Home NDC 16729-375 LISINOPRIL
Product NDC 16729-375
11-digit product format 167290375
Labeler code 16729
Product ID 16729-375_ecb64f83-e355-31a4-e053-2a95a90a4071
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lisinopril
Dosage form TABLET
Route ORAL
Labeler Accord Healthcare Inc.
Application ANDA202554
Marketing category ANDA
Marketing start 2016-12-22
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 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 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A202554-001 LISINOPRIL LISINOPRIL 2.5MG TABLET / ORAL 2013-07-30 A202554-002 LISINOPRIL LISINOPRIL 5MG TABLET / ORAL 2013-07-30 A202554-003 LISINOPRIL LISINOPRIL 10MG TABLET / ORAL 2013-07-30 A202554-004 LISINOPRIL LISINOPRIL 20MG TABLET / ORAL 2013-07-30 A202554-005 LISINOPRIL LISINOPRIL 30MG TABLET / ORAL 2013-07-30 A202554-006 LISINOPRIL LISINOPRIL 40MG TABLET / ORAL 2013-07-30
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 · 264 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 A202554-001 LISINOPRIL 2.5MG TABLET / ORAL 2013-07-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A202554-002 LISINOPRIL 5MG TABLET / ORAL 2013-07-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A202554-003 LISINOPRIL 10MG TABLET / ORAL 2013-07-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A202554-004 LISINOPRIL 20MG TABLET / ORAL 2013-07-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A202554-005 LISINOPRIL 30MG TABLET / ORAL 2013-07-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A202554-006 LISINOPRIL 40MG TABLET / ORAL 2013-07-30 c2088c7a36db…2026-09-14 22:38:34 2026-08 A202554-001 LISINOPRIL 2.5MG TABLET / ORAL 2013-07-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202554-002 LISINOPRIL 5MG TABLET / ORAL 2013-07-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202554-003 LISINOPRIL 10MG TABLET / ORAL 2013-07-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202554-004 LISINOPRIL 20MG TABLET / ORAL 2013-07-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202554-005 LISINOPRIL 30MG TABLET / ORAL 2013-07-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202554-006 LISINOPRIL 40MG TABLET / ORAL 2013-07-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202554-001 LISINOPRIL 2.5MG TABLET / ORAL 2013-07-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202554-002 LISINOPRIL 5MG TABLET / ORAL 2013-07-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202554-003 LISINOPRIL 10MG TABLET / ORAL 2013-07-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202554-004 LISINOPRIL 20MG TABLET / ORAL 2013-07-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202554-005 LISINOPRIL 30MG TABLET / ORAL 2013-07-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202554-006 LISINOPRIL 40MG TABLET / ORAL 2013-07-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202554-001 LISINOPRIL 2.5MG TABLET / ORAL 2013-07-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202554-002 LISINOPRIL 5MG TABLET / ORAL 2013-07-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202554-003 LISINOPRIL 10MG TABLET / ORAL 2013-07-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202554-004 LISINOPRIL 20MG TABLET / ORAL 2013-07-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202554-005 LISINOPRIL 30MG TABLET / ORAL 2013-07-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202554-006 LISINOPRIL 40MG TABLET / ORAL 2013-07-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202554-001 LISINOPRIL 2.5MG TABLET / ORAL 2013-07-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202554-002 LISINOPRIL 5MG TABLET / ORAL 2013-07-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202554-003 LISINOPRIL 10MG TABLET / ORAL 2013-07-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202554-004 LISINOPRIL 20MG TABLET / ORAL 2013-07-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202554-005 LISINOPRIL 30MG TABLET / ORAL 2013-07-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202554-006 LISINOPRIL 40MG TABLET / ORAL 2013-07-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202554-001 LISINOPRIL 2.5MG TABLET / ORAL 2013-07-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202554-002 LISINOPRIL 5MG TABLET / ORAL 2013-07-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202554-003 LISINOPRIL 10MG TABLET / ORAL 2013-07-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202554-004 LISINOPRIL 20MG TABLET / ORAL 2013-07-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202554-005 LISINOPRIL 30MG TABLET / ORAL 2013-07-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202554-006 LISINOPRIL 40MG TABLET / ORAL 2013-07-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202554-001 LISINOPRIL 2.5MG TABLET / ORAL 2013-07-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202554-002 LISINOPRIL 5MG TABLET / ORAL 2013-07-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202554-003 LISINOPRIL 10MG TABLET / ORAL 2013-07-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202554-004 LISINOPRIL 20MG TABLET / ORAL 2013-07-30 fd3edfee7708…
Observed Orange Book normalized TE history# Normalized TE history page 5 of 5 · 162 observed states.
Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A202554-005 AB 1 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A202554-006 AB 1 cb3db0bc1861…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 16729-375-01 16729037501 100 TABLET in 1 BOTTLE (16729-375-01) 100 tablet 2018-10-17 0000-00-00 No No Current 16729-375-16 16729037516 500 TABLET in 1 BOTTLE (16729-375-16) 500 tablet 2018-10-17 0000-00-00 No No Current 16729-375-17 16729037517 1000 TABLET in 1 BOTTLE (16729-375-17) 1000 tablet 2018-10-17 0000-00-00 No No Current