Application 202554

Type
ANDA
Sponsor
ACCORD HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LISINOPRILLISINOPRILTABLET;ORAL2.5MGNoNo
002LISINOPRILLISINOPRILTABLET;ORAL5MGNoNo
003LISINOPRILLISINOPRILTABLET;ORAL10MGNoNo
004LISINOPRILLISINOPRILTABLET;ORAL20MGNoNo
005LISINOPRILLISINOPRILTABLET;ORAL30MGNoNo
006LISINOPRILLISINOPRILTABLET;ORAL40MGNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202554-001LISINOPRILLISINOPRIL2.5MGTABLET / ORAL2013-07-30
A202554-002LISINOPRILLISINOPRIL5MGTABLET / ORAL2013-07-30
A202554-003LISINOPRILLISINOPRIL10MGTABLET / ORAL2013-07-30
A202554-004LISINOPRILLISINOPRIL20MGTABLET / ORAL2013-07-30
A202554-005LISINOPRILLISINOPRIL30MGTABLET / ORAL2013-07-30
A202554-006LISINOPRILLISINOPRIL40MGTABLET / ORAL2013-07-30

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A202554-001LISINOPRIL2.5MGTABLET / ORAL2013-07-3084e616aacf4f…
2026-09-14 22:38:342026-08A202554-002LISINOPRIL5MGTABLET / ORAL2013-07-3084e616aacf4f…
2026-09-14 22:38:342026-08A202554-003LISINOPRIL10MGTABLET / ORAL2013-07-3084e616aacf4f…
2026-09-14 22:38:342026-08A202554-004LISINOPRIL20MGTABLET / ORAL2013-07-3084e616aacf4f…
2026-09-14 22:38:342026-08A202554-005LISINOPRIL30MGTABLET / ORAL2013-07-3084e616aacf4f…
2026-09-14 22:38:342026-08A202554-006LISINOPRIL40MGTABLET / ORAL2013-07-3084e616aacf4f…
2026-08-18 06:07:402026-07A202554-001LISINOPRIL2.5MGTABLET / ORAL2013-07-30caaa826d4ba7…
2026-08-18 06:07:402026-07A202554-002LISINOPRIL5MGTABLET / ORAL2013-07-30caaa826d4ba7…
2026-08-18 06:07:402026-07A202554-003LISINOPRIL10MGTABLET / ORAL2013-07-30caaa826d4ba7…
2026-08-18 06:07:402026-07A202554-004LISINOPRIL20MGTABLET / ORAL2013-07-30caaa826d4ba7…
2026-08-18 06:07:402026-07A202554-005LISINOPRIL30MGTABLET / ORAL2013-07-30caaa826d4ba7…
2026-08-18 06:07:402026-07A202554-006LISINOPRIL40MGTABLET / ORAL2013-07-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202554-001LISINOPRIL2.5MGTABLET / ORAL2013-07-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202554-002LISINOPRIL5MGTABLET / ORAL2013-07-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202554-003LISINOPRIL10MGTABLET / ORAL2013-07-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202554-004LISINOPRIL20MGTABLET / ORAL2013-07-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202554-005LISINOPRIL30MGTABLET / ORAL2013-07-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202554-006LISINOPRIL40MGTABLET / ORAL2013-07-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202554-001LISINOPRIL2.5MGTABLET / ORAL2013-07-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202554-002LISINOPRIL5MGTABLET / ORAL2013-07-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202554-003LISINOPRIL10MGTABLET / ORAL2013-07-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202554-004LISINOPRIL20MGTABLET / ORAL2013-07-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202554-005LISINOPRIL30MGTABLET / ORAL2013-07-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202554-006LISINOPRIL40MGTABLET / ORAL2013-07-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A202554-001LISINOPRIL2.5MGTABLET / ORAL2013-07-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202554-002LISINOPRIL5MGTABLET / ORAL2013-07-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202554-003LISINOPRIL10MGTABLET / ORAL2013-07-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202554-004LISINOPRIL20MGTABLET / ORAL2013-07-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202554-005LISINOPRIL30MGTABLET / ORAL2013-07-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202554-006LISINOPRIL40MGTABLET / ORAL2013-07-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202554-001LISINOPRIL2.5MGTABLET / ORAL2013-07-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202554-002LISINOPRIL5MGTABLET / ORAL2013-07-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202554-003LISINOPRIL10MGTABLET / ORAL2013-07-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202554-004LISINOPRIL20MGTABLET / ORAL2013-07-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202554-005LISINOPRIL30MGTABLET / ORAL2013-07-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202554-006LISINOPRIL40MGTABLET / ORAL2013-07-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202554-001LISINOPRIL2.5MGTABLET / ORAL2013-07-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202554-002LISINOPRIL5MGTABLET / ORAL2013-07-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202554-003LISINOPRIL10MGTABLET / ORAL2013-07-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202554-004LISINOPRIL20MGTABLET / ORAL2013-07-30b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 5 · 162 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-07-19 19:46 UTC2019-07A202554-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A202554-004AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A202554-005AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A202554-006AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202554-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202554-002AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202554-003AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202554-004AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202554-005AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202554-006AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202554-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A202554-002AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A202554-003AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A202554-004AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A202554-005AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A202554-006AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202554-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A202554-002AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A202554-003AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A202554-004AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A202554-005AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A202554-006AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202554-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202554-002AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202554-003AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202554-004AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202554-005AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202554-006AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202554-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202554-002AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202554-003AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202554-004AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202554-005AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202554-006AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202554-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202554-002AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202554-003AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202554-004AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202554-005AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202554-006AB1a67488948f0b…

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 8 · 156 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LisinoprilLISINOPRILREMEDYREPACK INC.aa5d68e7-c2b9-41eb-ade4-2cd57edc15332026-09-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lisinopril
generic name: LISINOPRIL
LisinoprilLISINOPRILREMEDYREPACK INC.463308ef-16cb-41d8-8d29-6aae2c5a7b0f2026-08-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lisinopril
generic name: LISINOPRIL
LisinoprilLISINOPRILREMEDYREPACK INC.34bb4602-ccff-4939-91b9-26a63bfd40f72026-08-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lisinopril
generic name: LISINOPRIL
LisinoprilLISINOPRILAurobindo Pharma Limited0e6364a4-6d66-4151-8197-d45e2a7628952026-07-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lisinopril
generic name: LISINOPRIL
LISINOPRILLISINOPRILSt. Mary's Medical Park Pharmacy6051cc96-86e0-bd0b-e053-2a91aa0a5dcf2026-07-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LISINOPRIL
generic name: LISINOPRIL
LisinoprilLISINOPRILREMEDYREPACK INC.a33d860a-1e17-45b7-aede-51ab3223bebd2026-07-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lisinopril
generic name: LISINOPRIL
LISINOPRILLISINOPRILREMEDYREPACK INC.42f49299-7ae5-4d30-86eb-66b739c0e95d2026-07-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LISINOPRIL
generic name: LISINOPRIL
LISINOPRILLISINOPRILREMEDYREPACK INC.12d6fe7e-b5a2-4d49-9a06-a6150234d0612026-07-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LISINOPRIL
generic name: LISINOPRIL
LISINOPRILLISINOPRILCoupler LLC560513ef-4d2c-8ca0-e063-6394a90a674a2026-07-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LISINOPRIL
generic name: LISINOPRIL
LisinoprilLISINOPRILA-S Medication Solutions88b5a2c0-6ad2-48e7-9ffe-715d9159f3892026-07-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lisinopril
generic name: LISINOPRIL
LisinoprilLISINOPRILA-S Medication Solutions34953f77-bae1-41fe-af11-3ea0b3ceaa112026-07-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lisinopril
generic name: LISINOPRIL
LisinoprilLISINOPRILREMEDYREPACK INC.3451292b-7867-4dc2-afaa-da66b40160172026-07-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lisinopril
generic name: LISINOPRIL
LisinoprilLISINOPRILREMEDYREPACK INC.d32923fe-a323-43c6-af46-bcba7274b0bf2026-07-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lisinopril
generic name: LISINOPRIL
LISINOPRILLISINOPRILREMEDYREPACK INC.e17bcc2e-f5ed-4846-95d3-a5479c7fee8d2026-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LISINOPRIL
generic name: LISINOPRIL
LISINOPRILLISINOPRILSt. Mary's Medical Park Pharmacy6062fd98-7663-f4b5-e053-2a91aa0acbc32026-06-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LISINOPRIL
generic name: LISINOPRIL
LISINOPRILLISINOPRILSt. Mary's Medical Park Pharmacy5f4c1a62-fb84-8cdc-e053-2a91aa0a671a2026-06-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LISINOPRIL
generic name: LISINOPRIL
LisinoprilLISINOPRILUnit Dose Solutions, Inc.551665a0-9a92-55df-e063-6394a90a1e2e2026-06-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lisinopril
generic name: LISINOPRIL
LisinoprilLISINOPRILUnit Dose Solutions, Inc.55189717-f5db-9c63-e063-6294a90a6bc92026-06-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lisinopril
generic name: LISINOPRIL
LisinoprilLISINOPRILUnit Dose Solutions, Inc.55191baa-f812-2e71-e063-6294a90a8edf2026-06-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lisinopril
generic name: LISINOPRIL
LISINOPRILLISINOPRILSt. Mary's Medical Park Pharmacy5eff766f-82e2-4cd6-e053-2a91aa0a47822026-06-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LISINOPRIL
generic name: LISINOPRIL

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 49 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-7966LISINOPRILLisinoprilNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7980LISINOPRILLisinoprilNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7981LISINOPRILLisinoprilNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8053LisinoprilLisinoprilNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8054LISINOPRILLisinoprilNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8057LisinoprilLisinoprilNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
16729-375LISINOPRILLisinoprilAccord Healthcare Inc.ANDACurrent
16729-375LISINOPRILLisinoprilAccord Healthcare Inc.ANDACurrent
16729-375LISINOPRILLisinoprilAccord Healthcare Inc.ANDACurrent
16729-376LISINOPRILLisinoprilAccord Healthcare Inc.ANDACurrent
16729-376LISINOPRILLisinoprilAccord Healthcare Inc.ANDACurrent
16729-376LISINOPRILLisinoprilAccord Healthcare Inc.ANDACurrent
16729-377LISINOPRILLisinoprilAccord Healthcare Inc.ANDACurrent
16729-377LISINOPRILLisinoprilAccord Healthcare Inc.ANDACurrent
16729-377LISINOPRILLisinoprilAccord Healthcare Inc.ANDACurrent
16729-378LISINOPRILLisinoprilAccord Healthcare Inc.ANDACurrent
16729-378LISINOPRILLisinoprilAccord Healthcare Inc.ANDACurrent
16729-378LISINOPRILLisinoprilAccord Healthcare Inc.ANDACurrent
16729-379LISINOPRILLisinoprilAccord Healthcare Inc.ANDACurrent
16729-379LISINOPRILLisinoprilAccord Healthcare Inc.ANDACurrent
16729-379LISINOPRILLisinoprilAccord Healthcare Inc.ANDACurrent
16729-380LISINOPRILLisinoprilAccord Healthcare Inc.ANDACurrent
16729-380LISINOPRILLisinoprilAccord Healthcare Inc.ANDACurrent
16729-380LISINOPRILLisinoprilAccord Healthcare Inc.ANDACurrent
50090-2743LISINOPRILLisinoprilA-S Medication SolutionsANDACurrent
50436-0376LISINOPRILLisinoprilUnit Dose ServicesANDACurrent
61919-332LISINOPRILLISINOPRILDirectRXANDACurrent
61919-561LISINOPRILLISINOPRILDIRECT RXANDACurrent
61919-561LISINOPRILLISINOPRILDIRECT RXANDACurrent
66267-577LISINOPRILLisinoprilNuCare Pharmaceuticals, Inc.ANDACurrent
66267-577LISINOPRILLisinoprilNuCare Pharmaceuticals, Inc.ANDACurrent
66267-578LISINOPRILLisinoprilNuCare Pharmaceuticals, Inc.ANDACurrent
66267-578LISINOPRILLisinoprilNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3113LISINOPRILLisinoprilNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3145LISINOPRILLisinoprilNuCare Pharmaceuticals, Inc.ANDACurrent
68788-6373LISINOPRILLisinoprilPreferred Pharmaceuticals Inc.ANDACurrent
68788-6373LISINOPRILLisinoprilPreferred Pharmaceuticals Inc.ANDACurrent
68788-6373LISINOPRILLisinoprilPreferred Pharmaceuticals Inc.ANDACurrent
68788-6418LISINOPRILLisinoprilPreferred Pharmaceuticals Inc.ANDACurrent
68788-6782LISINOPRILLisinoprilPreferred Pharmaceuticals, Inc.ANDACurrent
68788-6811LISINOPRILLisinoprilPreferred Pharmaceuticals Inc.ANDACurrent
68788-6811LISINOPRILLisinoprilPreferred Pharmaceuticals Inc.ANDACurrent
68788-6811LISINOPRILLisinoprilPreferred Pharmaceuticals Inc.ANDACurrent
68788-6811LISINOPRILLisinoprilPreferred Pharmaceuticals Inc.ANDACurrent
68788-8912LISINOPRILLisinoprilPreferred Pharmaceuticals Inc.ANDACurrent
68788-8912LISINOPRILLisinoprilPreferred Pharmaceuticals Inc.ANDACurrent
68788-8912LISINOPRILLisinoprilPreferred Pharmaceuticals Inc.ANDACurrent
70518-0047LISINOPRILLisinoprilREMEDYREPACK INC.ANDACurrent
71335-0261LISINOPRILLisinoprilBryant Ranch PrepackANDACurrent