Application 075743

Type
ANDA
Sponsor
PRINSTON INC

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 42.

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
A075743-001LISINOPRILLISINOPRIL2.5MGTABLET / ORALAB2002-07-01
A075743-002LISINOPRILLISINOPRIL5MGTABLET / ORALAB2002-07-01
A075743-003LISINOPRILLISINOPRIL10MGTABLET / ORALAB2002-07-01
A075743-004LISINOPRILLISINOPRIL20MGTABLET / ORALAB2002-07-01
A075743-005LISINOPRILLISINOPRIL30MGTABLET / ORALAB2002-07-01
A075743-006LISINOPRILLISINOPRIL40MGTABLET / ORALAB2002-07-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
A075743-001AB
A075743-002AB
A075743-003AB
A075743-004AB
A075743-005AB
A075743-006AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A075743-001LISINOPRIL2.5MGTABLET / ORALAB2002-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A075743-002LISINOPRIL5MGTABLET / ORALAB2002-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A075743-003LISINOPRIL10MGTABLET / ORALAB2002-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A075743-004LISINOPRIL20MGTABLET / ORALAB2002-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A075743-005LISINOPRIL30MGTABLET / ORALAB2002-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A075743-006LISINOPRIL40MGTABLET / ORALAB2002-07-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075743-001LISINOPRIL2.5MGTABLET / ORALAB2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075743-002LISINOPRIL5MGTABLET / ORALAB2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075743-003LISINOPRIL10MGTABLET / ORALAB2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075743-004LISINOPRIL20MGTABLET / ORALAB2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075743-005LISINOPRIL30MGTABLET / ORALAB2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075743-006LISINOPRIL40MGTABLET / ORALAB2002-07-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075743-001LISINOPRIL2.5MGTABLET / ORALAB2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075743-002LISINOPRIL5MGTABLET / ORALAB2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075743-003LISINOPRIL10MGTABLET / ORALAB2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075743-004LISINOPRIL20MGTABLET / ORALAB2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075743-005LISINOPRIL30MGTABLET / ORALAB2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075743-006LISINOPRIL40MGTABLET / ORALAB2002-07-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075743-001LISINOPRIL2.5MGTABLET / ORALAB2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075743-002LISINOPRIL5MGTABLET / ORALAB2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075743-003LISINOPRIL10MGTABLET / ORALAB2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075743-004LISINOPRIL20MGTABLET / ORALAB2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075743-005LISINOPRIL30MGTABLET / ORALAB2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075743-006LISINOPRIL40MGTABLET / ORALAB2002-07-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075743-001LISINOPRIL2.5MGTABLET / ORALAB2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075743-002LISINOPRIL5MGTABLET / ORALAB2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075743-003LISINOPRIL10MGTABLET / ORALAB2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075743-004LISINOPRIL20MGTABLET / ORALAB2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075743-005LISINOPRIL30MGTABLET / ORALAB2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075743-006LISINOPRIL40MGTABLET / ORALAB2002-07-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075743-001LISINOPRIL2.5MGTABLET / ORALAB2002-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075743-002LISINOPRIL5MGTABLET / ORALAB2002-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075743-003LISINOPRIL10MGTABLET / ORALAB2002-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075743-004LISINOPRIL20MGTABLET / ORALAB2002-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075743-005LISINOPRIL30MGTABLET / ORALAB2002-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075743-006LISINOPRIL40MGTABLET / ORALAB2002-07-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075743-001LISINOPRIL2.5MGTABLET / ORALAB2002-07-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075743-002LISINOPRIL5MGTABLET / ORALAB2002-07-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075743-003LISINOPRIL10MGTABLET / ORALAB2002-07-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075743-004LISINOPRIL20MGTABLET / ORALAB2002-07-0103ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 252 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A075743-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075743-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075743-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075743-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075743-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075743-006AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075743-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075743-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075743-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075743-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075743-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075743-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075743-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075743-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075743-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075743-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075743-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075743-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075743-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075743-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075743-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075743-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075743-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075743-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075743-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075743-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075743-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075743-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075743-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075743-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075743-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075743-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075743-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075743-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075743-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075743-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075743-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075743-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075743-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075743-004AB103ed91905a0d…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LisinoprilLISINOPRILPD-Rx Pharmaceuticals, Inc.b62815f3-77fc-4074-a28a-918ab5cc32db2025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075743
application number: ANDA075743
ndc (product): 43063-812
ndc (product): 43063-813
ndc (product): 43063-810
ndc (product): 43063-811
ndc (product): 43063-814
ndc (product): 43063-815
LisinoprilLISINOPRILAphena Pharma Solutions - Tennessee, LLCa79a034d-7bbb-4b05-b8fc-8ebf09f33c0c2023-10-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075743
application number: ANDA075743
LisinoprilLISINOPRILSolco healthcare U.S., LLCf8d16c85-50e2-4d99-afae-6fb902734e422022-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075743
application number: ANDA075743
ndc (product): 43547-418
ndc (product): 43547-417
ndc (product): 43547-414
ndc (product): 43547-419
ndc (product): 43547-416
ndc (product): 43547-415
LisinoprilLISINOPRILAphena Pharma Solutions - Tennessee, LLC1c0250c7-ff57-411b-852b-b8e4573f20572020-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075743
application number: ANDA075743

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 104 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0603-4209LisinoprilLisinoprilPar PharmaceuticalANDACurrent
0603-4210LisinoprilLisinoprilPar PharmaceuticalANDACurrent
0603-4211LisinoprilLisinoprilPar PharmaceuticalANDACurrent
0603-4212LisinoprilLisinoprilPar PharmaceuticalANDACurrent
0603-4214LisinoprilLisinoprilPar PharmaceuticalANDACurrent
10544-585LisinoprilLisinoprilBlenheim Pharmacal, Inc.ANDACurrent
10544-623LisinoprilLisinoprilBlenheim Pharmacal, Inc.ANDACurrent
33261-110LisinoprilLisinoprilAidarex Pharmaceuticals LLCANDACurrent
35356-973LisinoprilLisinoprilLake Erie Medical DBA Quality Care Products LLCANDACurrent
42708-095LisinoprilLisinoprilQPharma IncANDACurrent
42708-095LisinoprilLisinoprilQPharma IncANDACurrent
43063-810LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-810LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-810LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-810LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-810LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-810LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-810LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-810LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-811LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-811LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-811LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-811LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-811LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-811LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-811LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-811LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-812LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-812LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-812LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-812LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-812LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-812LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-812LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-812LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-813LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-813LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-813LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-813LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-813LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-813LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-813LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-813LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-814LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-814LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-814LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-814LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-814LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-814LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-814LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-814LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-815LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-815LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-815LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-815LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-815LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-815LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-815LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-815LisinoprilLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43353-113LisinoprilLisinoprilAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-643LisinoprilLisinoprilAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-662LisinoprilLisinoprilAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-793LisinoprilLisinoprilAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-993LisinoprilLisinoprilAphena Pharma Solutions - Tennessee, LLCANDACurrent
43547-414LisinoprilLisinoprilSolco healthcare U.S., LLCANDACurrent
43547-414LisinoprilLisinoprilSolco healthcare U.S., LLCANDACurrent
43547-414LisinoprilLisinoprilSolco healthcare U.S., LLCANDACurrent
43547-415LisinoprilLisinoprilSolco healthcare U.S., LLCANDACurrent
43547-415LisinoprilLisinoprilSolco healthcare U.S., LLCANDACurrent
43547-415LisinoprilLisinoprilSolco healthcare U.S., LLCANDACurrent
43547-416LisinoprilLisinoprilSolco healthcare U.S., LLCANDACurrent
43547-416LisinoprilLisinoprilSolco healthcare U.S., LLCANDACurrent
43547-416LisinoprilLisinoprilSolco healthcare U.S., LLCANDACurrent
43547-417LisinoprilLisinoprilSolco healthcare U.S., LLCANDACurrent
43547-417LisinoprilLisinoprilSolco healthcare U.S., LLCANDACurrent
43547-417LisinoprilLisinoprilSolco healthcare U.S., LLCANDACurrent
43547-418LisinoprilLisinoprilSolco healthcare U.S., LLCANDACurrent
43547-418LisinoprilLisinoprilSolco healthcare U.S., LLCANDACurrent
43547-418LisinoprilLisinoprilSolco healthcare U.S., LLCANDACurrent
43547-419LisinoprilLisinoprilSolco healthcare U.S., LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8783ORIG2004-06-24