Lisinopril and Hydrochlorothiazide

Product NDC
50090-1108
Requested package NDC
50090-1108-0
11-digit product format
500901108
Labeler code
50090
Product ID
50090-1108_4f4c3e61-c167-4c37-bc6d-a80e0eee08ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril and Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076194
Marketing category
ANDA
Marketing start
2003-03-04
Marketing end
0000-00-00
Substance
LISINOPRIL; HYDROCHLOROTHIAZIDE
Active strength
20 mg/1; mg/1
Pharmacologic classes
Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-110850090-1108-0DDiscontinued by firm2026-08-03

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
A076194-001LISINOPRIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LISINOPRIL12.5MG;20MGTABLET / ORALAB2002-07-01
A076194-002LISINOPRIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LISINOPRIL25MG;20MGTABLET / ORALAB2002-07-01
A076194-003LISINOPRIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LISINOPRIL12.5MG;10MGTABLET / 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
A076194-001AB
A076194-002AB
A076194-003AB

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 UTC2026-02A076194-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076194-002LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076194-003LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2002-07-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076194-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076194-002LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076194-003LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2002-07-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076194-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076194-002LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076194-003LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2002-07-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076194-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076194-002LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076194-003LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2002-07-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076194-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2002-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076194-002LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2002-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076194-003LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2002-07-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076194-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2002-07-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076194-002LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2002-07-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076194-003LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2002-07-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076194-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2002-07-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076194-002LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2002-07-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076194-003LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2002-07-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076194-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2002-07-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076194-002LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2002-07-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076194-003LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2002-07-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076194-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2002-07-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076194-002LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2002-07-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076194-003LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2002-07-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076194-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2002-07-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A076194-002LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2002-07-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A076194-003LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2002-07-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076194-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2002-07-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076194-002LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2002-07-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076194-003LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2002-07-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076194-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2002-07-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076194-002LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2002-07-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076194-003LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2002-07-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076194-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2002-07-011e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076194-002LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2002-07-011e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076194-003LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2002-07-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076194-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / 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 UTC2026-02A076194-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076194-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076194-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076194-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076194-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076194-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076194-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076194-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076194-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076194-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076194-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076194-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076194-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076194-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076194-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076194-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076194-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076194-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076194-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076194-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076194-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076194-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076194-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076194-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076194-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076194-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076194-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076194-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076194-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076194-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076194-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076194-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076194-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076194-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076194-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076194-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076194-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076194-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076194-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076194-001AB18072bd15b7f6…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1108-0EA - Each50090-110805d113d1-c14b-449d-948c-a00a8c0e5ece12018-11-06
50090-1108-1EA - Each50090-110858310ff0-f0ce-459b-8cb2-d4e26bf6c0bf12018-11-06

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 1 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDENorthwind Health Company, LLC3d801e51-e675-45eb-bc7e-407e610f40092026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076194
application number: ANDA076194
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEQPharma Incff7b2d81-9006-465d-9095-1bd8696a12a62025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076194
application number: ANDA076194
Lisinopril and hydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDENuCarePharmaceuticals, Inc.4fbf31a1-037b-31a2-e054-00144ff88e882024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076194
application number: ANDA076194
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDENuCare Pharmaceuticals,Inc.6c57bf12-9ad5-3a25-e053-2a91aa0aaf262024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076194
application number: ANDA076194
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack2b66693d-0514-4f41-b405-bd3dd7618e812024-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076194
application number: ANDA076194
Lisinopril and hydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEProficient Rx LPaf0b3bef-be36-432a-884e-ea81e2d5c08e2022-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076194
application number: ANDA076194
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEActavis Pharma, Inc.ab5e9ae4-e575-4a63-99f3-2bde36bdd5082020-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076194
application number: ANDA076194
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEAphena Pharma Solutions - Tennessee, LLC5eea66bd-589a-45f8-ba2c-dea66a939d592019-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076194
application number: ANDA076194

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1108-05009011080030 TABLET in 1 BOTTLE (50090-1108-0) 30 tablet2014-11-280000-00-00NoNoCurrent