Home Applications 019888 Application 019888
Type NDA
Sponsor ALVOGEN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ZESTORETIC HYDROCHLOROTHIAZIDE; LISINOPRIL TABLET;ORAL 12.5MG;20MG Yes Yes 002 ZESTORETIC HYDROCHLOROTHIAZIDE; LISINOPRIL TABLET;ORAL 25MG;20MG Yes Yes 003 ZESTORETIC HYDROCHLOROTHIAZIDE; LISINOPRIL TABLET;ORAL 12.5MG;10MG Yes No
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 N019888-001 ZESTORETIC HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;20MG TABLET / ORAL AB RLD 1990-09-20 N019888-002 ZESTORETIC HYDROCHLOROTHIAZIDE; LISINOPRIL 25MG;20MG TABLET / ORAL AB RLD 1989-07-20 N019888-003 ZESTORETIC HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;10MG TABLET / ORAL AB RLD 1993-11-18
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 N019888-001 ZESTORETIC 12.5MG;20MG TABLET / ORAL AB RLD 1990-09-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019888-002 ZESTORETIC 25MG;20MG TABLET / ORAL AB RLD 1989-07-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019888-003 ZESTORETIC 12.5MG;10MG TABLET / ORAL AB RLD 1993-11-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019888-001 ZESTORETIC 12.5MG;20MG TABLET / ORAL AB RLD 1990-09-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019888-002 ZESTORETIC 25MG;20MG TABLET / ORAL AB RLD 1989-07-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019888-003 ZESTORETIC 12.5MG;10MG TABLET / ORAL AB RLD 1993-11-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019888-001 ZESTORETIC 12.5MG;20MG TABLET / ORAL AB RLD 1990-09-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019888-002 ZESTORETIC 25MG;20MG TABLET / ORAL AB RLD 1989-07-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019888-003 ZESTORETIC 12.5MG;10MG TABLET / ORAL AB RLD 1993-11-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019888-001 ZESTORETIC 12.5MG;20MG TABLET / ORAL AB RLD 1990-09-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019888-002 ZESTORETIC 25MG;20MG TABLET / ORAL AB RLD 1989-07-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019888-003 ZESTORETIC 12.5MG;10MG TABLET / ORAL AB RLD 1993-11-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019888-001 ZESTORETIC 12.5MG;20MG TABLET / ORAL AB RLD 1990-09-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019888-002 ZESTORETIC 25MG;20MG TABLET / ORAL AB RLD 1989-07-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019888-003 ZESTORETIC 12.5MG;10MG TABLET / ORAL AB RLD 1993-11-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019888-001 ZESTORETIC 12.5MG;20MG TABLET / ORAL AB RLD 1990-09-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019888-002 ZESTORETIC 25MG;20MG TABLET / ORAL AB RLD 1989-07-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019888-003 ZESTORETIC 12.5MG;10MG TABLET / ORAL AB RLD 1993-11-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019888-001 ZESTORETIC 12.5MG;20MG TABLET / ORAL AB RLD 1990-09-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019888-002 ZESTORETIC 25MG;20MG TABLET / ORAL AB RLD 1989-07-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019888-003 ZESTORETIC 12.5MG;10MG TABLET / ORAL AB RLD 1993-11-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019888-001 ZESTORETIC 12.5MG;20MG TABLET / ORAL AB RLD 1990-09-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019888-002 ZESTORETIC 25MG;20MG TABLET / ORAL AB RLD 1989-07-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019888-003 ZESTORETIC 12.5MG;10MG TABLET / ORAL AB RLD 1993-11-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019888-001 ZESTORETIC 12.5MG;20MG TABLET / ORAL AB RLD 1990-09-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019888-002 ZESTORETIC 25MG;20MG TABLET / ORAL AB RLD 1989-07-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019888-003 ZESTORETIC 12.5MG;10MG TABLET / ORAL AB RLD 1993-11-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019888-001 ZESTORETIC 12.5MG;20MG TABLET / ORAL AB RLD 1990-09-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019888-002 ZESTORETIC 25MG;20MG TABLET / ORAL AB RLD 1989-07-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019888-003 ZESTORETIC 12.5MG;10MG TABLET / ORAL AB RLD 1993-11-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019888-001 ZESTORETIC 12.5MG;20MG TABLET / ORAL AB RLD 1990-09-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N019888-002 ZESTORETIC 25MG;20MG TABLET / ORAL AB RLD 1989-07-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N019888-003 ZESTORETIC 12.5MG;10MG TABLET / ORAL AB RLD 1993-11-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019888-001 ZESTORETIC 12.5MG;20MG TABLET / ORAL AB RLD 1990-09-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019888-002 ZESTORETIC 25MG;20MG TABLET / ORAL AB RLD 1989-07-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019888-003 ZESTORETIC 12.5MG;10MG TABLET / ORAL AB RLD 1993-11-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019888-001 ZESTORETIC 12.5MG;20MG TABLET / ORAL AB RLD 1990-09-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019888-002 ZESTORETIC 25MG;20MG TABLET / ORAL AB RLD 1989-07-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019888-003 ZESTORETIC 12.5MG;10MG TABLET / ORAL AB RLD 1993-11-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019888-001 ZESTORETIC 12.5MG;20MG TABLET / ORAL AB RLD 1990-09-20 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
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 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 15 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 52427-435 Zestoretic lisinopril and hydrochlorothiazide Almatica Pharma Inc. NDA Current 52427-435 Zestoretic lisinopril and hydrochlorothiazide Almatica Pharma Inc. NDA Current 52427-435 Zestoretic lisinopril and hydrochlorothiazide Almatica Pharma Inc. NDA Current 52427-435 Zestoretic lisinopril and hydrochlorothiazide Almatica Pharma Inc. NDA Current 52427-435 Zestoretic lisinopril and hydrochlorothiazide Almatica Pharma Inc. NDA Current 52427-436 Zestoretic lisinopril and hydrochlorothiazide Almatica Pharma Inc. NDA Current 52427-436 Zestoretic lisinopril and hydrochlorothiazide Almatica Pharma Inc. NDA Current 52427-436 Zestoretic lisinopril and hydrochlorothiazide Almatica Pharma Inc. NDA Current 52427-436 Zestoretic lisinopril and hydrochlorothiazide Almatica Pharma Inc. NDA Current 52427-436 Zestoretic lisinopril and hydrochlorothiazide Almatica Pharma Inc. NDA Current 52427-437 Zestoretic lisinopril and hydrochlorothiazide Almatica Pharma Inc. NDA Current 52427-437 Zestoretic lisinopril and hydrochlorothiazide Almatica Pharma Inc. NDA Current 52427-437 Zestoretic lisinopril and hydrochlorothiazide Almatica Pharma Inc. NDA Current 52427-437 Zestoretic lisinopril and hydrochlorothiazide Almatica Pharma Inc. NDA Current 52427-437 Zestoretic lisinopril and hydrochlorothiazide Almatica Pharma Inc. NDA Current