Home Applications 019777 Application 019777
Type NDA
Sponsor ALVOGEN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ZESTRIL LISINOPRIL TABLET;ORAL 5MG Yes No 002 ZESTRIL LISINOPRIL TABLET;ORAL 10MG Yes No 003 ZESTRIL LISINOPRIL TABLET;ORAL 20MG Yes No 004 ZESTRIL LISINOPRIL TABLET;ORAL 40MG Yes Yes 005 ZESTRIL LISINOPRIL TABLET;ORAL 2.5MG Yes No 006 ZESTRIL LISINOPRIL TABLET;ORAL 30MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019777-001 ZESTRIL LISINOPRIL 5MG TABLET / ORAL AB RLD 1988-05-19 N019777-002 ZESTRIL LISINOPRIL 10MG TABLET / ORAL AB RLD 1988-05-19 N019777-003 ZESTRIL LISINOPRIL 20MG TABLET / ORAL AB RLD 1988-05-19 N019777-004 ZESTRIL LISINOPRIL 40MG TABLET / ORAL AB RLD, RS 1988-05-19 N019777-005 ZESTRIL LISINOPRIL 2.5MG TABLET / ORAL AB RLD 1993-04-29 N019777-006 ZESTRIL LISINOPRIL 30MG TABLET / ORAL AB RLD 1999-01-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 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 7 · 252 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 N019777-001 ZESTRIL 5MG TABLET / ORAL AB RLD 1988-05-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019777-002 ZESTRIL 10MG TABLET / ORAL AB RLD 1988-05-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019777-003 ZESTRIL 20MG TABLET / ORAL AB RLD 1988-05-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019777-004 ZESTRIL 40MG TABLET / ORAL AB RLD, RS 1988-05-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019777-005 ZESTRIL 2.5MG TABLET / ORAL AB RLD 1993-04-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019777-006 ZESTRIL 30MG TABLET / ORAL AB RLD 1999-01-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019777-001 ZESTRIL 5MG TABLET / ORAL AB RLD 1988-05-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019777-002 ZESTRIL 10MG TABLET / ORAL AB RLD 1988-05-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019777-003 ZESTRIL 20MG TABLET / ORAL AB RLD 1988-05-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019777-004 ZESTRIL 40MG TABLET / ORAL AB RLD, RS 1988-05-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019777-005 ZESTRIL 2.5MG TABLET / ORAL AB RLD 1993-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019777-006 ZESTRIL 30MG TABLET / ORAL AB RLD 1999-01-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019777-001 ZESTRIL 5MG TABLET / ORAL AB RLD 1988-05-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019777-002 ZESTRIL 10MG TABLET / ORAL AB RLD 1988-05-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019777-003 ZESTRIL 20MG TABLET / ORAL AB RLD 1988-05-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019777-004 ZESTRIL 40MG TABLET / ORAL AB RLD, RS 1988-05-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019777-005 ZESTRIL 2.5MG TABLET / ORAL AB RLD 1993-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019777-006 ZESTRIL 30MG TABLET / ORAL AB RLD 1999-01-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019777-001 ZESTRIL 5MG TABLET / ORAL AB RLD 1988-05-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019777-002 ZESTRIL 10MG TABLET / ORAL AB RLD 1988-05-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019777-003 ZESTRIL 20MG TABLET / ORAL AB RLD 1988-05-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019777-004 ZESTRIL 40MG TABLET / ORAL AB RLD, RS 1988-05-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019777-005 ZESTRIL 2.5MG TABLET / ORAL AB RLD 1993-04-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019777-006 ZESTRIL 30MG TABLET / ORAL AB RLD 1999-01-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019777-001 ZESTRIL 5MG TABLET / ORAL AB RLD 1988-05-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019777-002 ZESTRIL 10MG TABLET / ORAL AB RLD 1988-05-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019777-003 ZESTRIL 20MG TABLET / ORAL AB RLD 1988-05-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019777-004 ZESTRIL 40MG TABLET / ORAL AB RLD, RS 1988-05-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019777-005 ZESTRIL 2.5MG TABLET / ORAL AB RLD 1993-04-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019777-006 ZESTRIL 30MG TABLET / ORAL AB RLD 1999-01-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019777-001 ZESTRIL 5MG TABLET / ORAL AB RLD 1988-05-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019777-002 ZESTRIL 10MG TABLET / ORAL AB RLD 1988-05-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019777-003 ZESTRIL 20MG TABLET / ORAL AB RLD 1988-05-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019777-004 ZESTRIL 40MG TABLET / ORAL AB RLD, RS 1988-05-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019777-005 ZESTRIL 2.5MG TABLET / ORAL AB RLD 1993-04-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019777-006 ZESTRIL 30MG TABLET / ORAL AB RLD 1999-01-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019777-001 ZESTRIL 5MG TABLET / ORAL AB RLD 1988-05-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019777-002 ZESTRIL 10MG TABLET / ORAL AB RLD 1988-05-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019777-003 ZESTRIL 20MG TABLET / ORAL AB RLD 1988-05-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019777-004 ZESTRIL 40MG TABLET / ORAL AB RLD, RS 1988-05-19 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 252 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Zestril LISINOPRIL Upsher-Smith Laboratories, LLC 838c2d78-d2d8-4981-9ec9-e50ef9e1a5d8 2025-01-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 019777 application number: NDA019777
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 34 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 52427-438 Zestril Lisinopril Almatica Pharma Inc. NDA Current 52427-438 Zestril Lisinopril Almatica Pharma Inc. NDA Current 52427-438 Zestril Lisinopril Almatica Pharma LLC NDA Current 52427-438 Zestril Lisinopril Almatica Pharma LLC NDA Current 52427-438 Zestril Lisinopril Almatica Pharma LLC NDA Current 52427-439 Zestril Lisinopril Almatica Pharma Inc. NDA Current 52427-439 Zestril Lisinopril Almatica Pharma Inc. NDA Current 52427-439 Zestril Lisinopril Almatica Pharma LLC NDA Current 52427-439 Zestril Lisinopril Almatica Pharma LLC NDA Current 52427-439 Zestril Lisinopril Almatica Pharma LLC NDA Current 52427-440 Zestril Lisinopril Almatica Pharma Inc. NDA Current 52427-440 Zestril Lisinopril Almatica Pharma Inc. NDA Current 52427-440 Zestril Lisinopril Almatica Pharma LLC NDA Current 52427-440 Zestril Lisinopril Almatica Pharma LLC NDA Current 52427-440 Zestril Lisinopril Almatica Pharma LLC NDA Current 52427-441 Zestril Lisinopril Almatica Pharma Inc. NDA Current 52427-441 Zestril Lisinopril Almatica Pharma Inc. NDA Current 52427-441 Zestril Lisinopril Almatica Pharma LLC NDA Current 52427-441 Zestril Lisinopril Almatica Pharma LLC NDA Current 52427-441 Zestril Lisinopril Almatica Pharma LLC NDA Current 52427-442 Zestril Lisinopril Almatica Pharma Inc. NDA Current 52427-442 Zestril Lisinopril Almatica Pharma Inc. NDA Current 52427-442 Zestril Lisinopril Almatica Pharma LLC NDA Current 52427-442 Zestril Lisinopril Almatica Pharma LLC NDA Current 52427-442 Zestril Lisinopril Almatica Pharma LLC NDA Current 52427-443 Zestril Lisinopril Almatica Pharma Inc. NDA Current 52427-443 Zestril Lisinopril Almatica Pharma Inc. NDA Current 52427-443 Zestril Lisinopril Almatica Pharma LLC NDA Current 52427-443 Zestril Lisinopril Almatica Pharma LLC NDA Current 52427-443 Zestril Lisinopril Almatica Pharma LLC NDA Current 70518-1451 Zestril Lisinopril REMEDYREPACK INC. NDA Current 70518-1451 Zestril Lisinopril REMEDYREPACK INC. NDA Current 70518-1741 Zestril Lisinopril REMEDYREPACK INC. NDA Current 70518-1741 Zestril Lisinopril REMEDYREPACK INC. NDA Current