Home NDC 65841-733-16 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Product NDC 65841-733
Requested package NDC 65841-733-16
11-digit product format 658410733
Labeler code 65841
Product ID 65841-733_de170f72-0f59-4ed3-9715-8bdff49fc5da
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Zydus Lifesciences Limited
Application ANDA078385
Marketing category ANDA
Marketing start 2010-04-10
Marketing end 0000-00-00
Substance HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Active strength 25 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 2023-12-31
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 65841-733 65841-733-16 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 65841-733 65841-733-16 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078385-001 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5MG;50MG TABLET / ORAL AB 2010-10-06 A078385-002 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25MG;100MG TABLET / ORAL AB 2010-10-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 · 86 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 A078385-001 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;50MG TABLET / ORAL AB 2010-10-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078385-002 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2010-10-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078385-001 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;50MG TABLET / ORAL AB 2010-10-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078385-002 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2010-10-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078385-001 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;50MG TABLET / ORAL AB 2010-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078385-002 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2010-10-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078385-001 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 A078385-002 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2010-10-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078385-001 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;50MG TABLET / ORAL AB 2010-10-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078385-002 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2010-10-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078385-001 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 A078385-002 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2010-10-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078385-001 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 A078385-002 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2010-10-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078385-001 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 A078385-002 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2010-10-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078385-001 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 A078385-002 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2010-10-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078385-001 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 A078385-002 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2010-10-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078385-001 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 A078385-002 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2010-10-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078385-001 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;50MG TABLET / ORAL AB 2010-10-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078385-002 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2010-10-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078385-001 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;50MG TABLET / ORAL AB 2010-10-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078385-002 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2010-10-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078385-001 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;50MG TABLET / ORAL AB 2010-10-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078385-002 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2010-10-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078385-001 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;50MG TABLET / ORAL AB 2010-10-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078385-002 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2010-10-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078385-001 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;50MG TABLET / ORAL AB 2010-10-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078385-002 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2010-10-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078385-001 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;50MG TABLET / ORAL AB 2010-10-06 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078385-002 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2010-10-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078385-001 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;50MG TABLET / ORAL AB 2010-10-06 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078385-002 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2010-10-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078385-001 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;50MG TABLET / ORAL AB 2010-10-06 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A078385-002 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2010-10-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078385-001 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5MG;50MG TABLET / ORAL AB 2010-10-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078385-002 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 25MG;100MG TABLET / ORAL AB 2010-10-06 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 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 TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 3 LOSARTAN POTASSIUM ACTIVE INGREDIENT 3ST302B24A LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 3 HYDROCHLOROTHIAZIDE ACTIVE MOIETY 0J48LPH2TH LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 3 LOSARTAN ACTIVE MOIETY JMS50MPO89 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 3 HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED INACTIVE INGREDIENT 2165RE0K14 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 3 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 3
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 65841-733-16 65841073316 90 TABLET, FILM COATED in 1 BOTTLE (65841-733-16) 2010-04-10 0000-00-00 No No Current