Home NDC 0615-7577 Lisinopril and Hydrochlorothiazide
Product NDC 0615-7577
11-digit product format 006157577
Labeler code 0615
Product ID 0615-7577_73ba838d-7be2-4fbf-b307-3ce8f6db4210
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lisinopril and Hydrochlorothiazide
Dosage form TABLET
Route ORAL
Labeler NCS HealthCare of KY, Inc dba Vangard Labs
Application ANDA075776
Marketing category ANDA
Marketing start 2011-09-13
Marketing end 0000-00-00
Substance LISINOPRIL; HYDROCHLOROTHIAZIDE
Active strength 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 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 · 30 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 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0615-7577-39 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0615-7577-39 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0615-7577-39 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0615-7577-39 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0615-7577-39 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0615-7577-39 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0615-7577-39 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0615-7577-39 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0615-7577-39 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0615-7577-39 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0615-7577-39 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0615-7577-39 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…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 0615-7577-39 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 0615-7577-39 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 0615-7577-39 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A075776-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;10MG TABLET / ORAL 2002-07-01 A075776-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;20MG TABLET / ORAL 2002-07-01 A075776-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 25MG;20MG TABLET / ORAL 2002-07-01
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 · 129 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 2026-09-14 22:38:34 2026-08 A075776-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL 2002-07-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075776-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL 2002-07-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075776-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL 2002-07-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075776-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL 2002-07-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075776-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL 2002-07-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075776-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL 2002-07-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075776-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL 2002-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075776-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL 2002-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075776-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL 2002-07-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075776-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL 2002-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075776-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL 2002-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075776-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL 2002-07-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075776-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL 2002-07-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075776-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL 2002-07-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075776-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL 2002-07-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075776-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL 2002-07-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075776-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL 2002-07-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075776-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL 2002-07-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075776-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL 2002-07-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075776-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL 2002-07-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075776-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL 2002-07-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075776-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL 2002-07-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075776-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL 2002-07-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075776-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL 2002-07-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075776-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL 2002-07-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075776-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL 2002-07-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075776-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL 2002-07-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075776-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL 2002-07-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075776-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL 2002-07-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075776-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL 2002-07-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075776-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL 2002-07-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075776-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL 2002-07-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075776-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL 2002-07-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075776-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL 2002-07-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075776-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL 2002-07-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075776-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL 2002-07-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075776-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL 2002-07-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075776-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL 2002-07-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075776-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL 2002-07-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075776-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL 2002-07-01 301d65b070ca…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDROCHLOROTHIAZIDE ACTIVE INGREDIENT 0J48LPH2TH LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 13 LISINOPRIL ACTIVE INGREDIENT E7199S1YWR LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 13 HYDROCHLOROTHIAZIDE ACTIVE MOIETY 0J48LPH2TH LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 13 LISINOPRIL ANHYDROUS ACTIVE MOIETY 7Q3P4BS2FD LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 13 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 13 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 13 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 13 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 13 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 13 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 13 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 13 MANNITOL INACTIVE INGREDIENT 3OWL53L36A LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 13 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 13 TALC INACTIVE INGREDIENT 7SEV7J4R1U LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 13