Triamterene and Hydrochlorothiazide
- Product NDC
- 82804-308
- Requested package NDC
- 82804-308-30
- 11-digit product format
- 828040308
- Labeler code
- 82804
- Product ID
- 82804-308_4bc374e2-8650-41bc-8ce6-92062661bf8a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Triamterene and Hydrochlorothiazide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA208358
- Marketing category
- ANDA
- Marketing start
- 2020-02-21
- Substance
- TRIAMTERENE; HYDROCHLOROTHIAZIDE
- Active strength
- 37.5; 25 mg/1; mg/1
- Pharmacologic classes
- Decreased Renal K+ Excretion [PE], Increased Diuresis [PE], Increased Diuresis [PE], Potassium-sparing Diuretic [EPC], 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 |
|---|---|---|---|---|---|---|---|
| A208358-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | 25MG;37.5MG | CAPSULE / ORAL | AB | 2019-02-11 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A208358-001 | 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 | A208358-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | CAPSULE / ORAL | AB | 2019-02-11 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A208358-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | CAPSULE / ORAL | AB | 2019-02-11 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208358-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | CAPSULE / ORAL | AB | 2019-02-11 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208358-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | CAPSULE / ORAL | AB | 2019-02-11 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208358-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | CAPSULE / ORAL | AB | 2019-02-11 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208358-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | CAPSULE / ORAL | AB | 2019-02-11 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208358-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | CAPSULE / ORAL | AB | 2019-02-11 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208358-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | CAPSULE / ORAL | AB | 2019-02-11 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208358-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | CAPSULE / ORAL | AB | 2019-02-11 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208358-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | CAPSULE / ORAL | AB | 2019-02-11 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208358-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | CAPSULE / ORAL | AB | 2019-02-11 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A208358-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | CAPSULE / ORAL | AB | 2019-02-11 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208358-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | CAPSULE / ORAL | AB | 2019-02-11 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208358-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | CAPSULE / ORAL | AB | 2019-02-11 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208358-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | CAPSULE / ORAL | AB | 2019-02-11 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A208358-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | CAPSULE / ORAL | AB | 2019-02-11 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A208358-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | CAPSULE / ORAL | AB | 2019-02-11 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A208358-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | CAPSULE / ORAL | AB | 2019-02-11 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A208358-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | CAPSULE / ORAL | AB | 2019-02-11 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A208358-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | CAPSULE / ORAL | AB | 2019-02-11 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A208358-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | CAPSULE / ORAL | AB | 2019-02-11 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A208358-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | CAPSULE / ORAL | AB | 2019-02-11 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A208358-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | CAPSULE / ORAL | AB | 2019-02-11 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A208358-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | CAPSULE / ORAL | AB | 2019-02-11 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A208358-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | CAPSULE / ORAL | AB | 2019-02-11 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A208358-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | CAPSULE / ORAL | AB | 2019-02-11 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A208358-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | CAPSULE / ORAL | AB | 2019-02-11 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A208358-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | CAPSULE / ORAL | AB | 2019-02-11 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A208358-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | CAPSULE / ORAL | AB | 2019-02-11 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A208358-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | CAPSULE / ORAL | AB | 2019-02-11 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A208358-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | CAPSULE / ORAL | AB | 2019-02-11 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A208358-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | CAPSULE / ORAL | AB | 2019-02-11 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A208358-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | CAPSULE / ORAL | AB | 2019-02-11 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A208358-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | CAPSULE / ORAL | AB | 2019-02-11 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A208358-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | CAPSULE / ORAL | AB | 2019-02-11 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A208358-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | CAPSULE / ORAL | AB | 2019-02-11 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A208358-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | CAPSULE / ORAL | AB | 2019-02-11 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A208358-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | CAPSULE / ORAL | AB | 2019-02-11 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A208358-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | CAPSULE / ORAL | AB | 2019-02-11 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A208358-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | CAPSULE / ORAL | AB | 2019-02-11 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A208358-001 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A208358-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A208358-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208358-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A208358-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208358-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208358-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208358-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208358-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208358-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208358-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A208358-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208358-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208358-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208358-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A208358-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A208358-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A208358-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A208358-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A208358-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A208358-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A208358-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A208358-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A208358-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A208358-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A208358-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A208358-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A208358-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A208358-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A208358-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A208358-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A208358-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A208358-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A208358-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A208358-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A208358-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A208358-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A208358-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A208358-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A208358-001 | AB | 1 | f41ea6bd6efb… |
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
- Triamterene and Hydrochlorothiazide
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TRIAMTERENE | 37.5 mg/1 |
| HYDROCHLOROTHIAZIDE | 25 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| WS821Z52LQ | Internal UNII lookup |
| 0J48LPH2TH | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 198316 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4bc374e2-8650-41bc-8ce6-92062661bf8a | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| Triamterene and Hydrochlorothiazide | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | REMEDYREPACK INC. | 7dc3414b-dcb5-4b11-bca7-c0fa3f474aea | 2026-09-03 | Boxed warning, Adverse reactions | 208358 ANDA208358 |
| Triamterene and Hydrochlorothiazide | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | Proficient Rx LP | 4bc374e2-8650-41bc-8ce6-92062661bf8a | 2026-07-01 | Boxed warning, Adverse reactions | 208358 ANDA208358 82804-308-30 82804-308 82804030830 |
| Triamterene and Hydrochlorothiazide | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | St. Mary's Medical Park Pharmacy | de5e7c85-5bf5-5b5f-e053-2995a90a1fba | 2026-06-01 | Boxed warning, Adverse reactions | 208358 ANDA208358 |
| Triamterene and Hydrochlorothiazide | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | Northwind Health Company, LLC | 08f3885e-dfde-79e4-e063-6394a90a4c09 | 2025-12-26 | Boxed warning, Adverse reactions | 208358 ANDA208358 |
| Triamterene and Hydrochlorothiazide | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | Preferred Pharmaceuticals Inc. | 1fff8245-2b65-4ab1-aaa2-6bbbc6ac5fe8 | 2025-10-01 | Boxed warning, Adverse reactions | 208358 ANDA208358 |
| Triamterene and Hydrochlorothiazide | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | A-S Medication Solutions | 8857b70b-861d-44f8-a671-78c06c83c029 | 2024-11-08 | Boxed warning, Adverse reactions | 208358 ANDA208358 |
| Triamterene and Hydrochlorothiazide | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | A-S Medication Solutions | d9fe1367-e725-4527-b515-95851d270b18 | 2024-11-08 | Boxed warning, Adverse reactions | 208358 ANDA208358 |
| Triamterene and Hydrochlorothiazide | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | NuCare Pharmaceuticals,Inc. | cba87d5b-9302-7b2c-e053-2a95a90a7f9d | 2024-04-17 | Boxed warning, Adverse reactions | 208358 ANDA208358 |
| Triamterene and Hydrochlorothiazide | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | 5ca13106-f68b-4894-aca2-03e74fff350c | 2024-04-03 | Boxed warning, Adverse reactions | 208358 ANDA208358 |
| Triamterene and Hydrochlorothiazide | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | Viona Pharmaceuticals Inc | 9925ab75-e3b7-43b7-888e-a2c8763240ba | 2023-10-31 | Boxed warning, Adverse reactions | 208358 ANDA208358 |
| Triamterene and Hydrochlorothiazide | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | Zydus Pharmaceuticals (USA) Inc. | ee11db7b-91bd-4231-8783-889d98e4fa32 | 2019-02-23 | Boxed warning, Adverse reactions | 208358 ANDA208358 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 82804-308-30 | 82804030830 | 30 CAPSULE in 1 BOTTLE (82804-308-30) | 30 capsule | 2026-07-31 | No | No | Current |