Home NDC 68645-609 Lisinopril
Product NDC 68645-609
11-digit product format 686450609
Labeler code 68645
Product ID 68645-609_4c4a3bfb-4ac1-2112-e063-6394a90ac32f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lisinopril
Dosage form TABLET
Route ORAL
Labeler Legacy Pharmaceutical Packaging, LLC
Application ANDA075903
Marketing category ANDA
Marketing start 2021-08-17
Substance LISINOPRIL
Active strength 5 mg/1
Pharmacologic classes Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]
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 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075903-001 LISINOPRIL LISINOPRIL 2.5MG TABLET / ORAL AB 2002-07-01 A075903-002 LISINOPRIL LISINOPRIL 5MG TABLET / ORAL AB 2002-07-01 A075903-003 LISINOPRIL LISINOPRIL 10MG TABLET / ORAL AB 2002-07-01 A075903-004 LISINOPRIL LISINOPRIL 20MG TABLET / ORAL AB 2002-07-01 A075903-005 LISINOPRIL LISINOPRIL 30MG TABLET / ORAL AB 2002-07-01 A075903-006 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 · 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 A075903-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2002-07-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075903-002 LISINOPRIL 5MG TABLET / ORAL AB 2002-07-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075903-003 LISINOPRIL 10MG TABLET / ORAL AB 2002-07-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075903-004 LISINOPRIL 20MG TABLET / ORAL AB 2002-07-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075903-005 LISINOPRIL 30MG TABLET / ORAL AB 2002-07-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075903-006 LISINOPRIL 40MG TABLET / ORAL AB 2002-07-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075903-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2002-07-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075903-002 LISINOPRIL 5MG TABLET / ORAL AB 2002-07-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075903-003 LISINOPRIL 10MG TABLET / ORAL AB 2002-07-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075903-004 LISINOPRIL 20MG TABLET / ORAL AB 2002-07-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075903-005 LISINOPRIL 30MG TABLET / ORAL AB 2002-07-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075903-006 LISINOPRIL 40MG TABLET / ORAL AB 2002-07-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075903-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2002-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075903-002 LISINOPRIL 5MG TABLET / ORAL AB 2002-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075903-003 LISINOPRIL 10MG TABLET / ORAL AB 2002-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075903-004 LISINOPRIL 20MG TABLET / ORAL AB 2002-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075903-005 LISINOPRIL 30MG TABLET / ORAL AB 2002-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075903-006 LISINOPRIL 40MG TABLET / ORAL AB 2002-07-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075903-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2002-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075903-002 LISINOPRIL 5MG TABLET / ORAL AB 2002-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075903-003 LISINOPRIL 10MG TABLET / ORAL AB 2002-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075903-004 LISINOPRIL 20MG TABLET / ORAL AB 2002-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075903-005 LISINOPRIL 30MG TABLET / ORAL AB 2002-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075903-006 LISINOPRIL 40MG TABLET / ORAL AB 2002-07-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075903-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2002-07-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075903-002 LISINOPRIL 5MG TABLET / ORAL AB 2002-07-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075903-003 LISINOPRIL 10MG TABLET / ORAL AB 2002-07-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075903-004 LISINOPRIL 20MG TABLET / ORAL AB 2002-07-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075903-005 LISINOPRIL 30MG TABLET / ORAL AB 2002-07-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075903-006 LISINOPRIL 40MG TABLET / ORAL AB 2002-07-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075903-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2002-07-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075903-002 LISINOPRIL 5MG TABLET / ORAL AB 2002-07-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075903-003 LISINOPRIL 10MG TABLET / ORAL AB 2002-07-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075903-004 LISINOPRIL 20MG TABLET / ORAL AB 2002-07-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075903-005 LISINOPRIL 30MG TABLET / ORAL AB 2002-07-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075903-006 LISINOPRIL 40MG TABLET / ORAL AB 2002-07-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075903-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2002-07-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075903-002 LISINOPRIL 5MG TABLET / ORAL AB 2002-07-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075903-003 LISINOPRIL 10MG TABLET / ORAL AB 2002-07-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075903-004 LISINOPRIL 20MG TABLET / ORAL AB 2002-07-01 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 210 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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LISINOPRIL 5 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# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68645-609-90 Lisinopril 90 in 1 BOTTLE TABLET 90 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68645-609 LISINOPRIL TABLET [LEGACY PHARMACEUTICAL PACKAGING, LLC] 5 Current NDC, 1 package rows 20250418_f5db9549-e179-3db6-e053-2995a90a1544.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 Legacy Pharmaceutical Packaging, LLC f5db9549-e179-3db6-e053-2995a90a1544 2026-03-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075903 application number: ANDA075903 ndc (product): 68645-609 Lisinopril LISINOPRIL Camber Pharmaceuticals, Inc. 387068e7-7fb9-44f3-ae1c-e45ebc755a3e 2024-08-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075903 application number: ANDA075903 Lisinopril LISINOPRIL Camber Pharmaceuticals, Inc. 8f20acd7-2635-4a9b-b732-2a84ea93dea7 2021-11-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075903 application number: ANDA075903 Lisinopril LISINOPRIL XLCare Pharmaceuticals Inc. c008ecb6-970d-4ac9-9402-e21e8d9d76b2 2021-09-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075903 application number: ANDA075903
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68645-609-90 68645060990 90 TABLET in 1 BOTTLE (68645-609-90) 90 tablet 2023-03-01 No No Current