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 1 of 5 · 162 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-05-31 18:47 UTC2024-05A202554-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202554-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202554-003AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202554-004AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202554-005AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202554-006AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202554-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202554-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202554-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202554-004AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202554-005AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202554-006AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202554-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202554-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202554-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202554-004AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202554-005AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202554-006AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202554-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202554-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202554-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202554-004AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202554-005AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202554-006AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202554-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202554-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202554-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202554-004AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202554-005AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202554-006AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202554-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202554-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202554-003AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202554-004AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202554-005AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202554-006AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202554-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A202554-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A202554-003AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A202554-004AB1782e0a99824c…

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 2 of 8 · 156 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LisinoprilLISINOPRILPD-Rx Pharmaceuticals, Inc.c621c33b-cb67-4ea6-b2bd-96c20a244ea42026-06-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lisinopril
generic name: LISINOPRIL
LISINOPRILLISINOPRILNuCare Pharmaceuticals, Inc.4b6dc0d4-4acd-3606-e054-00144ff8d46c2026-06-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LISINOPRIL
generic name: LISINOPRIL
LisinoprilLISINOPRILCoupler LLC538429b8-4f10-e825-e063-6294a90a59052026-06-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lisinopril
generic name: LISINOPRIL
LISINOPRILLISINOPRILPreferred Pharmaceuticals Inc.ab561d21-7466-4d8b-8d06-291c1d4d82ff2026-05-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LISINOPRIL
generic name: LISINOPRIL
LISINOPRILLISINOPRILPreferred Pharmaceuticals Inc.7e297133-669e-4780-a966-c777624e54272026-05-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LISINOPRIL
generic name: LISINOPRIL
LISINOPRILLISINOPRILPreferred Pharmaceuticals Inc.affd3e43-077e-42e5-a865-c961624bfe932026-05-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LISINOPRIL
generic name: LISINOPRIL
LISINOPRILLISINOPRILPreferred Pharmaceuticals Inc.02c23f9c-f3cf-4366-ae1e-56296f1fedf92026-05-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LISINOPRIL
generic name: LISINOPRIL
LISINOPRILLISINOPRILPreferred Pharmaceuticals, Inc.74415f95-74c9-4329-a6af-a0f165bf78872026-05-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LISINOPRIL
generic name: LISINOPRIL
LisinoprilLISINOPRILCardinal Health 107, LLC1d0caa63-9ea2-4a97-a23b-900a7c514bc62026-05-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lisinopril
generic name: LISINOPRIL
LisinoprilLISINOPRILCoupler LLC518a63e3-8ca1-bbd1-e063-6294a90aa5242026-05-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lisinopril
generic name: LISINOPRIL
LisinoprilLISINOPRILCoupler LLC509a46cf-7a89-b6c0-e063-6394a90a75092026-04-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lisinopril
generic name: LISINOPRIL
LisinoprilLISINOPRILBryant Ranch Prepack08b0555e-41d2-44c3-b27b-ad5d701378dc2026-04-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lisinopril
generic name: LISINOPRIL
LisinoprilLISINOPRILBryant Ranch Prepack59fd2167-4da4-9143-83bd-3b6aa50515112026-03-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lisinopril
generic name: LISINOPRIL
LISINOPRILLISINOPRILA-S Medication Solutionsf57bd658-05d8-475a-ae74-87d2c78664172026-03-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LISINOPRIL
generic name: LISINOPRIL
LISINOPRILLISINOPRILA-S Medication Solutions176c744a-d4e3-4a4b-ac62-4fbcb1d8d7bf2026-03-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LISINOPRIL
generic name: LISINOPRIL
LISINOPRILLISINOPRILA-S Medication Solutionsbd804d65-742a-4890-ac9d-bee69968387d2026-03-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LISINOPRIL
generic name: LISINOPRIL
LisinoprilLISINOPRILLegacy Pharmaceutical Packaging, LLCf5db9549-e179-3db6-e053-2995a90a15442026-03-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lisinopril
generic name: LISINOPRIL
LISINOPRILLISINOPRILA-S Medication Solutions11a83bbc-9871-4df8-b3f2-7aba5149f3fe2026-03-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LISINOPRIL
generic name: LISINOPRIL
LISINOPRILLISINOPRILProficient Rx LPeddec313-910c-4bf1-9095-2153db53bc6e2026-03-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LISINOPRIL
generic name: LISINOPRIL
LISINOPRILLISINOPRILProficient Rx LP350c6fc9-9774-4d49-9242-19e96944f83b2026-03-01Boxed 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