Home NDC 16571-799-01 Lisinopril
Product NDC 16571-799
Requested package NDC 16571-799-01
11-digit product format 165710799
Labeler code 16571
Product ID 16571-799_c031b428-c7d0-440a-90ab-d88ceef3c57c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lisinopril
Dosage form TABLET
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA077622
Marketing category ANDA
Marketing start 2006-02-22
Marketing end 0000-00-00
Substance LISINOPRIL
Active strength 40 mg/1
Pharmacologic classes Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]
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 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077622-001 LISINOPRIL LISINOPRIL 2.5MG TABLET / ORAL AB 2006-02-22 A077622-002 LISINOPRIL LISINOPRIL 5MG TABLET / ORAL AB 2006-02-22 A077622-003 LISINOPRIL LISINOPRIL 10MG TABLET / ORAL AB 2006-02-22 A077622-004 LISINOPRIL LISINOPRIL 20MG TABLET / ORAL AB 2006-02-22 A077622-005 LISINOPRIL LISINOPRIL 30MG TABLET / ORAL AB 2006-02-22 A077622-006 LISINOPRIL LISINOPRIL 40MG TABLET / ORAL AB 2006-02-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 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 7 · 258 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 A077622-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2006-02-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077622-002 LISINOPRIL 5MG TABLET / ORAL AB 2006-02-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077622-003 LISINOPRIL 10MG TABLET / ORAL AB 2006-02-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077622-004 LISINOPRIL 20MG TABLET / ORAL AB 2006-02-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077622-005 LISINOPRIL 30MG TABLET / ORAL AB 2006-02-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077622-006 LISINOPRIL 40MG TABLET / ORAL AB 2006-02-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077622-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2006-02-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077622-002 LISINOPRIL 5MG TABLET / ORAL AB 2006-02-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077622-003 LISINOPRIL 10MG TABLET / ORAL AB 2006-02-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077622-004 LISINOPRIL 20MG TABLET / ORAL AB 2006-02-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077622-005 LISINOPRIL 30MG TABLET / ORAL AB 2006-02-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077622-006 LISINOPRIL 40MG TABLET / ORAL AB 2006-02-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077622-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2006-02-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077622-002 LISINOPRIL 5MG TABLET / ORAL AB 2006-02-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077622-003 LISINOPRIL 10MG TABLET / ORAL AB 2006-02-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077622-004 LISINOPRIL 20MG TABLET / ORAL AB 2006-02-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077622-005 LISINOPRIL 30MG TABLET / ORAL AB 2006-02-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077622-006 LISINOPRIL 40MG TABLET / ORAL AB 2006-02-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077622-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2006-02-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077622-002 LISINOPRIL 5MG TABLET / ORAL AB 2006-02-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077622-003 LISINOPRIL 10MG TABLET / ORAL AB 2006-02-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077622-004 LISINOPRIL 20MG TABLET / ORAL AB 2006-02-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077622-005 LISINOPRIL 30MG TABLET / ORAL AB 2006-02-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077622-006 LISINOPRIL 40MG TABLET / ORAL AB 2006-02-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077622-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2006-02-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077622-002 LISINOPRIL 5MG TABLET / ORAL AB 2006-02-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077622-003 LISINOPRIL 10MG TABLET / ORAL AB 2006-02-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077622-004 LISINOPRIL 20MG TABLET / ORAL AB 2006-02-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077622-005 LISINOPRIL 30MG TABLET / ORAL AB 2006-02-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077622-006 LISINOPRIL 40MG TABLET / ORAL AB 2006-02-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077622-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2006-02-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077622-002 LISINOPRIL 5MG TABLET / ORAL AB 2006-02-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077622-003 LISINOPRIL 10MG TABLET / ORAL AB 2006-02-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077622-004 LISINOPRIL 20MG TABLET / ORAL AB 2006-02-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077622-005 LISINOPRIL 30MG TABLET / ORAL AB 2006-02-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077622-006 LISINOPRIL 40MG TABLET / ORAL AB 2006-02-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077622-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2006-02-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077622-002 LISINOPRIL 5MG TABLET / ORAL AB 2006-02-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077622-003 LISINOPRIL 10MG TABLET / ORAL AB 2006-02-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077622-004 LISINOPRIL 20MG TABLET / ORAL AB 2006-02-22 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 258 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lisinopril LISINOPRIL Aurobindo Pharma Limited 0e6364a4-6d66-4151-8197-d45e2a762895 2026-07-21 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077622 application number: ANDA077622
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 16571-799-01 16571079901 100 TABLET in 1 BOTTLE (16571-799-01) 100 tablet 2006-02-22 0000-00-00 No No Current