Losartan potassium
- Product NDC
- 33342-046
- Requested package NDC
- 33342-046-12
- 11-digit product format
- 333420046
- Labeler code
- 33342
- Product ID
- 33342-046_81824d1f-61f4-457c-8723-cd43d5429029
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Losartan potassium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA202230
- Marketing category
- ANDA
- Marketing start
- 2012-06-01
- Substance
- LOSARTAN POTASSIUM
- Active strength
- 100 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 |
|---|---|---|---|---|---|---|---|
| A202230-001 | LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2012-05-30 | |
| A202230-002 | LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2012-05-30 | |
| A202230-003 | LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2012-05-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202230-001 | AB |
| A202230-002 | AB |
| A202230-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A202230-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2012-05-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A202230-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2012-05-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A202230-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2012-05-30 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A202230-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2012-05-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202230-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2012-05-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202230-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2012-05-30 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202230-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2012-05-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202230-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2012-05-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202230-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2012-05-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202230-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2012-05-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202230-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2012-05-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202230-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2012-05-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202230-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2012-05-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202230-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2012-05-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202230-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2012-05-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202230-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2012-05-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202230-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2012-05-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202230-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2012-05-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202230-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2012-05-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202230-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2012-05-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202230-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2012-05-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202230-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2012-05-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202230-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2012-05-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202230-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2012-05-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202230-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2012-05-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202230-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2012-05-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202230-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2012-05-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202230-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2012-05-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202230-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2012-05-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202230-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2012-05-30 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202230-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2012-05-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202230-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2012-05-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202230-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2012-05-30 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202230-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2012-05-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202230-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2012-05-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202230-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2012-05-30 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202230-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2012-05-30 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202230-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2012-05-30 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202230-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2012-05-30 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202230-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2012-05-30 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A202230-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A202230-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A202230-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A202230-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202230-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202230-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A202230-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202230-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202230-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202230-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202230-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202230-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202230-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202230-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202230-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202230-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202230-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202230-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202230-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202230-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202230-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202230-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202230-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202230-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202230-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202230-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202230-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202230-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202230-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202230-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202230-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202230-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202230-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A202230-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202230-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202230-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202230-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202230-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202230-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202230-001 | AB | 1 | 301d65b070ca… |
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
- Losartan potassium
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LOSARTAN POTASSIUM | 100 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3ST302B24A | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 85d69d02-c5ef-467e-94aa-903100218795 | 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 |
|---|---|---|---|---|---|---|
| 33342-046-07 | Losartan potassium | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 8 | |
| 33342-046-10 | Losartan potassium | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 8 | |
| 33342-046-12 | Losartan potassium | 10 in 1 CARTON | TABLET, FILM COATED | 10 | 8 | |
| 33342-046-12 | Losartan potassium | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | 8 | |
| 33342-046-44 | Losartan potassium | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 33342-046-07 | EA - Each | 33342-046 | 20bbf6cf-e556-4bb7-94d7-59af7ac3238d | 1 | 2015-08-04 |
| 33342-046-10 | EA - Each | 33342-046 | 943749f1-f56a-438e-8870-bd2a3f1c8a99 | 1 | 2015-08-04 |
| 33342-046-44 | EA - Each | 33342-046 | fc72bea7-4a69-4d3c-ab0f-8619a2853553 | 1 | 2015-08-04 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 33342-046 | LOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 7 | Current NDC, Legacy NDC, 5 package rows | 20230202_85d69d02-c5ef-467e-94aa-903100218795.zip |
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 | REMEDYREPACK INC. | a397502e-abe7-49cf-97c7-d53a616947eb | 2026-09-03 | Boxed warning, Warnings, Adverse reactions | 202230 ANDA202230 |
| Losartan potassium | LOSARTAN POTASSIUM | Preferred Pharmaceuticals Inc. | 628d0317-b844-42a0-9c27-48e1e23a38f5 | 2026-06-09 | Boxed warning, Warnings, Adverse reactions | 202230 ANDA202230 |
| Losartan potassium | LOSARTAN POTASSIUM | Macleods Pharmaceuticals Limited | 85d69d02-c5ef-467e-94aa-903100218795 | 2025-07-28 | Boxed warning, Warnings, Adverse reactions | 202230 ANDA202230 33342-046-12 33342-046 33342004612 |
| Losartan potassium | LOSARTAN POTASSIUM | Coupler LLC | 2d1b1648-8b24-cf4f-e063-6294a90afdd8 | 2025-02-01 | Boxed warning, Warnings, Adverse reactions | 202230 ANDA202230 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 33342-046-12 | 33342004612 | 10 BLISTER PACK in 1 CARTON (33342-046-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2012-06-01 | 0000-00-00 | No | No | Current |