Losartan Potassium and Hydrochlorothiazide
- Product NDC
- 68788-9461
- 11-digit product format
- 687889461
- Labeler code
- 68788
- Product ID
- 68788-9461_5f6cae21-74a4-47a6-8bf4-ad605aeb6f5a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Losartan Potassium and Hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA078245
- Marketing category
- ANDA
- Marketing start
- 2016-06-14
- Marketing end
- 0000-00-00
- Substance
- HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
- Active strength
- 25 mg/1; mg/1
- Pharmacologic classes
- Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 68788-9461 | D | Discontinued by firm | 2026-08-11 | ||
| excluded package | package | 68788-9461 | 68788-9461-1 | D | Discontinued by firm | 2026-08-11 | |
| excluded package | package | 68788-9461 | 68788-9461-3 | D | Discontinued by firm | 2026-08-11 | |
| excluded package | package | 68788-9461 | 68788-9461-6 | D | Discontinued by firm | 2026-08-11 | |
| excluded package | package | 68788-9461 | 68788-9461-9 | D | Discontinued by firm | 2026-08-11 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68788-9461-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68788-9461-3 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68788-9461-6 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68788-9461-9 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68788-9461-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68788-9461-3 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68788-9461-6 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68788-9461-9 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68788-9461-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68788-9461-3 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68788-9461-6 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68788-9461-9 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68788-9461-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68788-9461-3 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68788-9461-6 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68788-9461-9 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68788-9461-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68788-9461-3 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68788-9461-6 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68788-9461-9 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68788-9461-1 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68788-9461-3 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68788-9461-6 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68788-9461-9 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68788-9461-1 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68788-9461-3 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68788-9461-6 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68788-9461-9 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68788-9461-1 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68788-9461-3 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68788-9461-6 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68788-9461-9 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68788-9461-1 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68788-9461-3 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68788-9461-6 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68788-9461-9 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 68788-9461-1 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 68788-9461-3 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 68788-9461-6 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 68788-9461-9 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 68788-9461-1 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 68788-9461-3 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 68788-9461-6 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 68788-9461-9 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 68788-9461-1 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 68788-9461-3 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 68788-9461-6 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 68788-9461-9 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078245-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | |
| A078245-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;100MG | TABLET / ORAL | AB | 2010-05-21 | |
| A078245-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078245-001 | AB |
| A078245-002 | AB |
| A078245-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078245-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078245-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | AB | 2010-05-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078245-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078245-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078245-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | AB | 2010-05-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078245-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078245-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078245-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | AB | 2010-05-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078245-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078245-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078245-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | AB | 2010-05-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078245-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078245-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078245-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | AB | 2010-05-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078245-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078245-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078245-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | AB | 2010-05-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078245-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078245-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078245-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | AB | 2010-05-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078245-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078245-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078245-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | AB | 2010-05-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078245-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078245-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078245-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | AB | 2010-05-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078245-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078245-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078245-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | AB | 2010-05-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078245-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078245-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078245-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | AB | 2010-05-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078245-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078245-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078245-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | AB | 2010-05-21 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078245-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078245-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078245-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | AB | 2010-05-21 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078245-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078245-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078245-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078245-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078245-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078245-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078245-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078245-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078245-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078245-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078245-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078245-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078245-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078245-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078245-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078245-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078245-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078245-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078245-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078245-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078245-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078245-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078245-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078245-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078245-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078245-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078245-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078245-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078245-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078245-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078245-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078245-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078245-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078245-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078245-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078245-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078245-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078245-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078245-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078245-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078245-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A078245-001 | AB | 1 | 8072bd15b7f6… |
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 |
|---|---|---|---|---|---|---|
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Lupin Pharmaceuticals, Inc. | ee1eaaf6-050b-48af-942b-5e3451edc164 | 2026-07-16 | Boxed warning, Warnings, Adverse reactions | 078245 ANDA078245 |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Preferred Pharmaceuticals Inc. | 6eab1c0a-9328-42a6-8eae-d4e105c54716 | 2026-06-01 | Boxed warning, Warnings, Adverse reactions | 078245 ANDA078245 |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | A-S Medication Solutions | 0a34f28c-20e6-4f34-9c4a-70fb258aa300 | 2025-10-02 | Boxed warning, Warnings, Adverse reactions | 078245 ANDA078245 |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | A-S Medication Solutions | 8a3e5be8-0a4b-48a0-817f-6e3c7674109d | 2025-10-02 | Boxed warning, Warnings, Adverse reactions | 078245 ANDA078245 |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | b4f5dd93-5f44-4c8c-9e3b-89ab1fa5a7fd | 2025-01-23 | Boxed warning, Warnings, Adverse reactions | 078245 ANDA078245 |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Direct_Rx | 8de04bf2-83dd-c494-e053-2a95a90abade | 2025-01-17 | Boxed warning, Warnings, Adverse reactions | 078245 ANDA078245 |