Home NDC 82804-307 Lisinopril and Hydrochlorothiazide
Product NDC 82804-307
11-digit product format 828040307
Labeler code 82804
Product ID 82804-307_5ee68045-a180-4d19-8d03-93074dbf7cd6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lisinopril and Hydrochlorothiazide Tablets
Dosage form TABLET
Route ORAL
Labeler Proficient Rx LP
Application ANDA076230
Marketing category ANDA
Marketing start 2015-03-12
Substance LISINOPRIL; HYDROCHLOROTHIAZIDE
Active strength 10; 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 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 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 · 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 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…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076230-002 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2002-07-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076230-003 LISINOPRIL AND HYDROCHLOROTHIAZIDE 25MG;20MG TABLET / ORAL AB 2002-07-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076230-001 LISINOPRIL AND HYDROCHLOROTHIAZIDE 12.5MG;10MG TABLET / ORAL AB 2002-07-01 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.
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 10 mg/1 HYDROCHLOROTHIAZIDE 12.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination E7199S1YWR Internal UNII lookup 0J48LPH2TH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197885 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 · 22 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 82804-307-30 82804030730 30 TABLET in 1 BOTTLE (82804-307-30) 30 tablet 2026-08-26 No No Current 82804-307-90 82804030790 90 TABLET in 1 BOTTLE (82804-307-90) 90 tablet 2026-07-24 No No Current