Home NDC 10544-585 Lisinopril
Product NDC 10544-585
11-digit product format 105440585
Labeler code 10544
Product ID 10544-585_10ddc30d-bacc-1c74-e054-00144ff8d46c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lisinopril
Dosage form TABLET
Route ORAL
Labeler Blenheim Pharmacal, Inc.
Application ANDA075743
Marketing category ANDA
Marketing start 2014-02-28
Marketing end 0000-00-00
Substance LISINOPRIL
Active strength 5 mg/1
Pharmacologic classes Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record 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 · 44 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 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 10544-585-30 I Inactivated by FDA d630ba8d3edf…732f749b63fb…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 10544-585-30 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 10544-585-30 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 10544-585-30 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 10544-585-30 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 10544-585-30 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 10544-585-30 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 10544-585-30 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 10544-585-30 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 10544-585-30 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 10544-585-30 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 10544-585-30 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 10544-585-30 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 10544-585-30 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 10544-585-30 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 10544-585-30 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 10544-585-30 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 10544-585-30 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 10544-585-30 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 10544-585-30 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 10544-585-30 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 10544-585-30 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 A075743-001 LISINOPRIL LISINOPRIL 2.5MG TABLET / ORAL AB 2002-07-01 A075743-002 LISINOPRIL LISINOPRIL 5MG TABLET / ORAL AB 2002-07-01 A075743-003 LISINOPRIL LISINOPRIL 10MG TABLET / ORAL AB 2002-07-01 A075743-004 LISINOPRIL LISINOPRIL 20MG TABLET / ORAL AB 2002-07-01 A075743-005 LISINOPRIL LISINOPRIL 30MG TABLET / ORAL AB 2002-07-01 A075743-006 LISINOPRIL LISINOPRIL 40MG TABLET / ORAL AB 2002-07-01
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 A075743-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2002-07-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075743-002 LISINOPRIL 5MG TABLET / ORAL AB 2002-07-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075743-003 LISINOPRIL 10MG TABLET / ORAL AB 2002-07-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075743-004 LISINOPRIL 20MG TABLET / ORAL AB 2002-07-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075743-005 LISINOPRIL 30MG TABLET / ORAL AB 2002-07-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075743-006 LISINOPRIL 40MG TABLET / ORAL AB 2002-07-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075743-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2002-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075743-002 LISINOPRIL 5MG TABLET / ORAL AB 2002-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075743-003 LISINOPRIL 10MG TABLET / ORAL AB 2002-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075743-004 LISINOPRIL 20MG TABLET / ORAL AB 2002-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075743-005 LISINOPRIL 30MG TABLET / ORAL AB 2002-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075743-006 LISINOPRIL 40MG TABLET / ORAL AB 2002-07-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075743-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2002-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075743-002 LISINOPRIL 5MG TABLET / ORAL AB 2002-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075743-003 LISINOPRIL 10MG TABLET / ORAL AB 2002-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075743-004 LISINOPRIL 20MG TABLET / ORAL AB 2002-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075743-005 LISINOPRIL 30MG TABLET / ORAL AB 2002-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075743-006 LISINOPRIL 40MG TABLET / ORAL AB 2002-07-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075743-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2002-07-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075743-002 LISINOPRIL 5MG TABLET / ORAL AB 2002-07-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075743-003 LISINOPRIL 10MG TABLET / ORAL AB 2002-07-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075743-004 LISINOPRIL 20MG TABLET / ORAL AB 2002-07-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075743-005 LISINOPRIL 30MG TABLET / ORAL AB 2002-07-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075743-006 LISINOPRIL 40MG TABLET / ORAL AB 2002-07-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075743-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2002-07-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075743-002 LISINOPRIL 5MG TABLET / ORAL AB 2002-07-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075743-003 LISINOPRIL 10MG TABLET / ORAL AB 2002-07-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075743-004 LISINOPRIL 20MG TABLET / ORAL AB 2002-07-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075743-005 LISINOPRIL 30MG TABLET / ORAL AB 2002-07-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075743-006 LISINOPRIL 40MG TABLET / ORAL AB 2002-07-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075743-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2002-07-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075743-002 LISINOPRIL 5MG TABLET / ORAL AB 2002-07-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075743-003 LISINOPRIL 10MG TABLET / ORAL AB 2002-07-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075743-004 LISINOPRIL 20MG TABLET / ORAL AB 2002-07-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075743-005 LISINOPRIL 30MG TABLET / ORAL AB 2002-07-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075743-006 LISINOPRIL 40MG TABLET / ORAL AB 2002-07-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075743-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2002-07-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075743-002 LISINOPRIL 5MG TABLET / ORAL AB 2002-07-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075743-003 LISINOPRIL 10MG TABLET / ORAL AB 2002-07-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075743-004 LISINOPRIL 20MG TABLET / ORAL AB 2002-07-01 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 252 observed states.
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 10544-585-30 Lisinopril 30 in 1 BOTTLE TABLET 30 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LISINOPRIL ACTIVE INGREDIENT E7199S1YWR LISINOPRIL TABLET [BLENHEIM PHARMACAL, INC.] 2 LISINOPRIL ANHYDROUS ACTIVE MOIETY 7Q3P4BS2FD LISINOPRIL TABLET [BLENHEIM PHARMACAL, INC.] 2 CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP LISINOPRIL TABLET [BLENHEIM PHARMACAL, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LISINOPRIL TABLET [BLENHEIM PHARMACAL, INC.] 2 MANNITOL INACTIVE INGREDIENT 3OWL53L36A LISINOPRIL TABLET [BLENHEIM PHARMACAL, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LISINOPRIL TABLET [BLENHEIM PHARMACAL, INC.] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U LISINOPRIL TABLET [BLENHEIM PHARMACAL, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10544-585 LISINOPRIL TABLET [BLENHEIM PHARMACAL, INC.] 2 Legacy NDC, 1 package rows 20150309_a1106697-db02-4e59-a60d-555edbf3dd6f.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lisinopril LISINOPRIL PD-Rx Pharmaceuticals, Inc. b62815f3-77fc-4074-a28a-918ab5cc32db 2025-10-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075743 application number: ANDA075743 Lisinopril LISINOPRIL Aphena Pharma Solutions - Tennessee, LLC a79a034d-7bbb-4b05-b8fc-8ebf09f33c0c 2023-10-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075743 application number: ANDA075743 Lisinopril LISINOPRIL Solco healthcare U.S., LLC f8d16c85-50e2-4d99-afae-6fb902734e42 2022-06-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075743 application number: ANDA075743 Lisinopril LISINOPRIL Aphena Pharma Solutions - Tennessee, LLC 1c0250c7-ff57-411b-852b-b8e4573f2057 2020-04-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075743 application number: ANDA075743
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 10544-585-30 10544058530 30 in 1 BOTTLE Historical