Home NDC 70518-3505 Lisinopril and Hydrochlorothiazide
Product NDC 70518-3505
11-digit product format 705183505
Labeler code 70518
Product ID 70518-3505_5da3e18e-3aba-1aa6-e063-6394a90a3468
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lisinopril and Hydrochlorothiazide Tablets
Dosage form TABLET
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA076230
Marketing category ANDA
Marketing start 2022-08-31
Substance LISINOPRIL; HYDROCHLOROTHIAZIDE
Active strength 20; 12.5 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 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 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70518-3505 70518-3505-2 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70518-3505 70518-3505-3 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 70518-3505 70518-3505-2 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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 A076230-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;10MG TABLET / ORAL AB 2002-07-01 A076230-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;20MG TABLET / ORAL AB 2002-07-01 A076230-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 25MG;20MG TABLET / ORAL AB 2002-07-01
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 A076230-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL AB 2002-07-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076230-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2002-07-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076230-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL AB 2002-07-01 c2088c7a36db…2026-09-14 22:38:34 2026-08 A076230-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL AB 2002-07-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076230-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2002-07-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076230-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL AB 2002-07-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076230-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL AB 2002-07-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076230-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2002-07-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076230-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL AB 2002-07-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076230-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL AB 2002-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076230-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2002-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076230-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL AB 2002-07-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076230-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL AB 2002-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076230-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2002-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076230-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL AB 2002-07-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076230-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL AB 2002-07-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076230-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2002-07-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076230-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL AB 2002-07-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076230-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL AB 2002-07-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076230-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2002-07-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076230-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL AB 2002-07-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076230-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL AB 2002-07-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076230-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2002-07-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076230-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL AB 2002-07-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076230-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL AB 2002-07-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076230-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2002-07-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076230-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL AB 2002-07-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076230-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL AB 2002-07-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076230-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2002-07-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076230-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL AB 2002-07-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076230-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL AB 2002-07-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076230-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2002-07-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076230-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL AB 2002-07-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076230-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL AB 2002-07-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076230-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2002-07-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076230-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL AB 2002-07-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076230-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL AB 2002-07-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076230-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2002-07-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076230-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL AB 2002-07-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076230-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL AB 2002-07-01 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 observed states.
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 12.5 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70518-3505-0 Lisinopril and Hydrochlorothiazide 90 in 1 BOTTLE, PLASTIC TABLET 90 10 70518-3505-1 Lisinopril and Hydrochlorothiazide 30 in 1 BLISTER PACK TABLET 30 10 70518-3505-2 Lisinopril and Hydrochlorothiazide 30 in 1 BOTTLE, PLASTIC TABLET 30 10 70518-3505-3 Lisinopril and Hydrochlorothiazide 90 in 1 BOTTLE, PLASTIC TABLET 90 10 70518-3505-4 Lisinopril and Hydrochlorothiazide 100 in 1 BOTTLE, PLASTIC TABLET 100 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-3505 LISINOPRIL AND HYDROCHLOROTHIAZIDE (LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS) TABLET [REMEDYREPACK INC.] 6 Current NDC, Legacy NDC, 5 package rows 20250322_3bea11a3-eb07-46b2-9b91-f8a48a2f3b7e.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 2 of 2 · 21 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70518-3505-0 70518350500 90 TABLET in 1 BOTTLE, PLASTIC (70518-3505-0) 90 tablet 2022-08-31 0000-00-00 No No Current 70518-3505-1 70518350501 30 TABLET in 1 BLISTER PACK (70518-3505-1) 30 tablet 2022-09-22 0000-00-00 No No Current 70518-3505-2 70518350502 30 TABLET in 1 BOTTLE, PLASTIC (70518-3505-2) 30 tablet 2022-11-01 0000-00-00 No No Current 70518-3505-3 70518350503 90 in 1 BOTTLE, PLASTIC Historical 70518-3505-4 70518350504 100 TABLET in 1 BOTTLE, PLASTIC (70518-3505-4) 100 tablet 2025-03-20 No No Current