FDA.reportPublic FDA data

Lisinopril and Hydrochlorothiazide

Product NDC
60760-586
11-digit product format
607600586
Labeler code
60760
Product ID
60760-586_5cceb143-333c-6789-e063-6394a90a50ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril and Hydrochlorothiazide Tablets
Dosage form
TABLET
Route
ORAL
Labeler
St. Mary's Medical Park Pharmacy
Application
ANDA076230
Marketing category
ANDA
Marketing start
2023-06-29
Substance
LISINOPRIL; HYDROCHLOROTHIAZIDE
Active strength
10; 12.5 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
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
A076230-001LISINOPRIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LISINOPRIL12.5MG;10MGTABLET / ORALAB2002-07-01
A076230-002LISINOPRIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LISINOPRIL12.5MG;20MGTABLET / ORALAB2002-07-01
A076230-003LISINOPRIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LISINOPRIL25MG;20MGTABLET / ORALAB2002-07-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A076230-001AB
A076230-002AB
A076230-003AB

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 22:38:342026-08A076230-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2002-07-0184e616aacf4f…
2026-09-14 22:38:342026-08A076230-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2002-07-0184e616aacf4f…
2026-09-14 22:38:342026-08A076230-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2002-07-0184e616aacf4f…
2026-08-18 06:07:402026-07A076230-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2002-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A076230-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2002-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A076230-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2002-07-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076230-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076230-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076230-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2002-07-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076230-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076230-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076230-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2002-07-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076230-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076230-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076230-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2002-07-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076230-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076230-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076230-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2002-07-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076230-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2002-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076230-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2002-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076230-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2002-07-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076230-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2002-07-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076230-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2002-07-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076230-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2002-07-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076230-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2002-07-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076230-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2002-07-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076230-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2002-07-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076230-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2002-07-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076230-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2002-07-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076230-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2002-07-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076230-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2002-07-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076230-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2002-07-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076230-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2002-07-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076230-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2002-07-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A076230-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2002-07-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A076230-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2002-07-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076230-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2002-07-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076230-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2002-07-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076230-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2002-07-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076230-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2002-07-01301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A076230-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A076230-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A076230-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A076230-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076230-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076230-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076230-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076230-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076230-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076230-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076230-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076230-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076230-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076230-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076230-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076230-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076230-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076230-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076230-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076230-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076230-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076230-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076230-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076230-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076230-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076230-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076230-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076230-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076230-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076230-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076230-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076230-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076230-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076230-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076230-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076230-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076230-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076230-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076230-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076230-001AB1301d65b070ca…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Lisinopril and Hydrochlorothiazide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LISINOPRIL10 mg/1
HYDROCHLOROTHIAZIDE12.5 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
1199f4b7-b537-466c-9a1c-cb09131e9f8bProduct name120251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
f8f05a6d-f74b-4e9e-ab1c-374d3b4fb820Product name120230703
162cbc9d-ecc3-72ba-af9f-c76e2756ef54Product name320221207
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110
f65307a7-3644-0a09-cdfd-94aae8d3b53eProduct name320210902
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
89a57420-ab44-5323-14f9-595159145f9bProduct name220190612
c27b049d-3258-48cf-ebe5-08c236ae78e2Product name320190610
00fc2cf9-672f-3e0b-6afa-43cbc864d058Product name420180613
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
ea069444-e874-4c28-833f-d2f52734ef4dProduct name120150206
041df61b-f8b6-48a6-7b67-411e1412678bProduct name120140508
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508
433a3439-b8f3-d13a-d2c8-9b221d628d60Product name120140508
59212689-39e5-a976-6d21-882d76d8079aProduct name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
df89bd47-2db4-d593-ab37-d11953fd5536Product name120140508
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60760-586-90Lisinopril and Hydrochlorothiazide90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-586-90EA - Each60760-58612a5f329-2142-4cc0-8643-5b8a6b1e385b12023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-586LISINOPRIL AND HYDROCHLOROTHIAZIDE (LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS) TABLET [ST. MARY'S MEDICAL PARK PHARMACY]1Current NDC, 1 package rows20230718_00b266d9-ac4a-e931-e063-6294a90a6a0b.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 2 of 2 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSBryant Ranch Prepackb7d6f322-6415-4952-a2d4-7f46aca8af9d2023-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076230
application number: ANDA076230
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSProficient Rx LP84dba61d-cae2-4f21-9a9e-3088f356f8382023-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076230
application number: ANDA076230

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197885lisinopril 10 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN00b266d9-ac4a-e931-e063-6294a90a6a0b1
197885hydrochlorothiazide 12.5 MG / lisinopril 10 MG Oral TabletSCD00b266d9-ac4a-e931-e063-6294a90a6a0b1
197885HCTZ 12.5 MG / lisinopril 10 MG Oral TabletSY00b266d9-ac4a-e931-e063-6294a90a6a0b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60760-586-906076005869090 TABLET in 1 BOTTLE, PLASTIC (60760-586-90) 90 tablet2023-06-29NoNoCurrent