Home NDC 43353-301 lisinopril
Product NDC 43353-301
11-digit product format 433530301
Labeler code 43353
Product ID 43353-301_c7e48d97-db9a-465d-938b-215db53d3f58
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lisinopril
Dosage form TABLET
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA203508
Marketing category ANDA
Marketing start 2014-03-15
Substance LISINOPRIL
Active strength 10 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 A203508-001 LISINOPRIL LISINOPRIL 2.5MG TABLET / ORAL AB 2013-10-29 A203508-002 LISINOPRIL LISINOPRIL 5MG TABLET / ORAL AB 2013-10-29 A203508-003 LISINOPRIL LISINOPRIL 10MG TABLET / ORAL AB 2013-10-29 A203508-004 LISINOPRIL LISINOPRIL 20MG TABLET / ORAL AB 2013-10-29 A203508-005 LISINOPRIL LISINOPRIL 30MG TABLET / ORAL AB 2013-10-29 A203508-006 LISINOPRIL LISINOPRIL 40MG TABLET / ORAL AB 2013-10-29
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 A203508-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2013-10-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203508-002 LISINOPRIL 5MG TABLET / ORAL AB 2013-10-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203508-003 LISINOPRIL 10MG TABLET / ORAL AB 2013-10-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203508-004 LISINOPRIL 20MG TABLET / ORAL AB 2013-10-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203508-005 LISINOPRIL 30MG TABLET / ORAL AB 2013-10-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203508-006 LISINOPRIL 40MG TABLET / ORAL AB 2013-10-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203508-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2013-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203508-002 LISINOPRIL 5MG TABLET / ORAL AB 2013-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203508-003 LISINOPRIL 10MG TABLET / ORAL AB 2013-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203508-004 LISINOPRIL 20MG TABLET / ORAL AB 2013-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203508-005 LISINOPRIL 30MG TABLET / ORAL AB 2013-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203508-006 LISINOPRIL 40MG TABLET / ORAL AB 2013-10-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203508-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2013-10-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203508-002 LISINOPRIL 5MG TABLET / ORAL AB 2013-10-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203508-003 LISINOPRIL 10MG TABLET / ORAL AB 2013-10-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203508-004 LISINOPRIL 20MG TABLET / ORAL AB 2013-10-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203508-005 LISINOPRIL 30MG TABLET / ORAL AB 2013-10-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203508-006 LISINOPRIL 40MG TABLET / ORAL AB 2013-10-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203508-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2013-10-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203508-002 LISINOPRIL 5MG TABLET / ORAL AB 2013-10-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203508-003 LISINOPRIL 10MG TABLET / ORAL AB 2013-10-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203508-004 LISINOPRIL 20MG TABLET / ORAL AB 2013-10-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203508-005 LISINOPRIL 30MG TABLET / ORAL AB 2013-10-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203508-006 LISINOPRIL 40MG TABLET / ORAL AB 2013-10-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203508-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2013-10-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203508-002 LISINOPRIL 5MG TABLET / ORAL AB 2013-10-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203508-003 LISINOPRIL 10MG TABLET / ORAL AB 2013-10-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203508-004 LISINOPRIL 20MG TABLET / ORAL AB 2013-10-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203508-005 LISINOPRIL 30MG TABLET / ORAL AB 2013-10-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203508-006 LISINOPRIL 40MG TABLET / ORAL AB 2013-10-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203508-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2013-10-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203508-002 LISINOPRIL 5MG TABLET / ORAL AB 2013-10-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203508-003 LISINOPRIL 10MG TABLET / ORAL AB 2013-10-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203508-004 LISINOPRIL 20MG TABLET / ORAL AB 2013-10-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203508-005 LISINOPRIL 30MG TABLET / ORAL AB 2013-10-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203508-006 LISINOPRIL 40MG TABLET / ORAL AB 2013-10-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203508-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2013-10-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203508-002 LISINOPRIL 5MG TABLET / ORAL AB 2013-10-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203508-003 LISINOPRIL 10MG TABLET / ORAL AB 2013-10-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203508-004 LISINOPRIL 20MG TABLET / ORAL AB 2013-10-29 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 10 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 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197884 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 43353-301-30 lisinopril 30 in 1 BOTTLE TABLET 30 4 43353-301-45 lisinopril 45 in 1 BOTTLE TABLET 45 4 43353-301-60 lisinopril 90 in 1 BOTTLE TABLET 90 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-301 LISINOPRIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 4 Current NDC, Legacy NDC, 3 package rows 20210811_32eb18bc-a80d-4de1-8f38-e591d8f66870.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 · 2 matching rows.
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 43353-301-30 43353030130 30 TABLET in 1 BOTTLE (43353-301-30) 30 tablet 2017-04-04 0000-00-00 No No Current 43353-301-45 43353030145 45 TABLET in 1 BOTTLE (43353-301-45) 45 tablet 2021-03-09 0000-00-00 No No Current 43353-301-60 43353030160 90 TABLET in 1 BOTTLE (43353-301-60) 90 tablet 2021-02-12 0000-00-00 No No Current