Home NDC 53217-253 Lisinopril
Product NDC 53217-253
11-digit product format 532170253
Labeler code 53217
Product ID 53217-253_069bd16d-3af5-4385-8843-f079cd0f6e85
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lisinopril
Dosage form TABLET
Route ORAL
Labeler Aidarex Pharmaceuticals LLC
Application ANDA076063
Marketing category ANDA
Marketing start 2013-02-13
Marketing end 0000-00-00
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 2019-12-31
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 2 · 105 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A076063-001 LISINOPRIL LISINOPRIL 2.5MG TABLET / ORAL 2002-07-01 A076063-002 LISINOPRIL LISINOPRIL 5MG TABLET / ORAL 2002-07-01 A076063-003 LISINOPRIL LISINOPRIL 10MG TABLET / ORAL 2002-07-01 A076063-004 LISINOPRIL LISINOPRIL 20MG TABLET / ORAL 2002-07-01 A076063-005 LISINOPRIL LISINOPRIL 40MG TABLET / ORAL 2002-07-01 A076063-006 LISINOPRIL LISINOPRIL 30MG TABLET / ORAL 2003-06-27
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 A076063-001 LISINOPRIL 2.5MG TABLET / ORAL 2002-07-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076063-002 LISINOPRIL 5MG TABLET / ORAL 2002-07-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076063-003 LISINOPRIL 10MG TABLET / ORAL 2002-07-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076063-004 LISINOPRIL 20MG TABLET / ORAL 2002-07-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076063-005 LISINOPRIL 40MG TABLET / ORAL 2002-07-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076063-006 LISINOPRIL 30MG TABLET / ORAL 2003-06-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076063-001 LISINOPRIL 2.5MG TABLET / ORAL 2002-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076063-002 LISINOPRIL 5MG TABLET / ORAL 2002-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076063-003 LISINOPRIL 10MG TABLET / ORAL 2002-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076063-004 LISINOPRIL 20MG TABLET / ORAL 2002-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076063-005 LISINOPRIL 40MG TABLET / ORAL 2002-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076063-006 LISINOPRIL 30MG TABLET / ORAL 2003-06-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076063-001 LISINOPRIL 2.5MG TABLET / ORAL 2002-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076063-002 LISINOPRIL 5MG TABLET / ORAL 2002-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076063-003 LISINOPRIL 10MG TABLET / ORAL 2002-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076063-004 LISINOPRIL 20MG TABLET / ORAL 2002-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076063-005 LISINOPRIL 40MG TABLET / ORAL 2002-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076063-006 LISINOPRIL 30MG TABLET / ORAL 2003-06-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076063-001 LISINOPRIL 2.5MG TABLET / ORAL 2002-07-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076063-002 LISINOPRIL 5MG TABLET / ORAL 2002-07-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076063-003 LISINOPRIL 10MG TABLET / ORAL 2002-07-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076063-004 LISINOPRIL 20MG TABLET / ORAL 2002-07-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076063-005 LISINOPRIL 40MG TABLET / ORAL 2002-07-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076063-006 LISINOPRIL 30MG TABLET / ORAL 2003-06-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076063-001 LISINOPRIL 2.5MG TABLET / ORAL 2002-07-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076063-002 LISINOPRIL 5MG TABLET / ORAL 2002-07-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076063-003 LISINOPRIL 10MG TABLET / ORAL 2002-07-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076063-004 LISINOPRIL 20MG TABLET / ORAL 2002-07-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076063-005 LISINOPRIL 40MG TABLET / ORAL 2002-07-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076063-006 LISINOPRIL 30MG TABLET / ORAL 2003-06-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076063-001 LISINOPRIL 2.5MG TABLET / ORAL 2002-07-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076063-002 LISINOPRIL 5MG TABLET / ORAL 2002-07-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076063-003 LISINOPRIL 10MG TABLET / ORAL 2002-07-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076063-004 LISINOPRIL 20MG TABLET / ORAL 2002-07-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076063-005 LISINOPRIL 40MG TABLET / ORAL 2002-07-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076063-006 LISINOPRIL 30MG TABLET / ORAL 2003-06-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076063-001 LISINOPRIL 2.5MG TABLET / ORAL 2002-07-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076063-002 LISINOPRIL 5MG TABLET / ORAL 2002-07-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076063-003 LISINOPRIL 10MG TABLET / ORAL 2002-07-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076063-004 LISINOPRIL 20MG TABLET / ORAL 2002-07-01 03ed91905a0d…
Observed Orange Book normalized TE history# DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Related label table NDC Related label 53217-253-02 These highlights do not include all the information needed to use LISINOPRIL TABLETS, USP safely and effectively. See full prescribing information for LISINOPRIL TABLETS, USP . LISINOPRIL tablets , for oral use Initial U.S. Approval: 1988 53217-253-30 These highlights do not include all the information needed to use LISINOPRIL TABLETS, USP safely and effectively. See full prescribing information for LISINOPRIL TABLETS, USP . LISINOPRIL tablets , for oral use Initial U.S. Approval: 1988 53217-253-60 These highlights do not include all the information needed to use LISINOPRIL TABLETS, USP safely and effectively. See full prescribing information for LISINOPRIL TABLETS, USP . LISINOPRIL tablets , for oral use Initial U.S. Approval: 1988 53217-253-90 These highlights do not include all the information needed to use LISINOPRIL TABLETS, USP safely and effectively. See full prescribing information for LISINOPRIL TABLETS, USP . LISINOPRIL tablets , for oral use Initial U.S. Approval: 1988
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53217-253-02 Lisinopril 120 in 1 BOTTLE TABLET 120 1 53217-253-30 Lisinopril 30 in 1 BOTTLE TABLET 30 1 53217-253-60 Lisinopril 60 in 1 BOTTLE TABLET 60 1 53217-253-90 Lisinopril 90 in 1 BOTTLE TABLET 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53217-253 LISINOPRIL TABLET [AIDAREX PHARMACEUTICALS LLC] 1 Legacy NDC, 4 package rows 20161111_bb6ec726-a143-4811-be3c-1a404459dee6.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 53217-253-02 53217025302 120 in 1 BOTTLE Historical 53217-253-30 53217025330 30 in 1 BOTTLE Historical 53217-253-60 53217025360 60 in 1 BOTTLE Historical 53217-253-90 53217025390 90 in 1 BOTTLE Historical