Home NDC 51407-566 LISINOPRIL and HYDROCHLOROTHIAZIDE
Product NDC 51407-566
11-digit product format 514070566
Labeler code 51407
Product ID 51407-566_fd91c3d4-99e0-4b5d-8f6c-d08f19b64703
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LISINOPRIL and HYDROCHLOROTHIAZIDE
Dosage form TABLET
Route ORAL
Labeler GSMS, Incorporated
Application ANDA076674
Marketing category ANDA
Marketing start 2025-02-15
Substance LISINOPRIL; HYDROCHLOROTHIAZIDE
Active strength 20; 25 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 44 .
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 A076674-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;10MG TABLET / ORAL AB 2004-10-05 A076674-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;20MG TABLET / ORAL AB 2004-10-05 A076674-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 25MG;20MG TABLET / ORAL AB 2004-10-05
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 · 132 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 2026-10-15 13:18:30 2026-09 A076674-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL AB 2004-10-05 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076674-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2004-10-05 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076674-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL AB 2004-10-05 c2088c7a36db…2026-09-14 22:38:34 2026-08 A076674-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL AB 2004-10-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076674-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2004-10-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076674-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL AB 2004-10-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076674-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL AB 2004-10-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076674-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2004-10-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076674-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL AB 2004-10-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076674-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL AB 2004-10-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076674-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2004-10-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076674-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL AB 2004-10-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076674-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL AB 2004-10-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076674-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2004-10-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076674-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL AB 2004-10-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076674-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL AB 2004-10-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076674-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2004-10-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076674-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL AB 2004-10-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076674-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL AB 2004-10-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076674-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2004-10-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076674-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL AB 2004-10-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076674-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL AB 2004-10-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076674-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2004-10-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076674-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL AB 2004-10-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076674-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL AB 2004-10-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076674-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2004-10-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076674-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL AB 2004-10-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076674-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL AB 2004-10-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076674-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2004-10-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076674-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL AB 2004-10-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076674-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL 2004-10-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076674-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL 2004-10-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076674-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL 2004-10-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076674-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL AB 2004-10-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076674-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2004-10-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076674-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL AB 2004-10-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076674-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL AB 2004-10-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076674-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2004-10-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076674-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL AB 2004-10-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076674-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL 2004-10-05 79d66fd596c7…
Observed Orange Book normalized TE history# 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 Ingredient Strength LISINOPRIL 20 mg/1 HYDROCHLOROTHIAZIDE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0J48LPH2TH Internal UNII lookup E7199S1YWR Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197885 Internal RxNorm lookup 197886 Internal RxNorm lookup 197887 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51407-566-05 LISINOPRIL and HYDROCHLOROTHIAZIDE 500 in 1 BOTTLE TABLET 500 1 51407-566-90 LISINOPRIL and HYDROCHLOROTHIAZIDE 90 in 1 BOTTLE TABLET 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51407-566 LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [GSMS, INCORPORATED] 1 Current NDC, 2 package rows 20250226_d02a0d38-676a-4e0f-9aa2-0a6c56cd7361.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 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51407-566-05 51407056605 500 TABLET in 1 BOTTLE (51407-566-05) 500 tablet 2025-02-15 No No Current 51407-566-90 51407056690 90 TABLET in 1 BOTTLE (51407-566-90) 90 tablet 2025-02-15 No No Current