Home NDC 33342-044 Losartan potassium
Product NDC 33342-044
11-digit product format 333420044
Labeler code 33342
Product ID 33342-044_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 2012-05-10
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 2026-12-31
Current FDA listing Yes 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 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# 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 · 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 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…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202230-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2012-05-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202230-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2012-05-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202230-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2012-05-30 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Losartan potassium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LOSARTAN POTASSIUM 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3ST302B24A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 979480 Internal RxNorm lookup 979485 Internal RxNorm lookup 979492 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 33342-044-07 Losartan potassium 30 in 1 BOTTLE TABLET, FILM COATED 30 8 33342-044-10 Losartan potassium 90 in 1 BOTTLE TABLET, FILM COATED 90 8 33342-044-12 Losartan potassium 10 in 1 CARTON TABLET, FILM COATED 10 8 33342-044-12 Losartan potassium 10 in 1 BLISTER PACK TABLET, FILM COATED 10 8 33342-044-44 Losartan potassium 1000 in 1 BOTTLE TABLET, FILM COATED 1000 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LOSARTAN POTASSIUM ACTIVE INGREDIENT 3ST302B24A LOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 3 LOSARTAN ACTIVE MOIETY JMS50MPO89 LOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 3 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 LOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO LOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X LOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 3 METHYL CHLORIDE INACTIVE INGREDIENT A6R43525YO LOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 3 POVIDONE INACTIVE INGREDIENT FZ989GH94E LOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-044 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.
Matched openFDA labels page 1 of 1 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Losartan potassium LOSARTAN POTASSIUM Preferred Pharmaceuticals Inc. 628d0317-b844-42a0-9c27-48e1e23a38f5 2026-06-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202230 application number: ANDA202230 Losartan potassium LOSARTAN POTASSIUM REMEDYREPACK INC. a397502e-abe7-49cf-97c7-d53a616947eb 2025-10-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202230 application number: ANDA202230 Losartan potassium LOSARTAN POTASSIUM Macleods Pharmaceuticals Limited 85d69d02-c5ef-467e-94aa-903100218795 2025-07-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202230 application number: ANDA202230 ndc (product): 33342-044 Losartan potassium LOSARTAN POTASSIUM Coupler LLC 2d1b1648-8b24-cf4f-e063-6294a90afdd8 2025-02-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202230 application number: ANDA202230
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 33342-044-07 33342004407 30 TABLET, FILM COATED in 1 BOTTLE (33342-044-07) 2012-05-10 0000-00-00 No No Current 33342-044-10 33342004410 90 TABLET, FILM COATED in 1 BOTTLE (33342-044-10) 2012-05-10 0000-00-00 No No Current 33342-044-12 33342004412 10 BLISTER PACK in 1 CARTON (33342-044-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK 10 blister pack 2012-05-10 0000-00-00 No No Current 33342-044-44 33342004444 1000 TABLET, FILM COATED in 1 BOTTLE (33342-044-44) 2016-01-18 0000-00-00 No No Current