Home NDC 0781-5207 Losartan potassium and hydrochlorothiazide
Product NDC 0781-5207
11-digit product format 007815207
Labeler code 0781
Product ID 0781-5207_63a4c283-dafb-4921-bb1a-364ef685c4a7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Losartan potassium and hydrochlorothiazide tablets
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sandoz Inc
Application ANDA077948
Marketing category ANDA
Marketing start 2010-10-06
Marketing end 0000-00-00
Substance LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE
Active strength 100 mg/1; mg/1
Pharmacologic classes Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
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 2 · 72 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A077948-001 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5MG;50MG TABLET / ORAL AB 2010-10-06 A077948-002 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25MG;100MG TABLET / ORAL AB 2010-10-06 A077948-003 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5MG;100MG TABLET / ORAL AB 2010-08-19
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 · 132 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 2026-10-15 13:18:30 2026-09 A077948-001 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;50MG TABLET / ORAL AB 2010-10-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077948-002 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2010-10-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077948-003 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;100MG TABLET / ORAL AB 2010-08-19 c2088c7a36db…2026-09-14 22:38:34 2026-08 A077948-001 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;50MG TABLET / ORAL AB 2010-10-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077948-002 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2010-10-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077948-003 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;100MG TABLET / ORAL AB 2010-08-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077948-001 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;50MG TABLET / ORAL AB 2010-10-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077948-002 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2010-10-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077948-003 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;100MG TABLET / ORAL AB 2010-08-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077948-001 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;50MG TABLET / ORAL AB 2010-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077948-002 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2010-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077948-003 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;100MG TABLET / ORAL AB 2010-08-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077948-001 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;50MG TABLET / ORAL AB 2010-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077948-002 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2010-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077948-003 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;100MG TABLET / ORAL AB 2010-08-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077948-001 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;50MG TABLET / ORAL AB 2010-10-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077948-002 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2010-10-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077948-003 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;100MG TABLET / ORAL AB 2010-08-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077948-001 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;50MG TABLET / ORAL AB 2010-10-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077948-002 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2010-10-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077948-003 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;100MG TABLET / ORAL AB 2010-08-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077948-001 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;50MG TABLET / ORAL AB 2010-10-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077948-002 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2010-10-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077948-003 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;100MG TABLET / ORAL AB 2010-08-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077948-001 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;50MG TABLET / ORAL AB 2010-10-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077948-002 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2010-10-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077948-003 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;100MG TABLET / ORAL AB 2010-08-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077948-001 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;50MG TABLET / ORAL AB 2010-10-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077948-002 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2010-10-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077948-003 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;100MG TABLET / ORAL AB 2010-08-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077948-001 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;50MG TABLET / ORAL AB 2010-10-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077948-002 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2010-10-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077948-003 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;100MG TABLET / ORAL AB 2010-08-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077948-001 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;50MG TABLET / ORAL AB 2010-10-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077948-002 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2010-10-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077948-003 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;100MG TABLET / ORAL AB 2010-08-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077948-001 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;50MG TABLET / ORAL AB 2010-10-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077948-002 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2010-10-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077948-003 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;100MG TABLET / ORAL AB 2010-08-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077948-001 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;50MG TABLET / ORAL AB 2010-10-06 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 4 · 132 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDROCHLOROTHIAZIDE ACTIVE INGREDIENT 0J48LPH2TH LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS) TABLET, FILM COATED [SANDOZ INC] 7 LOSARTAN POTASSIUM ACTIVE INGREDIENT 3ST302B24A LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS) TABLET, FILM COATED [SANDOZ INC] 7 HYDROCHLOROTHIAZIDE ACTIVE MOIETY 0J48LPH2TH LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS) TABLET, FILM COATED [SANDOZ INC] 7 LOSARTAN ACTIVE MOIETY JMS50MPO89 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS) TABLET, FILM COATED [SANDOZ INC] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS) TABLET, FILM COATED [SANDOZ INC] 7 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS) TABLET, FILM COATED [SANDOZ INC] 7 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS) TABLET, FILM COATED [SANDOZ INC] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS) TABLET, FILM COATED [SANDOZ INC] 7 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS) TABLET, FILM COATED [SANDOZ INC] 7 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS) TABLET, FILM COATED [SANDOZ INC] 7 TALC INACTIVE INGREDIENT 7SEV7J4R1U LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS) TABLET, FILM COATED [SANDOZ INC] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS) TABLET, FILM COATED [SANDOZ INC] 7
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0781-5207-01 00781520701 100 TABLET, FILM COATED in 1 BOTTLE (0781-5207-01) 2010-10-06 0000-00-00 No No Current 0781-5207-10 00781520710 1000 TABLET, FILM COATED in 1 BOTTLE (0781-5207-10) 2010-10-06 0000-00-00 No No Current 0781-5207-31 00781520731 30 TABLET, FILM COATED in 1 BOTTLE (0781-5207-31) 2010-10-06 0000-00-00 No No Current 0781-5207-74 00781520774 4000 TABLET, FILM COATED in 1 BOTTLE (0781-5207-74) 2010-10-06 0000-00-00 No No Current 0781-5207-92 00781520792 90 TABLET, FILM COATED in 1 BOTTLE (0781-5207-92) 2010-10-06 0000-00-00 No No Current