Home NDC 68382-142-16 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Product NDC 68382-142
Requested package NDC 68382-142-16
11-digit product format 683820142
Labeler code 68382
Product ID 68382-142_6a7df105-427c-4995-92c3-1c3b21149a33
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA078385
Marketing category ANDA
Marketing start 2010-10-04
Marketing end 0000-00-00
Substance HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Active strength 13 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 68382-142 68382-142-16 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68382-142 68382-142-16 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 [ZYDUS PHARMACEUTICALS (USA) INC.] 11 LOSARTAN POTASSIUM ACTIVE INGREDIENT 3ST302B24A LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 11 HYDROCHLOROTHIAZIDE ACTIVE MOIETY 0J48LPH2TH LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 11 LOSARTAN ACTIVE MOIETY JMS50MPO89 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 11 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 11 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 11 HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED INACTIVE INGREDIENT 2165RE0K14 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 11 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 11 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 11 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 11 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 11 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 11 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 11 TALC INACTIVE INGREDIENT 7SEV7J4R1U LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 11 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 11
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68382-142-16 68382014216 90 TABLET, FILM COATED in 1 BOTTLE (68382-142-16) 2010-10-04 0000-00-00 No No Current