Lisinopril and Hydrochlorothiazide

Product NDC
82804-307
Requested package NDC
82804-307-30
11-digit product format
828040307
Labeler code
82804
Product ID
82804-307_5ee68045-a180-4d19-8d03-93074dbf7cd6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril and Hydrochlorothiazide Tablets
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA076230
Marketing category
ANDA
Marketing start
2015-03-12
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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
E7199S1YWRInternal UNII lookup
0J48LPH2THInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197885Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
43a4d6dd-bcca-412c-b051-ed470208ddb6Available on FDA.report

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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSREMEDYREPACK INC.3bea11a3-eb07-46b2-9b91-f8a48a2f3b7e2026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076230
application number: ANDA076230
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSProficient Rx LP43a4d6dd-bcca-412c-b051-ed470208ddb62026-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076230
application number: ANDA076230
ndc (package): 82804-307-30
ndc (product): 82804-307
ndc11 (package): 82804030730
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSSt. Mary's Medical Park Pharmacye1aa9682-b1ad-4a22-e053-2a95a90a0e2f2026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076230
application number: ANDA076230
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSSt. Mary's Medical Park Pharmacy00b266d9-ac4a-e931-e063-6294a90a6a0b2026-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076230
application number: ANDA076230
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSPreferred Pharmaceuticals Inc.5956a107-0f7b-49e7-b9c9-36790349b06e2026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076230
application number: ANDA076230
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSPreferred Pharmaceuticals Inc.9207c3bc-e12e-4017-8b85-0f928e744f642026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076230
application number: ANDA076230
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSPreferred Pharmaceuticals Inc.fc4d7d0e-78a6-4d7e-ba53-aeeb008aa2dc2026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076230
application number: ANDA076230
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSA-S Medication Solutions7d4ee5ec-5b68-453b-8d6e-214457a581592026-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076230
application number: ANDA076230
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSA-S Medication Solutions62e8c093-cd8e-4342-aadb-209c7e6699c82026-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076230
application number: ANDA076230
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSA-S Medication Solutionsc2396dd4-faf2-447c-bda5-2362dbbbe3522026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076230
application number: ANDA076230
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSA-S Medication Solutions22036b58-c1fe-45b5-ae08-93fdaf7165282026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076230
application number: ANDA076230
Lisinopril/HCTZLISINOPRIL/HCTZDirect_Rx4510c108-2683-f505-e063-6394a90ab0a42025-12-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076230
application number: ANDA076230
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSSolco Healthcare LLC96922ddc-e87f-4670-b22e-0ffd0d8f66e12025-07-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076230
application number: ANDA076230
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEAdvanced Rx Pharmacy of Tennessee, LLCecac0280-6faa-e7f3-e053-2995a90a2bd92024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076230
application number: ANDA076230
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSAphena Pharma Solutions - Tennessee, LLC2902430c-0bfe-483e-e063-6294a90a92d72024-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076230
application number: ANDA076230
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSBryant Ranch Prepackcafb049d-724f-4daa-b210-4be2cc1e4e692024-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076230
application number: ANDA076230
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSNuCare Pharmaceuticals,Inc.e0511312-0b07-be89-e053-2995a90ab1e52024-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076230
application number: ANDA076230
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSA-S Medication Solutions3372e46d-8f18-44fd-a9c8-3d8a45d9acdc2023-12-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076230
application number: ANDA076230
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSA-S Medication Solutionsed019adb-0a18-4aba-9b09-a0c966322d962023-12-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076230
application number: ANDA076230
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSBryant Ranch Prepack5885b1ff-715c-4f90-b43d-bddf94d61acd2023-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076230
application number: ANDA076230

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-307-308280403073030 TABLET in 1 BOTTLE (82804-307-30) 30 tablet2026-08-26NoNoCurrent