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 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 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 · 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 N019888-001 ZESTORETIC 12.5MG;20MG TABLET / ORAL AB RLD 1990-09-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N019888-002 ZESTORETIC 25MG;20MG TABLET / ORAL AB RLD 1989-07-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N019888-003 ZESTORETIC 12.5MG;10MG TABLET / ORAL AB RLD 1993-11-18 c2088c7a36db…2026-09-14 22:38:34 2026-08 N019888-001 ZESTORETIC 12.5MG;20MG TABLET / ORAL AB RLD 1990-09-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019888-002 ZESTORETIC 25MG;20MG TABLET / ORAL AB RLD 1989-07-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019888-003 ZESTORETIC 12.5MG;10MG TABLET / ORAL AB RLD 1993-11-18 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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