Home NDC 16571-792-50 Lisinopril and Hydrochlorothiazide
Product NDC 16571-792
Requested package NDC 16571-792-50
11-digit product format 165710792
Labeler code 16571
Product ID 16571-792_2f19b802-e931-471f-83f3-e116a84b1bb8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lisinopril and Hydrochlorothiazide
Dosage form TABLET
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA077606
Marketing category ANDA
Marketing start 2006-03-14
Marketing end 0000-00-00
Substance HYDROCHLOROTHIAZIDE; LISINOPRIL
Active strength 13 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 2023-12-31
Current FDA listing Historical FDA.report record 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 date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077606-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;10MG TABLET / ORAL AB 2006-03-14 A077606-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;20MG TABLET / ORAL AB 2006-03-14 A077606-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 25MG;20MG TABLET / ORAL AB 2006-03-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A077606-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL AB 2006-03-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077606-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2006-03-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077606-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL AB 2006-03-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077606-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL AB 2006-03-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077606-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2006-03-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077606-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL AB 2006-03-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077606-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL AB 2006-03-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077606-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2006-03-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077606-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL AB 2006-03-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077606-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL AB 2006-03-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077606-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2006-03-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077606-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL AB 2006-03-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077606-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL AB 2006-03-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077606-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2006-03-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077606-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL AB 2006-03-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077606-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL AB 2006-03-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077606-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2006-03-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077606-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL AB 2006-03-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077606-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL AB 2006-03-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077606-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2006-03-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077606-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL AB 2006-03-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077606-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL AB 2006-03-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077606-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2006-03-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077606-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL AB 2006-03-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077606-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL AB 2006-03-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077606-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2006-03-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077606-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL AB 2006-03-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077606-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL AB 2006-03-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077606-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2006-03-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077606-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL AB 2006-03-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077606-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL AB 2006-03-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077606-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2006-03-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077606-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL AB 2006-03-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077606-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL AB 2006-03-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077606-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2006-03-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077606-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL AB 2006-03-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077606-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL AB 2006-03-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077606-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2006-03-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077606-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL AB 2006-03-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077606-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL AB 2006-03-14 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 16571-792-50 16571079250 500 TABLET in 1 BOTTLE (16571-792-50) 500 tablet 2006-03-14 0000-00-00 No No Current