Lisinopril and Hydrochlorothiazide

Product NDC
43547-422
Requested package NDC
43547-422-11
11-digit product format
435470422
Labeler code
43547
Product ID
43547-422_aa807721-e199-4e66-a188-a034be14f6a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril and Hydrochlorothiazide Tablets
Dosage form
TABLET
Route
ORAL
Labeler
Solco Healthcare LLC
Application
ANDA076230
Marketing category
ANDA
Marketing start
2015-03-12
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

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
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 · 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 UTC2026-02A076230-001LISINOPRIL 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…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076230-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2002-07-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076230-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2002-07-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076230-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2002-07-011e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076230-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2002-07-011e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076230-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2002-07-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076230-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2002-07-018072bd15b7f6…

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 UTC2026-02A076230-001AB1011fe1cb6892…
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…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076230-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076230-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076230-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076230-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076230-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076230-001AB18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LISINOPRIL25 mg/1
HYDROCHLOROTHIAZIDE20 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197885Internal RxNorm lookup
197886Internal RxNorm lookup
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
96922ddc-e87f-4670-b22e-0ffd0d8f66e1Available 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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43547-422-10Lisinopril and Hydrochlorothiazide100 in 1 BOTTLETABLET1004
43547-422-11Lisinopril and Hydrochlorothiazide1000 in 1 BOTTLETABLET10004
43547-422-50Lisinopril and Hydrochlorothiazide500 in 1 BOTTLETABLET5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-422-10EA - Each43547-4220978c609-093f-47ea-b4dc-0e4ec812668812018-06-11
43547-422-50EA - Each43547-422ffbbb720-8e8f-47da-8bb7-486ab8bd3a1812018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-422LISINOPRIL AND HYDROCHLOROTHIAZIDE (LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS) TABLET [SOLCO HEALTHCARE LLC]2Current NDC, Legacy NDC, 3 package rows20200529_96922ddc-e87f-4670-b22e-0ffd0d8f66e1.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 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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 TABLETSREMEDYREPACK INC.d383e0e5-4e00-44cc-9d6f-86e76f4e79e32026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076230
application number: ANDA076230
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSREMEDYREPACK INC.3bea11a3-eb07-46b2-9b91-f8a48a2f3b7e2026-04-10Boxed 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
ndc (package): 43547-422-11
ndc (product): 43547-422
ndc11 (package): 43547042211
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197887lisinopril 20 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN5885b1ff-715c-4f90-b43d-bddf94d61acd101
197887hydrochlorothiazide 25 MG / lisinopril 20 MG Oral TabletSCD5885b1ff-715c-4f90-b43d-bddf94d61acd101
197887HCTZ 25 MG / lisinopril 20 MG Oral TabletSY5885b1ff-715c-4f90-b43d-bddf94d61acd101
197887lisinopril 20 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNc2396dd4-faf2-447c-bda5-2362dbbbe3528
197887lisinopril 20 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN22036b58-c1fe-45b5-ae08-93fdaf7165288
197887hydrochlorothiazide 25 MG / lisinopril 20 MG Oral TabletSCD22036b58-c1fe-45b5-ae08-93fdaf7165288
197887hydrochlorothiazide 25 MG / lisinopril 20 MG Oral TabletSCDc2396dd4-faf2-447c-bda5-2362dbbbe3528
197887HCTZ 25 MG / lisinopril 20 MG Oral TabletSY22036b58-c1fe-45b5-ae08-93fdaf7165288
197887HCTZ 25 MG / lisinopril 20 MG Oral TabletSYc2396dd4-faf2-447c-bda5-2362dbbbe3528
197887lisinopril 20 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN5956a107-0f7b-49e7-b9c9-36790349b06e5
197887hydrochlorothiazide 25 MG / lisinopril 20 MG Oral TabletSCD5956a107-0f7b-49e7-b9c9-36790349b06e5
197887HCTZ 25 MG / lisinopril 20 MG Oral TabletSY5956a107-0f7b-49e7-b9c9-36790349b06e5
197885lisinopril 10 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN96922ddc-e87f-4670-b22e-0ffd0d8f66e14
197886lisinopril 20 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN96922ddc-e87f-4670-b22e-0ffd0d8f66e14
197887lisinopril 20 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN96922ddc-e87f-4670-b22e-0ffd0d8f66e14
197885hydrochlorothiazide 12.5 MG / lisinopril 10 MG Oral TabletSCD96922ddc-e87f-4670-b22e-0ffd0d8f66e14
197886hydrochlorothiazide 12.5 MG / lisinopril 20 MG Oral TabletSCD96922ddc-e87f-4670-b22e-0ffd0d8f66e14
197887hydrochlorothiazide 25 MG / lisinopril 20 MG Oral TabletSCD96922ddc-e87f-4670-b22e-0ffd0d8f66e14
197885HCTZ 12.5 MG / lisinopril 10 MG Oral TabletSY96922ddc-e87f-4670-b22e-0ffd0d8f66e14
197886HCTZ 12.5 MG / lisinopril 20 MG Oral TabletSY96922ddc-e87f-4670-b22e-0ffd0d8f66e14
197887HCTZ 25 MG / lisinopril 20 MG Oral TabletSY96922ddc-e87f-4670-b22e-0ffd0d8f66e14
197887lisinopril 20 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNe0511312-0b07-be89-e053-2995a90ab1e53
197887hydrochlorothiazide 25 MG / lisinopril 20 MG Oral TabletSCDe0511312-0b07-be89-e053-2995a90ab1e53
197887HCTZ 25 MG / lisinopril 20 MG Oral TabletSYe0511312-0b07-be89-e053-2995a90ab1e53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43547-422-11435470422111000 TABLET in 1 BOTTLE (43547-422-11) 1000 tablet2015-03-120000-00-00NoNoCurrent