Losartan Potassium and Hydrochlorothiazide
- Product NDC
- 63187-405
- 11-digit product format
- 631870405
- Labeler code
- 63187
- Product ID
- 63187-405_0d66603d-b111-4b2e-a841-c47935b8c41a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Losartan Potassium and Hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA090528
- Marketing category
- ANDA
- Marketing start
- 2010-04-06
- Marketing end
- 0000-00-00
- Substance
- HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
- Active strength
- 13 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
- No
- Listing certified through
- 2022-12-31
- 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 | 63187-405 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 63187-405 | 63187-405-30 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 63187-405 | 63187-405-60 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 63187-405 | 63187-405-90 | D | Discontinued by firm | 2026-08-03 |
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 | 63187-405-90 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63187-405-60 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63187-405-30 | 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 | 63187-405-90 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 63187-405-60 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 63187-405-30 | f5e01cc5f278… | a2eaf40c39c3… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090528-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;50MG | TABLET / ORAL | 2010-10-06 | ||
| A090528-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 25MG;100MG | TABLET / ORAL | 2010-10-06 | ||
| A090528-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;100MG | TABLET / ORAL | 2010-04-06 |
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 | A090528-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | 2010-10-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090528-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2010-10-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090528-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | 2010-04-06 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090528-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | 2010-10-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090528-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2010-10-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090528-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | 2010-04-06 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090528-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | 2010-10-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090528-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2010-10-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090528-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | 2010-04-06 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090528-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | 2010-10-06 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090528-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2010-10-06 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090528-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | 2010-04-06 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090528-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | 2010-10-06 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090528-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2010-10-06 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090528-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | 2010-04-06 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090528-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | 2010-10-06 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090528-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2010-10-06 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090528-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | 2010-04-06 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090528-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | 2010-10-06 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090528-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2010-10-06 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090528-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | 2010-04-06 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090528-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | 2010-10-06 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090528-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2010-10-06 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090528-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | 2010-04-06 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090528-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | 2010-10-06 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090528-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2010-10-06 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090528-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | 2010-04-06 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090528-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | 2010-10-06 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090528-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2010-10-06 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090528-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | 2010-04-06 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090528-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | 2010-10-06 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090528-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2010-10-06 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090528-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | 2010-04-06 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090528-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | 2010-10-06 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090528-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2010-10-06 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090528-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | 2010-04-06 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090528-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | 2010-10-06 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090528-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2010-10-06 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090528-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | 2010-04-06 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A090528-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | 2010-10-06 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A090528-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A090528-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A090528-003 | AB | 1 | 74a2ff9319b5… |
| 2021-12-28 21:50 UTC | 2021-12 | A090528-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A090528-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A090528-003 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090528-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090528-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090528-003 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A090528-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A090528-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A090528-003 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A090528-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A090528-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A090528-003 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A090528-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A090528-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A090528-003 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A090528-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A090528-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A090528-003 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A090528-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A090528-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A090528-003 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A090528-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A090528-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A090528-003 | AB | 1 | ea99ee380514… |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| HYDROCHLOROTHIAZIDE | ACTIVE INGREDIENT | 0J48LPH2TH | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP] | 2 | |
| LOSARTAN POTASSIUM | ACTIVE INGREDIENT | 3ST302B24A | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP] | 2 | |
| HYDROCHLOROTHIAZIDE | ACTIVE MOIETY | 0J48LPH2TH | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP] | 2 | |
| LOSARTAN | ACTIVE MOIETY | JMS50MPO89 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP] | 2 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP] | 2 |
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63187-405-30 | 63187040530 | 30 TABLET in 1 BOTTLE (63187-405-30) | 30 tablet | 2019-01-01 | 0000-00-00 | No | No | Current |
| 63187-405-60 | 63187040560 | 60 TABLET in 1 BOTTLE (63187-405-60) | 60 tablet | 2019-01-01 | 0000-00-00 | No | No | Current |
| 63187-405-90 | 63187040590 | 90 TABLET in 1 BOTTLE (63187-405-90) | 90 tablet | 2019-01-01 | 0000-00-00 | No | No | Current |