Losartan Potassium
- Product NDC
- 60760-645
- Requested package NDC
- 60760-645-90
- 11-digit product format
- 607600645
- Labeler code
- 60760
- Product ID
- 60760-645_e6735480-2f09-43d8-e053-2995a90a09f2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Losartan potassium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- ST. MARY'S MEDICAL PARK PHARMACY
- Application
- ANDA091497
- Marketing category
- ANDA
- Marketing start
- 2022-07-28
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- 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 package | package | 60760-645 | 60760-645-90 | D | Discontinued by firm | 2026-08-10 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091497-001 | LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2011-06-06 | |
| A091497-002 | LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2011-06-06 | |
| A091497-003 | LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2011-06-06 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A091497-001 | AB |
| A091497-002 | AB |
| A091497-003 | 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 | A091497-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2011-06-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091497-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2011-06-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091497-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2011-06-06 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091497-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2011-06-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091497-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2011-06-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091497-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2011-06-06 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091497-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2011-06-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091497-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2011-06-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091497-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2011-06-06 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091497-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2011-06-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091497-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2011-06-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091497-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2011-06-06 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091497-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2011-06-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091497-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2011-06-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091497-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2011-06-06 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091497-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2011-06-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091497-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2011-06-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091497-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2011-06-06 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091497-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2011-06-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091497-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2011-06-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091497-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2011-06-06 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091497-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2011-06-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091497-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2011-06-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091497-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2011-06-06 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091497-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2011-06-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091497-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2011-06-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091497-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2011-06-06 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091497-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2011-06-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091497-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2011-06-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091497-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2011-06-06 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091497-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2011-06-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091497-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2011-06-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091497-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2011-06-06 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091497-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2011-06-06 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091497-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2011-06-06 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091497-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2011-06-06 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091497-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2011-06-06 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091497-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2011-06-06 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091497-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2011-06-06 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A091497-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2011-06-06 | 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 | A091497-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091497-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091497-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091497-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091497-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091497-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A091497-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091497-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091497-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091497-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091497-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091497-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091497-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091497-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091497-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091497-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091497-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091497-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091497-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091497-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091497-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091497-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091497-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091497-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091497-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091497-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091497-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A091497-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A091497-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A091497-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091497-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091497-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091497-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091497-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091497-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091497-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091497-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091497-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091497-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A091497-001 | AB | 1 | 8072bd15b7f6… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60760-645-30 | EA - Each | 60760-645 | dee58785-b4d7-40af-8673-e25494b2f1cb | 1 | 2022-09-12 |
| 60760-645-90 | EA - Each | 60760-645 | 3cf01aa7-53b1-4a92-be32-fa4062885103 | 1 | 2022-10-06 |
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 | Unit Dose Solutions, Inc. | 5529733c-1e3b-e590-e063-6294a90a765c | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | 091497 ANDA091497 |
| Losartan Potassium | LOSARTAN POTASSIUM | Coupler LLC | 53456224-db79-e7c1-e063-6394a90a90d5 | 2026-06-02 | Boxed warning, Warnings, Adverse reactions | 091497 ANDA091497 |
| Losartan Potassium | LOSARTAN POTASSIUM | Preferred Pharmaceuticals Inc. | c4b81f90-bcd0-45d0-99ce-35ca998d473a | 2026-06-01 | Boxed warning, Warnings, Adverse reactions | 091497 ANDA091497 |
| Losartan Potassium | LOSARTAN POTASSIUM | REMEDYREPACK INC. | e136356b-e4d2-4e00-a409-35825c5637c9 | 2026-02-16 | Boxed warning, Warnings, Adverse reactions | 091497 ANDA091497 |
| Losartan Potassium | LOSARTAN POTASSIUM | Solco Healthcare US, LLC | fa0cf2c2-6238-4edd-94e2-b670b98a0da4 | 2025-08-22 | Boxed warning, Warnings, Adverse reactions | 091497 ANDA091497 |
| Losartan Potassium | LOSARTAN POTASSIUM | Preferred Pharmaceuticals Inc. | 94eb89aa-296f-4e8f-a077-30a1be01ad52 | 2025-08-08 | Boxed warning, Warnings, Adverse reactions | 091497 ANDA091497 |
| Losartan Potassium | LOSARTAN POTASSIUM | Preferred Pharmaceuticals Inc. | 68ed9727-987e-4bb6-98b4-b98150bb6404 | 2025-08-01 | Boxed warning, Warnings, Adverse reactions | 091497 ANDA091497 |
| Losartan Potassium | LOSARTAN POTASSIUM | NuCare Pharmaceuticals.Inc. | 351d3c5c-05c6-921a-e063-6394a90abef9 | 2025-05-14 | Boxed warning, Warnings, Adverse reactions | 091497 ANDA091497 |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | DIRECT RX | a58c56b2-e05c-6697-e053-2a95a90ad466 | 2025-01-17 | Boxed warning, Warnings, Adverse reactions | 091497 ANDA091497 |
| Losartan Potassium | LOSARTAN POTASSIUM | NuCare Pharmaceuticals,Inc. | de5c0c87-e90b-fc14-e053-2a95a90af0c5 | 2024-12-26 | Boxed warning, Warnings, Adverse reactions | 091497 ANDA091497 |
| Losartan Potassium | LOSARTAN POTASSIUM | Bryant Ranch Prepack | 43fa4762-cc0c-4a3b-a527-6aa7fb7c5464 | 2024-08-27 | Boxed warning, Warnings, Adverse reactions | 091497 ANDA091497 |
| Losartan Potassium | LOSARTAN POTASSIUM | Bryant Ranch Prepack | de987691-f659-45ab-9c53-402ef7421f4b | 2024-08-26 | Boxed warning, Warnings, Adverse reactions | 091497 ANDA091497 |
| Losartan Potassium | LOSARTAN POTASSIUM | Proficient Rx LP | 4b298291-4251-4af8-a436-58a3443a7978 | 2024-08-01 | Boxed warning, Warnings, Adverse reactions | 091497 ANDA091497 |
| Losartan Potassium | LOSARTAN POTASSIUM | NuCare Pharmaceuticals,iNc. | 54b363c4-00bb-08db-e054-00144ff8d46c | 2024-07-17 | Boxed warning, Warnings, Adverse reactions | 091497 ANDA091497 |
| Losartan Potassium | LOSARTAN POTASSIUM | Proficient Rx LP | c0319153-3e35-4a84-aa63-935b1e0047d8 | 2022-07-01 | Boxed warning, Warnings, Adverse reactions | 091497 ANDA091497 |
| Losartan Potassium | LOSARTAN POTASSIUM | Proficient Rx LP | 1b3c03e8-da8e-4c25-a493-118e760a003b | 2022-07-01 | Boxed warning, Warnings, Adverse reactions | 091497 ANDA091497 |
| Losartan Potassium | LOSARTAN POTASSIUM | Aphena Pharma Solutions - Tennessee, LLC | 35e3472a-457f-4f95-a78d-dbff2595171d | 2019-01-21 | Boxed warning, Warnings, Adverse reactions | 091497 ANDA091497 |
| Losartan Potassium | LOSARTAN POTASSIUM | Aphena Pharma Solutions - Tennessee, LLC | 1f55aaa2-5848-47e0-bba0-6a70b2fa05dd | 2018-12-19 | Boxed warning, Warnings, Adverse reactions | 091497 ANDA091497 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 60760-645-90 | 60760064590 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-645-90) | 2022-08-11 | 0000-00-00 | No | No | Current |