Home NDC 57237-052 Lisinopril
Product NDC 57237-052
11-digit product format 572370052
Labeler code 57237
Product ID 57237-052_dc0a5a29-63b0-44f6-ad5b-e39e7634b5b4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lisinopril
Dosage form TABLET
Route ORAL
Labeler Citron Pharma LLC
Application ANDA077622
Marketing category ANDA
Marketing start 2006-02-22
Marketing end 0000-00-00
Substance LISINOPRIL
Active strength 3 mg/1
Pharmacologic classes Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag E
Listing certified through 2018-12-31
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 7 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