Home NDC 53002-5624 Losartan Potassium
Product NDC 53002-5624
11-digit product format 530025624
Labeler code 53002
Product ID 53002-5624_eaf41ac8-b7b1-44d7-a887-f82336270d25
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Losartan Potassium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler RPK Pharmaceuticals, Inc.
Application ANDA090083
Marketing category ANDA
Marketing start 2010-10-06
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 2022-12-31
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 53002-5624-0 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 53002-5624-9 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 53002-5624-3 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 53002-5624-0 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 53002-5624-9 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 53002-5624-3 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 53002-5624-0 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 53002-5624-9 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 53002-5624-3 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 53002-5624-0 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 53002-5624-9 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 53002-5624-3 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 53002-5624-0 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 53002-5624-9 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 53002-5624-3 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 53002-5624-0 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 53002-5624-9 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 53002-5624-3 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 53002-5624-9 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 53002-5624-0 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 53002-5624-3 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53002-5624-9 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53002-5624-0 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53002-5624-3 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53002-5624-9 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53002-5624-0 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53002-5624-3 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A090083-001 LOSARTAN POTASSIUM LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2010-10-06 A090083-002 LOSARTAN POTASSIUM LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2010-10-06 A090083-003 LOSARTAN POTASSIUM LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2010-10-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 · 129 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 2026-09-14 22:38:34 2026-08 A090083-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2010-10-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090083-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2010-10-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090083-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2010-10-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090083-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2010-10-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090083-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2010-10-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090083-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2010-10-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090083-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2010-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090083-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2010-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090083-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2010-10-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090083-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2010-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090083-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2010-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090083-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2010-10-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090083-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2010-10-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090083-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2010-10-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090083-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2010-10-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090083-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2010-10-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090083-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2010-10-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090083-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2010-10-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090083-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2010-10-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090083-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2010-10-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090083-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2010-10-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090083-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2010-10-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090083-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2010-10-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090083-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2010-10-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090083-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2010-10-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090083-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2010-10-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090083-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2010-10-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090083-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2010-10-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090083-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2010-10-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090083-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2010-10-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090083-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2010-10-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090083-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2010-10-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090083-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2010-10-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090083-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2010-10-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090083-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2010-10-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090083-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2010-10-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090083-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2010-10-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090083-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2010-10-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090083-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2010-10-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090083-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2010-10-06 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 53002-5624-0 2025-01-30 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 53002-5624-3 2025-01-30 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 53002-5624-9 2025-01-30 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 53002-5624-0 2023-06-08 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 53002-5624-3 2023-06-08 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 53002-5624-9 2023-06-08 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 53002-5624-0 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 53002-5624-3 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 53002-5624-9 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
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53002-5624-0 Losartan Potassium 100 in 1 BOTTLE TABLET, FILM COATED 100 8 53002-5624-3 Losartan Potassium 30 in 1 BOTTLE TABLET, FILM COATED 30 8 53002-5624-9 Losartan Potassium 90 in 1 BOTTLE TABLET, FILM COATED 90 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53002-5624 LOSARTAN POTASSIUM TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.] 8 Legacy NDC, 3 package rows 20230609_8dfe73ee-7815-404b-801a-57482688271c.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.
Matched openFDA labels page 2 of 2 · 23 matching rows.
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 53002-5624-0 53002562400 100 TABLET, FILM COATED in 1 BOTTLE (53002-5624-0) 2019-01-01 0000-00-00 No No Current 53002-5624-3 53002562403 30 TABLET, FILM COATED in 1 BOTTLE (53002-5624-3) 2019-01-01 0000-00-00 No No Current 53002-5624-9 53002562409 90 TABLET, FILM COATED in 1 BOTTLE (53002-5624-9) 2019-01-01 0000-00-00 No No Current