Home NDC 53002-1624-0 Losartan Potassium
Product NDC 53002-1624
Requested package NDC 53002-1624-0
11-digit product format 530021624
Labeler code 53002
Product ID 53002-1624_7621f5bd-3be0-46d5-90a7-9c10c5fc2107
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Losartan Potassium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler RPK Pharmaceuticals, Inc.
Application ANDA076958
Marketing category ANDA
Marketing start 2010-04-06
Marketing end 0000-00-00
Substance LOSARTAN POTASSIUM
Active strength 25 mg/1
Pharmacologic classes Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record 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.
Historic NDC status page 1 of 1 · 17 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…2020-12-18 03:04 UTC · source 2020-12-17 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 9bebd1f3094a…5416666fcb17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076958-001 LOSARTAN POTASSIUM LOSARTAN POTASSIUM 25MG TABLET / ORAL 2010-04-06 A076958-002 LOSARTAN POTASSIUM LOSARTAN POTASSIUM 50MG TABLET / ORAL 2010-04-06 A076958-003 LOSARTAN POTASSIUM LOSARTAN POTASSIUM 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.
Product history page 1 of 4 · 126 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A076958-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL 2010-04-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076958-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL 2010-04-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076958-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL 2010-04-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076958-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL 2010-04-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076958-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL 2010-04-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076958-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL 2010-04-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076958-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL 2010-04-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076958-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL 2010-04-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076958-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL 2010-04-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076958-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL 2010-04-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076958-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL 2010-04-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076958-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL 2010-04-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076958-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL 2010-04-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076958-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL 2010-04-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076958-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL 2010-04-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076958-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL 2010-04-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076958-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL 2010-04-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076958-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL 2010-04-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076958-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL 2010-04-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076958-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL 2010-04-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076958-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL 2010-04-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076958-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL 2010-04-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076958-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL 2010-04-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076958-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL 2010-04-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076958-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL 2010-04-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076958-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL 2010-04-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076958-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL 2010-04-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076958-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL 2010-04-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076958-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL 2010-04-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076958-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL 2010-04-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076958-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL 2010-04-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076958-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL 2010-04-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076958-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL 2010-04-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076958-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL 2010-04-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076958-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL 2010-04-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076958-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL 2010-04-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076958-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL 2010-04-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076958-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL 2010-04-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076958-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL 2010-04-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076958-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL 2010-04-06 1e350fbaab3a…
Observed Orange Book normalized TE history# DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 53002-1624-0 2023-01-30 These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM Tablets, for oral use Initial U.S. Approval: 1995 53002-1624-3 2023-01-30 These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM Tablets, for oral use Initial U.S. Approval: 1995 53002-1624-9 2023-01-30 These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM Tablets, for oral use Initial U.S. Approval: 1995 53002-1624-0 2020-12-17 These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM Tablets, for oral use Initial U.S. Approval: 1995 53002-1624-3 2020-12-17 These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM Tablets, for oral use Initial U.S. Approval: 1995 53002-1624-9 2020-12-17 These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM Tablets, for oral use Initial U.S. Approval: 1995 53002-1624-0 2020-01-31 These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM Tablets, for oral use Initial U.S. Approval: 1995 53002-1624-3 2020-01-31 These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM Tablets, for oral use Initial U.S. Approval: 1995 53002-1624-9 2020-01-31 These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM Tablets, for oral use Initial U.S. Approval: 1995
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53002-1624-0 Losartan Potassium 100 in 1 BOTTLE TABLET, FILM COATED 100 3 53002-1624-3 Losartan Potassium 30 in 1 BOTTLE TABLET, FILM COATED 30 3 53002-1624-9 Losartan Potassium 90 in 1 BOTTLE TABLET, FILM COATED 90 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53002-1624 LOSARTAN POTASSIUM TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.] 3 Legacy NDC, 3 package rows 20201218_207881a6-cc87-49a5-8e8f-6266b0dba4e9.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 53002-1624-0 53002162400 100 TABLET, FILM COATED in 1 BOTTLE (53002-1624-0) 2017-09-01 0000-00-00 No No Current