Lisinopril and Hydrochlorothiazide

Product NDC
0615-7582
11-digit product format
006157582
Labeler code
0615
Product ID
0615-7582_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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0615-7582DDiscontinued by firm2026-10-12
excluded packagepackage0615-75820615-7582-39DDiscontinued by firm2026-10-12

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 dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0615-7582-39DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0615-7582-39DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0615-7582-39DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0615-7582-39DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0615-7582-39DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0615-7582-39DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0615-7582-39DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0615-7582-39DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0615-7582-39DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0615-7582-39DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0615-7582-39DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0615-7582-39DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage0615-7582-39IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage0615-7582-39IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage0615-7582-39EExcluded after deficient or non-compliant submission was not corrected110d247fa046…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075776-001LISINOPRIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LISINOPRIL12.5MG;10MGTABLET / ORAL2002-07-01
A075776-002LISINOPRIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LISINOPRIL12.5MG;20MGTABLET / ORAL2002-07-01
A075776-003LISINOPRIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LISINOPRIL25MG;20MGTABLET / ORAL2002-07-01

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A075776-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORAL2002-07-0184e616aacf4f…
2026-09-14 22:38:342026-08A075776-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORAL2002-07-0184e616aacf4f…
2026-09-14 22:38:342026-08A075776-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORAL2002-07-0184e616aacf4f…
2026-08-18 06:07:402026-07A075776-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORAL2002-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A075776-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORAL2002-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A075776-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORAL2002-07-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075776-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORAL2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075776-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORAL2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075776-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORAL2002-07-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075776-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORAL2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075776-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORAL2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075776-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORAL2002-07-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075776-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORAL2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075776-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORAL2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075776-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORAL2002-07-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075776-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORAL2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075776-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORAL2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075776-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORAL2002-07-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075776-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORAL2002-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075776-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORAL2002-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075776-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORAL2002-07-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075776-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORAL2002-07-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075776-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORAL2002-07-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075776-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORAL2002-07-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075776-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORAL2002-07-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075776-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORAL2002-07-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075776-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORAL2002-07-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075776-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORAL2002-07-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075776-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORAL2002-07-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075776-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORAL2002-07-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075776-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORAL2002-07-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075776-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORAL2002-07-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075776-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORAL2002-07-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075776-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORAL2002-07-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A075776-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORAL2002-07-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A075776-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORAL2002-07-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075776-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORAL2002-07-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075776-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORAL2002-07-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075776-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORAL2002-07-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075776-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORAL2002-07-01301d65b070ca…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-07-19 19:46 UTC2019-07A075776-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A075776-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A075776-003AB1ea99ee380514…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0615-7582-392021-07-08C16284748780-19d75b9d1-0b94-f424-e053-dadaa90a57ceLisinopril and Hydrochlorothiazide
0615-7582-392020-01-31C16284748780-19d75b9d1-0b94-f424-e053-dadaa90a57ceLisinopril and Hydrochlorothiazide

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]13
LISINOPRILACTIVE INGREDIENTE7199S1YWRLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]13
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]13
LISINOPRIL ANHYDROUSACTIVE MOIETY7Q3P4BS2FDLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]13
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]13
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]13
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]13
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]13
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]13
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]13
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]13
MANNITOLINACTIVE INGREDIENT3OWL53L36ALISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]13
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]13
TALCINACTIVE INGREDIENT7SEV7J4R1ULISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]13