019-03-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202544-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2019-03-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202544-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | AB | 2019-03-04 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202544-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2019-03-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202544-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2019-03-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202544-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | AB | 2019-03-04 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202544-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2019-03-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202544-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2019-03-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202544-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | AB | 2019-03-04 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202544-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2019-03-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202544-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2019-03-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202544-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | AB | 2019-03-04 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202544-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2019-03-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202544-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2019-03-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202544-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | AB | 2019-03-04 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202544-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2019-03-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202544-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2019-03-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202544-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | AB | 2019-03-04 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202544-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2019-03-04 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202544-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2019-03-04 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202544-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | AB | 2019-03-04 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202544-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2019-03-04 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202544-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2019-03-04 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202544-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | AB | 2019-03-04 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202544-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2019-03-04 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202544-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2019-03-04 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202544-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | AB | 2019-03-04 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202544-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2019-03-04 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202544-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2019-03-04 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202544-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | AB | 2019-03-04 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202544-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2019-03-04 | 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 | A202544-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A202544-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A202544-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A202544-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202544-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202544-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A202544-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202544-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202544-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202544-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202544-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202544-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202544-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202544-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202544-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202544-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202544-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202544-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202544-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202544-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202544-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202544-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202544-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202544-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202544-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202544-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202544-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202544-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202544-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202544-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202544-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202544-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202544-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A202544-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202544-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202544-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202544-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202544-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202544-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202544-001 | 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
- Telmisartan and Hydrochlorothiazide
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TELMISARTAN | 80 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 |
|---|---|
| 1b303136-dccd-178b-e063-6394a90a35f8 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42291-463-11 | Telmisartan and Hydrochlorothiazide | 10 in 1 BLISTER PACK | TABLET | 10 | 2 | |
| 42291-463-30 | Telmisartan and Hydrochlorothiazide | 3 in 1 BOX | TABLET | 3 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 42291-463-11 | EA - Each | 42291-463 | 130906f0-3ac1-4cec-811b-6c273b794127 | 1 | 2024-07-12 |
| 42291-463-30 | EA - Each | 42291-463 | 92fe3cbe-daa7-4312-830f-b5a7da9fb17f | 1 | 2024-07-12 |
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 | AvKARE | 1b303136-dccd-178b-e063-6394a90a35f8 | 2026-09-08 | Boxed warning, Warnings, Adverse reactions | 202544 ANDA202544 42291-463 |
| Telmisartan and Hydrochlorothiazide | TELMISARTAN AND HYDROCHLOROTHIAZIDE | Glenmark Pharmaceuticals Inc., USA | 1e55800d-f77c-4950-a6d7-2055f4c7ea17 | 2026-01-07 | Boxed warning, Warnings, Adverse reactions | 202544 ANDA202544 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 283316 | telmisartan 40 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet | PSN | 1b303136-dccd-178b-e063-6394a90a35f8 | 2 |
| 283317 | telmisartan 80 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet | PSN | 1b303136-dccd-178b-e063-6394a90a35f8 | 2 |
| 477130 | telmisartan 80 MG / hydroCHLOROthiazide 25 MG Oral Tablet | PSN | 1b303136-dccd-178b-e063-6394a90a35f8 | 2 |
| 283316 | hydrochlorothiazide 12.5 MG / telmisartan 40 MG Oral Tablet | SCD | 1b303136-dccd-178b-e063-6394a90a35f8 | 2 |
| 283317 | hydrochlorothiazide 12.5 MG / telmisartan 80 MG Oral Tablet | SCD | 1b303136-dccd-178b-e063-6394a90a35f8 | 2 |
| 477130 | hydrochlorothiazide 25 MG / telmisartan 80 MG Oral Tablet | SCD | 1b303136-dccd-178b-e063-6394a90a35f8 | 2 |
| 283316 | HCTZ 12.5 MG / telmisartan 40 MG Oral Tablet | SY | 1b303136-dccd-178b-e063-6394a90a35f8 | 2 |
| 283317 | HCTZ 12.5 MG / telmisartan 80 MG Oral Tablet | SY | 1b303136-dccd-178b-e063-6394a90a35f8 | 2 |
| 477130 | HCTZ 25 MG / telmisartan 80 MG Oral Tablet | SY | 1b303136-dccd-178b-e063-6394a90a35f8 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 42291-463-11 | 42291046311 | 10 in 1 BLISTER PACK | Historical | ||||
| 42291-463-30 | 42291046330 | 3 BLISTER PACK in 1 BOX (42291-463-30) / 10 TABLET in 1 BLISTER PACK (42291-463-11) | 3 blister pack | 2024-06-18 | No | No | Current |