Home NDC 52427-437 Zestoretic
Product NDC 52427-437
11-digit product format 524270437
Labeler code 52427
Product ID 52427-437_b8a81227-c1af-6093-4d92-647ad3fee155
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lisinopril and hydrochlorothiazide
Dosage form TABLET
Route ORAL
Labeler Almatica Pharma Inc.
Application NDA019888
Marketing category NDA
Marketing start 2015-04-15
Substance HYDROCHLOROTHIAZIDE; LISINOPRIL
Active strength 25; 20 mg/1; mg/1
Pharmacologic classes Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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.
Additional Listing Data#
Finished product Yes
Brand name base Zestoretic
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LISINOPRIL 25 mg/1 HYDROCHLOROTHIAZIDE 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0J48LPH2TH Internal UNII lookup E7199S1YWR Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197885 Internal RxNorm lookup 197886 Internal RxNorm lookup 197887 Internal RxNorm lookup 823971 Internal RxNorm lookup 823982 Internal RxNorm lookup 823986 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52427-437-90 Zestoretic 90 in 1 BOTTLE TABLET 90 16
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52427-437 ZESTORETIC (LISINOPRIL AND HYDROCHLOROTHIAZIDE) TABLET [ALMATICA PHARMA INC.] 15 Current NDC, Legacy NDC, 1 package rows 20241012_0d3a966f-f937-05a8-a90f-5aa52ebbd613.zip
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Zestoretic LISINOPRIL AND HYDROCHLOROTHIAZIDE Almatica Pharma Inc. 0d3a966f-f937-05a8-a90f-5aa52ebbd613 2025-03-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 019888 application number: NDA019888 ndc (product): 52427-437
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 52427-437-90 52427043790 90 TABLET in 1 BOTTLE (52427-437-90) 90 tablet 2015-04-15 0000-00-00 No No Current