Losortan Potassium
- Product NDC
- 63187-071
- Requested package NDC
- 63187-071-90
- 11-digit product format
- 631870071
- Labeler code
- 63187
- Product ID
- 63187-071_317c5935-98fa-4bf4-9a07-c19b6daab2ea
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Losartan Potassium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA078243
- Marketing category
- ANDA
- Marketing start
- 2010-10-04
- Substance
- LOSARTAN POTASSIUM
- Active strength
- 50 mg/1
- Pharmacologic classes
- Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078243-001 | LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2010-10-06 | |
| A078243-002 | LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2010-10-06 | |
| A078243-003 | LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2010-10-06 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078243-001 | AB |
| A078243-002 | AB |
| A078243-003 | 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 | A078243-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2010-10-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078243-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2010-10-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078243-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2010-10-06 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078243-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2010-10-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078243-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2010-10-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078243-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2010-10-06 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078243-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2010-10-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078243-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2010-10-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078243-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2010-10-06 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078243-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2010-10-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078243-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2010-10-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078243-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2010-10-06 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078243-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2010-10-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078243-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2010-10-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078243-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2010-10-06 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078243-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2010-10-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078243-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2010-10-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078243-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2010-10-06 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078243-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2010-10-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078243-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2010-10-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078243-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2010-10-06 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078243-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2010-10-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078243-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2010-10-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078243-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2010-10-06 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078243-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2010-10-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078243-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2010-10-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078243-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2010-10-06 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078243-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2010-10-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078243-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2010-10-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078243-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2010-10-06 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078243-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2010-10-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078243-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2010-10-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078243-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2010-10-06 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078243-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2010-10-06 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078243-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2010-10-06 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078243-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2010-10-06 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078243-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2010-10-06 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078243-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2010-10-06 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078243-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2010-10-06 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078243-001 | LOSARTAN POTASSIUM | 25MG | 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 | A078243-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078243-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078243-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078243-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078243-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078243-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078243-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078243-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078243-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078243-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078243-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078243-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078243-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078243-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078243-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078243-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078243-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078243-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078243-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078243-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078243-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078243-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078243-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078243-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078243-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078243-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078243-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078243-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078243-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078243-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078243-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078243-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078243-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078243-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078243-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078243-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078243-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078243-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078243-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A078243-001 | AB | 1 | 8072bd15b7f6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Losortan Potassium
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LOSARTAN POTASSIUM | 50 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3ST302B24A | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 364fe10e-11ca-4ee6-9f67-c85dec09aca5 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0d341e63-aee5-498b-bf9a-b53a43963acf | Product name | 1 | 20260105 |
| de29c5c0-90ba-29da-d7ab-0500274708be | Product name | 6 | 20241009 |
| 15b375b1-89c7-9594-80df-5a8c8864aee0 | Product name | 3 | 20180108 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63187-071-30 | Losortan Potassium | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 6 | |
| 63187-071-60 | Losortan Potassium | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 6 | |
| 63187-071-90 | Losortan Potassium | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 6 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| Losartan Potassium | LOSARTAN POTASSIUM | Zydus Pharmaceuticals USA Inc. | 3233c707-70b6-4c29-8210-913eeb2a38ed | 2026-07-20 | Boxed warning, Warnings, Adverse reactions | 078243 ANDA078243 |
| Losartan Potassium | LOSARTAN POTASSIUM | American Health Packaging | e7f6b25b-ec4c-4c3a-a541-617d2d9ab393 | 2026-06-24 | Boxed warning, Warnings, Adverse reactions | 078243 ANDA078243 |
| Losartan Potassium | LOSARTAN POTASSIUM | Cardinal Health 107, LLC | b83d896a-c7e9-4508-814c-425b88a87b16 | 2026-06-05 | Boxed warning, Warnings, Adverse reactions | 078243 ANDA078243 |
| Losortan Potassium | LOSARTAN POTASSIUM | Preferred Pharmaceuticals Inc. | 25651749-8950-43ff-bcbd-3bb85f57a360 | 2026-05-29 | Boxed warning, Warnings, Adverse reactions | 078243 ANDA078243 |
| Losortan Potassium | LOSARTAN POTASSIUM | Bryant Ranch Prepack | 1b285c10-f468-4d87-b36d-79047f686c58 | 2026-05-14 | Boxed warning, Warnings, Adverse reactions | 078243 ANDA078243 |
| Losartan Potassium | LOSARTAN POTASSIUM | Zydus Lifesciences Limited | 9ccd6823-e813-472c-99cd-c6ef25e74bed | 2026-01-12 | 078243 ANDA078243 | |
| Losartan Potassium | LOSARTAN POTASSIUM | Quallent Pharmaceuticals Health LLC | 1a9e1ffd-edf1-4e35-a7f5-ca351c507d7f | 2026-01-12 | Boxed warning, Warnings, Adverse reactions | 078243 ANDA078243 |
| Losortan Potassium | LOSARTAN POTASSIUM | AvPAK | a6cd0b5f-2bd6-bed9-e053-2995a90a3191 | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | 078243 ANDA078243 |
| Losartan Potassium | LOSARTAN POTASSIUM | Major Pharmaceuticals | c15387df-87a4-4784-acb5-7dd550498f8f | 2025-12-10 | Boxed warning, Warnings, Adverse reactions | 078243 ANDA078243 |
| Losartan Potassium | LOSARTAN POTASSIUM | Cardinal Health 107, LLC | 021cd76a-b093-4704-8410-5e7d01e20a54 | 2025-10-22 | Boxed warning, Warnings, Adverse reactions | 078243 ANDA078243 |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | DIRECT RX | a58c56b2-e05c-6697-e053-2a95a90ad466 | 2025-01-17 | Boxed warning, Warnings, Adverse reactions | 078243 ANDA078243 |
| Losartan Potassium | LOSARTAN POTASSIUM | NCS HealthCare of KY, LLC dba Vangard Labs | c565e7ba-97aa-4a65-80e6-543e9af6e1c4 | 2025-01-03 | Boxed warning, Warnings, Adverse reactions | 078243 ANDA078243 |
| Losortan Potassium | LOSARTAN POTASSIUM | Proficient Rx LP | 364fe10e-11ca-4ee6-9f67-c85dec09aca5 | 2019-11-01 | Boxed warning, Warnings, Adverse reactions | 078243 ANDA078243 63187-071-90 63187-071 63187007190 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 979480 | losartan potassium 100 MG Oral Tablet | PSN | 364fe10e-11ca-4ee6-9f67-c85dec09aca5 | 6 |
| 979492 | losartan potassium 50 MG Oral Tablet | PSN | 364fe10e-11ca-4ee6-9f67-c85dec09aca5 | 6 |
| 979480 | losartan potassium 100 MG Oral Tablet | SCD | 364fe10e-11ca-4ee6-9f67-c85dec09aca5 | 6 |
| 979492 | losartan potassium 50 MG Oral Tablet | SCD | 364fe10e-11ca-4ee6-9f67-c85dec09aca5 | 6 |
| 979480 | Losartan K+ 100 MG Oral Tablet | SY | 364fe10e-11ca-4ee6-9f67-c85dec09aca5 | 6 |
| 979492 | Losartan K+ 50 MG Oral Tablet | SY | 364fe10e-11ca-4ee6-9f67-c85dec09aca5 | 6 |
| 979480 | Losartan Pot 100 MG Oral Tablet | SY | 364fe10e-11ca-4ee6-9f67-c85dec09aca5 | 6 |
| 979492 | Losartan Pot 50 MG Oral Tablet | SY | 364fe10e-11ca-4ee6-9f67-c85dec09aca5 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 63187-071-90 | 63187007190 | 90 TABLET, FILM COATED in 1 BOTTLE (63187-071-90) | 2014-04-30 | 0000-00-00 | No | No | Current |