FDA.reportPublic FDA data

Lisinopril and Hydrochlorothiazide

Product NDC
68071-1945
Requested package NDC
68071-1945-8
11-digit product format
680711945
Labeler code
68071
Product ID
68071-1945_1d4bd9c2-3a4c-eef5-e063-6294a90adcc8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril and Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA077912
Marketing category
ANDA
Marketing start
2006-04-10
Substance
HYDROCHLOROTHIAZIDE; LISINOPRIL
Active strength
25; 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
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A077912-001LISINOPRIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LISINOPRIL12.5MG;10MGTABLET / ORALAB2006-09-27
A077912-002LISINOPRIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LISINOPRIL12.5MG;20MGTABLET / ORALAB2006-09-27
A077912-003LISINOPRIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LISINOPRIL25MG;20MGTABLET / ORALAB2006-09-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077912-001AB
A077912-002AB
A077912-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077912-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2006-09-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077912-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2006-09-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077912-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2006-09-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077912-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2006-09-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077912-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2006-09-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077912-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2006-09-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A077912-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2006-09-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077912-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2006-09-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077912-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2006-09-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077912-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2006-09-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077912-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2006-09-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077912-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2006-09-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077912-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2006-09-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077912-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2006-09-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077912-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2006-09-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077912-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2006-09-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077912-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2006-09-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077912-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2006-09-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077912-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2006-09-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077912-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2006-09-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077912-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2006-09-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077912-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2006-09-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077912-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2006-09-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077912-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2006-09-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077912-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2006-09-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077912-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2006-09-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077912-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2006-09-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077912-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2006-09-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A077912-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2006-09-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A077912-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2006-09-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077912-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2006-09-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077912-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2006-09-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077912-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2006-09-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077912-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2006-09-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077912-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2006-09-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077912-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2006-09-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077912-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2006-09-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077912-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2006-09-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077912-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2006-09-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077912-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2006-09-278072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077912-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077912-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077912-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077912-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077912-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077912-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077912-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077912-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077912-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077912-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077912-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077912-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077912-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077912-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077912-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077912-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077912-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077912-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077912-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077912-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077912-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077912-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077912-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077912-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077912-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077912-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077912-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077912-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077912-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077912-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077912-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077912-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077912-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077912-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077912-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077912-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077912-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077912-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077912-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077912-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Lisinopril and Hydrochlorothiazide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCHLOROTHIAZIDE25 mg/1
LISINOPRIL20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197887Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4925a3ad-63bd-108a-e054-00144ff8d46cAvailable on FDA.report

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
68071-1945-22024-07-15LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS USP
68071-1945-32024-07-15LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS USP
68071-1945-62024-07-15LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS USP
68071-1945-82024-07-15LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS USP
68071-1945-92024-07-15LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS USP
68071-1945-22023-01-30LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS USP
68071-1945-32023-01-30LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS USP
68071-1945-62023-01-30LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS USP
68071-1945-82023-01-30LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS USP
68071-1945-92023-01-30LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS USP
68071-1945-22021-02-23LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS USP
68071-1945-32021-02-23LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS USP
68071-1945-62021-02-23LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS USP
68071-1945-92021-02-23LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS USP
68071-1945-22021-01-29LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS USP
68071-1945-32021-01-29LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS USP
68071-1945-62021-01-29LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS USP
68071-1945-92021-01-29LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-1945-2Lisinopril and Hydrochlorothiazide20 in 1 BOTTLETABLET206
68071-1945-3Lisinopril and Hydrochlorothiazide30 in 1 BOTTLETABLET306
68071-1945-6Lisinopril and Hydrochlorothiazide60 in 1 BOTTLETABLET606
68071-1945-8Lisinopril and Hydrochlorothiazide180 in 1 BOTTLETABLET1806
68071-1945-9Lisinopril and Hydrochlorothiazide90 in 1 BOTTLETABLET906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-1945LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [NUCARE PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 5 package rows20240716_4925a3ad-63bd-108a-e054-00144ff8d46c.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 2 · 27 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.3857ac53-0435-4d68-8066-c222914148892026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077912
application number: ANDA077912
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.868b1442-c412-4ee8-9798-f2408cd2249a2026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077912
application number: ANDA077912
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.408e797a-2cf3-4ee6-9f9b-179a8cf3d7992026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077912
application number: ANDA077912
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDECoupler LLC52b90789-2902-3ab9-e063-6394a90a5abb2026-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077912
application number: ANDA077912
LISINOPRIL AND HYDROCHLOROTHIAZIDELISINOPRIL AND HYDROCHLOROTHIAZIDEPreferred Pharmaceuticals, Inc.5aa18b0b-4688-493a-a5ae-cb056ea6c0e32026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077912
application number: ANDA077912
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack544b75eb-55f1-4164-9b83-39f6bc5fb4792026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077912
application number: ANDA077912
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack019ac336-0dc3-ec89-3e0a-09110e0fc30b2026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077912
application number: ANDA077912
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEBryant Ranch Prepackeac8c44f-cf77-6a30-cfd7-7cffffc79bd62026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077912
application number: ANDA077912
LISINOPRIL AND HYDROCHLOROTHIAZIDELISINOPRIL AND HYDROCHLOROTHIAZIDESt Marys Medical Park Pharmacye7b68ea6-4fc8-441a-9640-1ccd3a482d8e2026-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077912
application number: ANDA077912
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDELegacy Pharmaceutical Packaging, LLC6d729ec5-7311-4534-9999-9d6fa4f3ba2f2026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077912
application number: ANDA077912
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEPD-Rx Pharmaceuticals, Inc.8808879d-8c7e-45d1-8a49-c05d2cf845d32026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077912
application number: ANDA077912
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEPD-Rx Pharmaceuticals, Inc.00f67e1a-6999-4295-9c9f-fcb1ce9711b82026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077912
application number: ANDA077912
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEPD-Rx Pharmaceuticals, Inc.ec23c75d-68d5-46d0-be56-b96ddba19ed62026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077912
application number: ANDA077912
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDENorthwind Health Company, LLCf2b94985-c79d-40e3-e053-2a95a90a0d782026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077912
application number: ANDA077912
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDENorthwind Health Company, LLCc97e38f2-7163-4d4e-a694-4d0612423e532026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077912
application number: ANDA077912
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDENorthwind Health Company, LLC3984e6b9-2d88-47f0-af09-cce428bba14f2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077912
application number: ANDA077912
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEQPharma, Inc.c80b2164-3795-6668-e053-2a95a90a4d452025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077912
application number: ANDA077912
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDELupin Pharmaceuticals, Inc.515f735c-5dba-43d9-8a58-97a319cafd562025-11-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077912
application number: ANDA077912
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEA-S Medication Solutionscd62e287-b648-459a-9414-621686c6b6072025-11-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077912
application number: ANDA077912
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEA-S Medication Solutions316e9226-e63e-466d-8143-f1edc7288fca2025-11-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077912
application number: ANDA077912

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197887lisinopril 20 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN4925a3ad-63bd-108a-e054-00144ff8d46c6
197887hydrochlorothiazide 25 MG / lisinopril 20 MG Oral TabletSCD4925a3ad-63bd-108a-e054-00144ff8d46c6
197887HCTZ 25 MG / lisinopril 20 MG Oral TabletSY4925a3ad-63bd-108a-e054-00144ff8d46c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-1945-868071194508180 TABLET in 1 BOTTLE (68071-1945-8) 180 tablet2017-02-220000-00-00NoNoCurrent