Home NDC 0781-5700 Losartan potassium
Product NDC 0781-5700
11-digit product format 007815700
Labeler code 0781
Product ID 0781-5700_e0b9eaef-95a8-42d5-8970-471d7f52e11f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name losartan potassium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sandoz Inc
Application ANDA077424
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 2020-12-31
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 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A077424-001 LOSARTAN POTASSIUM LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2010-10-06 A077424-002 LOSARTAN POTASSIUM LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2010-10-06 A077424-003 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 · 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 A077424-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2010-10-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077424-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2010-10-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077424-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2010-10-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077424-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2010-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077424-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2010-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077424-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2010-10-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077424-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2010-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077424-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2010-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077424-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2010-10-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077424-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2010-10-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077424-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2010-10-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077424-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2010-10-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077424-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2010-10-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077424-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2010-10-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077424-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2010-10-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077424-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2010-10-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077424-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2010-10-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077424-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2010-10-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077424-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2010-10-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077424-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2010-10-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077424-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2010-10-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077424-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2010-10-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077424-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2010-10-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077424-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2010-10-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077424-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2010-10-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077424-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2010-10-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077424-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2010-10-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077424-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2010-10-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077424-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2010-10-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077424-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2010-10-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077424-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2010-10-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077424-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2010-10-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077424-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2010-10-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077424-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2010-10-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077424-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2010-10-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077424-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2010-10-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077424-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2010-10-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077424-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2010-10-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077424-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2010-10-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077424-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2010-10-06 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
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 [SANDOZ INC] 8 LOSARTAN ACTIVE MOIETY JMS50MPO89 LOSARTAN POTASSIUM TABLET, FILM COATED [SANDOZ INC] 8 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LOSARTAN POTASSIUM TABLET, FILM COATED [SANDOZ INC] 8 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 LOSARTAN POTASSIUM TABLET, FILM COATED [SANDOZ INC] 8 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 LOSARTAN POTASSIUM TABLET, FILM COATED [SANDOZ INC] 8 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P LOSARTAN POTASSIUM TABLET, FILM COATED [SANDOZ INC] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LOSARTAN POTASSIUM TABLET, FILM COATED [SANDOZ INC] 8 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LOSARTAN POTASSIUM TABLET, FILM COATED [SANDOZ INC] 8 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP LOSARTAN POTASSIUM TABLET, FILM COATED [SANDOZ INC] 8 TALC INACTIVE INGREDIENT 7SEV7J4R1U LOSARTAN POTASSIUM TABLET, FILM COATED [SANDOZ INC] 8 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LOSARTAN POTASSIUM TABLET, FILM COATED [SANDOZ INC] 8 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM LOSARTAN POTASSIUM TABLET, FILM COATED [SANDOZ INC] 8 LOSARTAN POTASSIUM ACTIVE INGREDIENT 3ST302B24A LOSARTAN POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 7 LOSARTAN ACTIVE MOIETY JMS50MPO89 LOSARTAN POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LOSARTAN POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 7 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 LOSARTAN POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 7 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 LOSARTAN POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 7 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P LOSARTAN POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LOSARTAN POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 7 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LOSARTAN POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 7 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP LOSARTAN POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 7 TALC INACTIVE INGREDIENT 7SEV7J4R1U LOSARTAN POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LOSARTAN POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 7 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM LOSARTAN POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 7
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0781-5700-01 00781570001 100 TABLET, FILM COATED in 1 BOTTLE (0781-5700-01) 2010-10-06 0000-00-00 No No Current 0781-5700-10 00781570010 1000 TABLET, FILM COATED in 1 BOTTLE (0781-5700-10) 2010-10-06 0000-00-00 No No Current 0781-5700-92 00781570092 90 TABLET, FILM COATED in 1 BOTTLE (0781-5700-92) 2010-10-06 0000-00-00 No No Current