Home Applications 212041 Application 212041
Type ANDA
Sponsor YILING PHARM LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LISINOPRIL LISINOPRIL UNKNOWN UNKNOWN No No 002 LISINOPRIL LISINOPRIL TABLET;ORAL 5MG No No 003 LISINOPRIL LISINOPRIL TABLET;ORAL 10MG No No
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.
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
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 69117-0036 Lisinopril Lisinopril Yiling Pharmaceutical, Inc. ANDA Current 69117-0036 Lisinopril Lisinopril Yiling Pharmaceutical, Inc. ANDA Current 69117-0036 Lisinopril Lisinopril Yiling Pharmaceutical, Inc. ANDA Current 69117-0036 Lisinopril Lisinopril Yiling Pharmaceutical, Inc. ANDA Current 69117-0037 Lisinopril Lisinopril Yiling Pharmaceutical, Inc. ANDA Current 69117-0037 Lisinopril Lisinopril Yiling Pharmaceutical, Inc. ANDA Current 69117-0037 Lisinopril Lisinopril Yiling Pharmaceutical, Inc. ANDA Current 69117-0037 Lisinopril Lisinopril Yiling Pharmaceutical, Inc. ANDA Current 69117-0038 Lisinopril Lisinopril Yiling Pharmaceutical, Inc. ANDA Current 69117-0038 Lisinopril Lisinopril Yiling Pharmaceutical, Inc. ANDA Current 69117-0038 Lisinopril Lisinopril Yiling Pharmaceutical, Inc. ANDA Current 69117-0038 Lisinopril Lisinopril Yiling Pharmaceutical, Inc. ANDA Current