Home NDC 69117-0038-5 Lisinopril
Product NDC 69117-0038
Requested package NDC 69117-0038-5
11-digit product format 691170038
Labeler code 69117
Product ID 69117-0038_d62739e8-a663-5771-e053-2995a90a066a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lisinopril
Dosage form TABLET
Route ORAL
Labeler Yiling Pharmaceutical, Inc.
Application ANDA212041
Marketing category ANDA
Marketing start 2020-09-15
Marketing end 0000-00-00
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 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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212041-001 LISINOPRIL LISINOPRIL 2.5MG TABLET / ORAL AB 2020-09-15 A212041-002 LISINOPRIL LISINOPRIL 5MG TABLET / ORAL AB 2020-09-15 A212041-003 LISINOPRIL LISINOPRIL 10MG TABLET / ORAL AB 2020-09-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 3 · 111 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 2026-02-19 14:30 UTC 2026-02 A212041-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2020-09-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212041-002 LISINOPRIL 5MG TABLET / ORAL AB 2020-09-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212041-003 LISINOPRIL 10MG TABLET / ORAL AB 2020-09-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212041-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2020-09-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212041-002 LISINOPRIL 5MG TABLET / ORAL AB 2020-09-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212041-003 LISINOPRIL 10MG TABLET / ORAL AB 2020-09-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212041-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2020-09-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212041-002 LISINOPRIL 5MG TABLET / ORAL AB 2020-09-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212041-003 LISINOPRIL 10MG TABLET / ORAL AB 2020-09-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212041-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2020-09-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212041-002 LISINOPRIL 5MG TABLET / ORAL AB 2020-09-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212041-003 LISINOPRIL 10MG TABLET / ORAL AB 2020-09-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212041-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2020-09-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212041-002 LISINOPRIL 5MG TABLET / ORAL AB 2020-09-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212041-003 LISINOPRIL 10MG TABLET / ORAL AB 2020-09-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212041-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2020-09-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212041-002 LISINOPRIL 5MG TABLET / ORAL AB 2020-09-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212041-003 LISINOPRIL 10MG TABLET / ORAL AB 2020-09-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212041-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2020-09-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212041-002 LISINOPRIL 5MG TABLET / ORAL AB 2020-09-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212041-003 LISINOPRIL 10MG TABLET / ORAL AB 2020-09-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212041-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2020-09-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212041-002 LISINOPRIL 5MG TABLET / ORAL AB 2020-09-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212041-003 LISINOPRIL 10MG TABLET / ORAL AB 2020-09-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212041-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2020-09-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212041-002 LISINOPRIL 5MG TABLET / ORAL AB 2020-09-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212041-003 LISINOPRIL 10MG TABLET / ORAL AB 2020-09-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212041-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2020-09-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212041-002 LISINOPRIL 5MG TABLET / ORAL AB 2020-09-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212041-003 LISINOPRIL 10MG TABLET / ORAL AB 2020-09-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212041-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2020-09-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212041-002 LISINOPRIL 5MG TABLET / ORAL AB 2020-09-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212041-003 LISINOPRIL 10MG TABLET / ORAL AB 2020-09-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212041-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2020-09-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212041-002 LISINOPRIL 5MG TABLET / ORAL AB 2020-09-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212041-003 LISINOPRIL 10MG TABLET / ORAL AB 2020-09-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212041-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2020-09-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212041-002 LISINOPRIL 5MG TABLET / ORAL AB 2020-09-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212041-003 LISINOPRIL 10MG TABLET / ORAL AB 2020-09-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212041-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2020-09-15 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 111 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69117-0038-1 Lisinopril 30 in 1 BOTTLE TABLET 30 5 69117-0038-2 Lisinopril 90 in 1 BOTTLE TABLET 90 5 69117-0038-3 Lisinopril 100 in 1 BOTTLE TABLET 100 5 69117-0038-4 Lisinopril 500 in 1 BOTTLE TABLET 500 5 69117-0038-5 Lisinopril 1000 in 1 BOTTLE TABLET 1000 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69117-0038 LISINOPRIL TABLET [YILING PHARMACEUTICAL, INC.] 5 Legacy NDC, 5 package rows 20230706_b2e928d0-1dfb-4dc0-8c62-ca4fc1f92228.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lisinopril LISINOPRIL Chartwell RX, LLC 8824e5e5-ed35-4a95-bfd6-98a2e7c4bbce 2025-12-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 212041 application number: ANDA212041
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 69117-0038-5 69117003805 1000 TABLET in 1 BOTTLE (69117-0038-5) 1000 tablet 2020-09-15 0000-00-00 No No Current