Home Applications 019851 Application 019851
Type NDA
Sponsor US PHARMS HOLDINGS I Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LOTENSIN BENAZEPRIL HYDROCHLORIDE TABLET;ORAL 5MG Yes No 002 LOTENSIN BENAZEPRIL HYDROCHLORIDE TABLET;ORAL 10MG Yes No 003 LOTENSIN BENAZEPRIL HYDROCHLORIDE TABLET;ORAL 20MG Yes No 004 LOTENSIN BENAZEPRIL HYDROCHLORIDE TABLET;ORAL 40MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019851-001 LOTENSIN BENAZEPRIL HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-06-25 N019851-002 LOTENSIN BENAZEPRIL HYDROCHLORIDE 10MG TABLET / ORAL AB RLD 1991-06-25 N019851-003 LOTENSIN BENAZEPRIL HYDROCHLORIDE 20MG TABLET / ORAL AB RLD 1991-06-25 N019851-004 LOTENSIN BENAZEPRIL HYDROCHLORIDE 40MG TABLET / ORAL AB RLD 1991-06-25
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 5 · 168 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 N019851-001 LOTENSIN 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-06-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019851-002 LOTENSIN 10MG TABLET / ORAL AB RLD 1991-06-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019851-003 LOTENSIN 20MG TABLET / ORAL AB RLD 1991-06-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019851-004 LOTENSIN 40MG TABLET / ORAL AB RLD 1991-06-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019851-001 LOTENSIN 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-06-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019851-002 LOTENSIN 10MG TABLET / ORAL AB RLD 1991-06-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019851-003 LOTENSIN 20MG TABLET / ORAL AB RLD 1991-06-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019851-004 LOTENSIN 40MG TABLET / ORAL AB RLD 1991-06-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019851-001 LOTENSIN 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-06-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019851-002 LOTENSIN 10MG TABLET / ORAL AB RLD 1991-06-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019851-003 LOTENSIN 20MG TABLET / ORAL AB RLD 1991-06-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019851-004 LOTENSIN 40MG TABLET / ORAL AB RLD 1991-06-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019851-001 LOTENSIN 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-06-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019851-002 LOTENSIN 10MG TABLET / ORAL AB RLD 1991-06-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019851-003 LOTENSIN 20MG TABLET / ORAL AB RLD 1991-06-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019851-004 LOTENSIN 40MG TABLET / ORAL AB RLD 1991-06-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019851-001 LOTENSIN 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-06-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019851-002 LOTENSIN 10MG TABLET / ORAL AB RLD 1991-06-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019851-003 LOTENSIN 20MG TABLET / ORAL AB RLD 1991-06-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019851-004 LOTENSIN 40MG TABLET / ORAL AB RLD 1991-06-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019851-001 LOTENSIN 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-06-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019851-002 LOTENSIN 10MG TABLET / ORAL AB RLD 1991-06-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019851-003 LOTENSIN 20MG TABLET / ORAL AB RLD 1991-06-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019851-004 LOTENSIN 40MG TABLET / ORAL AB RLD 1991-06-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019851-001 LOTENSIN 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-06-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019851-002 LOTENSIN 10MG TABLET / ORAL AB RLD 1991-06-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019851-003 LOTENSIN 20MG TABLET / ORAL AB RLD 1991-06-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019851-004 LOTENSIN 40MG TABLET / ORAL AB RLD 1991-06-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019851-001 LOTENSIN 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-06-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019851-002 LOTENSIN 10MG TABLET / ORAL AB RLD 1991-06-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019851-003 LOTENSIN 20MG TABLET / ORAL AB RLD 1991-06-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019851-004 LOTENSIN 40MG TABLET / ORAL AB RLD 1991-06-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019851-001 LOTENSIN 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-06-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019851-002 LOTENSIN 10MG TABLET / ORAL AB RLD 1991-06-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019851-003 LOTENSIN 20MG TABLET / ORAL AB RLD 1991-06-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019851-004 LOTENSIN 40MG TABLET / ORAL AB RLD 1991-06-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019851-001 LOTENSIN 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-06-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019851-002 LOTENSIN 10MG TABLET / ORAL AB RLD 1991-06-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019851-003 LOTENSIN 20MG TABLET / ORAL AB RLD 1991-06-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019851-004 LOTENSIN 40MG TABLET / ORAL AB RLD 1991-06-25 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 139 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 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 30698-448 Lotensin benazepril hydrochloride Validus Pharmaceuticals LLC NDA Current 30698-448 Lotensin benazepril hydrochloride Validus Pharmaceuticals LLC NDA Current 30698-448 Lotensin benazepril hydrochloride Validus Pharmaceuticals LLC NDA Current 30698-449 Lotensin benazepril hydrochloride Validus Pharmaceuticals LLC NDA Current 30698-449 Lotensin benazepril hydrochloride Validus Pharmaceuticals LLC NDA Current 30698-449 Lotensin benazepril hydrochloride Validus Pharmaceuticals LLC NDA Current 30698-450 Lotensin benazepril hydrochloride Validus Pharmaceuticals LLC NDA Current 30698-450 Lotensin benazepril hydrochloride Validus Pharmaceuticals LLC NDA Current 30698-450 Lotensin benazepril hydrochloride Validus Pharmaceuticals LLC NDA Current