Home NDC 43547-417 Lisinopril
Product NDC 43547-417
11-digit product format 435470417
Labeler code 43547
Product ID 43547-417_1ed80b02-cb3b-41c5-ab33-ff0106b8792d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lisinopril
Dosage form TABLET
Route ORAL
Labeler Solco healthcare U.S., LLC
Application ANDA075743
Marketing category ANDA
Marketing start 2017-08-30
Substance LISINOPRIL
Active strength 20 mg/1
Pharmacologic classes Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A075743-001 LISINOPRIL LISINOPRIL 2.5MG TABLET / ORAL AB 2002-07-01 A075743-002 LISINOPRIL LISINOPRIL 5MG TABLET / ORAL AB 2002-07-01 A075743-003 LISINOPRIL LISINOPRIL 10MG TABLET / ORAL AB 2002-07-01 A075743-004 LISINOPRIL LISINOPRIL 20MG TABLET / ORAL AB 2002-07-01 A075743-005 LISINOPRIL LISINOPRIL 30MG TABLET / ORAL AB 2002-07-01 A075743-006 LISINOPRIL LISINOPRIL 40MG TABLET / ORAL AB 2002-07-01
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 · 252 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 2026-08-18 06:07:40 2026-07 A075743-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2002-07-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075743-002 LISINOPRIL 5MG TABLET / ORAL AB 2002-07-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075743-003 LISINOPRIL 10MG TABLET / ORAL AB 2002-07-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075743-004 LISINOPRIL 20MG TABLET / ORAL AB 2002-07-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075743-005 LISINOPRIL 30MG TABLET / ORAL AB 2002-07-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075743-006 LISINOPRIL 40MG TABLET / ORAL AB 2002-07-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075743-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2002-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075743-002 LISINOPRIL 5MG TABLET / ORAL AB 2002-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075743-003 LISINOPRIL 10MG TABLET / ORAL AB 2002-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075743-004 LISINOPRIL 20MG TABLET / ORAL AB 2002-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075743-005 LISINOPRIL 30MG TABLET / ORAL AB 2002-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075743-006 LISINOPRIL 40MG TABLET / ORAL AB 2002-07-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075743-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2002-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075743-002 LISINOPRIL 5MG TABLET / ORAL AB 2002-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075743-003 LISINOPRIL 10MG TABLET / ORAL AB 2002-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075743-004 LISINOPRIL 20MG TABLET / ORAL AB 2002-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075743-005 LISINOPRIL 30MG TABLET / ORAL AB 2002-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075743-006 LISINOPRIL 40MG TABLET / ORAL AB 2002-07-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075743-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2002-07-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075743-002 LISINOPRIL 5MG TABLET / ORAL AB 2002-07-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075743-003 LISINOPRIL 10MG TABLET / ORAL AB 2002-07-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075743-004 LISINOPRIL 20MG TABLET / ORAL AB 2002-07-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075743-005 LISINOPRIL 30MG TABLET / ORAL AB 2002-07-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075743-006 LISINOPRIL 40MG TABLET / ORAL AB 2002-07-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075743-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2002-07-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075743-002 LISINOPRIL 5MG TABLET / ORAL AB 2002-07-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075743-003 LISINOPRIL 10MG TABLET / ORAL AB 2002-07-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075743-004 LISINOPRIL 20MG TABLET / ORAL AB 2002-07-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075743-005 LISINOPRIL 30MG TABLET / ORAL AB 2002-07-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075743-006 LISINOPRIL 40MG TABLET / ORAL AB 2002-07-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075743-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2002-07-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075743-002 LISINOPRIL 5MG TABLET / ORAL AB 2002-07-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075743-003 LISINOPRIL 10MG TABLET / ORAL AB 2002-07-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075743-004 LISINOPRIL 20MG TABLET / ORAL AB 2002-07-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075743-005 LISINOPRIL 30MG TABLET / ORAL AB 2002-07-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075743-006 LISINOPRIL 40MG TABLET / ORAL AB 2002-07-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075743-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2002-07-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075743-002 LISINOPRIL 5MG TABLET / ORAL AB 2002-07-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075743-003 LISINOPRIL 10MG TABLET / ORAL AB 2002-07-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075743-004 LISINOPRIL 20MG TABLET / ORAL AB 2002-07-01 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 252 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Lisinopril
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LISINOPRIL 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination E7199S1YWR Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197884 Internal RxNorm lookup 205326 Internal RxNorm lookup 311353 Internal RxNorm lookup 311354 Internal RxNorm lookup 314076 Internal RxNorm lookup 314077 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43547-417 LISINOPRIL TABLET [SOLCO HEALTHCARE U.S., LLC] 5 Current NDC, Legacy NDC, 6 package rows 20221118_f8d16c85-50e2-4d99-afae-6fb902734e42.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 1 of 1 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lisinopril LISINOPRIL PD-Rx Pharmaceuticals, Inc. b62815f3-77fc-4074-a28a-918ab5cc32db 2025-10-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075743 application number: ANDA075743 Lisinopril LISINOPRIL Aphena Pharma Solutions - Tennessee, LLC a79a034d-7bbb-4b05-b8fc-8ebf09f33c0c 2023-10-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075743 application number: ANDA075743 Lisinopril LISINOPRIL Solco healthcare U.S., LLC f8d16c85-50e2-4d99-afae-6fb902734e42 2022-06-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075743 application number: ANDA075743 ndc (product): 43547-417 Lisinopril LISINOPRIL Aphena Pharma Solutions - Tennessee, LLC 1c0250c7-ff57-411b-852b-b8e4573f2057 2020-04-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075743 application number: ANDA075743
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 43547-417-04 43547041704 45 TABLET in 1 BOTTLE (43547-417-04) 45 tablet 2017-08-30 0000-00-00 No No Current 43547-417-09 43547041709 90 TABLET in 1 BOTTLE (43547-417-09) 90 tablet 2017-08-30 0000-00-00 No No Current 43547-417-10 43547041710 100 TABLET in 1 BOTTLE (43547-417-10) 100 tablet 2017-08-30 0000-00-00 No No Current 43547-417-11 43547041711 1000 TABLET in 1 BOTTLE (43547-417-11) 1000 tablet 2017-08-30 0000-00-00 No No Current 43547-417-15 43547041715 5000 TABLET in 1 BOTTLE (43547-417-15) 5000 tablet 2017-08-30 0000-00-00 No No Current 43547-417-50 43547041750 500 TABLET in 1 BOTTLE (43547-417-50) 500 tablet 2017-08-30 0000-00-00 No No Current