Home NDC 30698-450 Lotensin
Product NDC 30698-450
11-digit product format 306980450
Labeler code 30698
Product ID 30698-450_40029d07-adfa-0cc3-e063-6294a90a4cd5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name benazepril hydrochloride
Dosage form TABLET
Route ORAL
Labeler Validus Pharmaceuticals LLC
Application NDA019851
Marketing category NDA
Marketing start 1991-06-21
Substance BENAZEPRIL HYDROCHLORIDE
Active strength 40 mg/1
Pharmacologic classes Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 16 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 30698-450-01 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 30698-450-01 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 30698-450-01 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 30698-450-01 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 30698-450-01 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 30698-450-01 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 30698-450-01 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 30698-450-01 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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.
Additional Listing Data#
Finished product Yes
Brand name base Lotensin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENAZEPRIL HYDROCHLORIDE 40 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination N1SN99T69T Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 898687 Internal RxNorm lookup 898689 Internal RxNorm lookup 898690 Internal RxNorm lookup 898692 Internal RxNorm lookup 898719 Internal RxNorm lookup 898721 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 30698-450-01 Lotensin 100 in 1 BOTTLE TABLET 100 10
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 30698-450 LOTENSIN (BENAZEPRIL HYDROCHLORIDE) TABLET [VALIDUS PHARMACEUTICALS LLC] 9 Current NDC, Legacy NDC, 1 package rows 20230219_2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e.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 Lotensin BENAZEPRIL HYDROCHLORIDE Validus Pharmaceuticals LLC 2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e 2025-09-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 019851 application number: NDA019851 ndc (product): 30698-450
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 30698-450-01 30698045001 100 TABLET in 1 BOTTLE (30698-450-01) 100 tablet 1991-06-21 0000-00-00 No No Current