FDA.reportPublic FDA data

Application 076180

Type
ANDA
Sponsor
PRINSTON INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LISINOPRILLISINOPRILTABLET;ORAL2.5MGNoNo
002LISINOPRILLISINOPRILTABLET;ORAL5MGNoNo
003LISINOPRILLISINOPRILTABLET;ORAL10MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2019-12-13 00:20 UTC2019-12A076180-001LISINOPRIL2.5MGTABLET / ORALAB2002-07-0174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076180-002LISINOPRIL5MGTABLET / ORALAB2002-07-0174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076180-003LISINOPRIL10MGTABLET / ORALAB2002-07-0174a2ff9319b5…
2020-11-12 02:37 UTC2020-11A076180-001LISINOPRIL2.5MGTABLET / ORALAB2002-07-01c0c555d07b60…
2020-11-12 02:37 UTC2020-11A076180-002LISINOPRIL5MGTABLET / ORALAB2002-07-01c0c555d07b60…
2020-11-12 02:37 UTC2020-11A076180-003LISINOPRIL10MGTABLET / ORALAB2002-07-01c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076180-001LISINOPRIL2.5MGTABLET / ORALAB2002-07-013f01610625f2…
2019-12-14 00:12 UTC2019-12A076180-002LISINOPRIL5MGTABLET / ORALAB2002-07-013f01610625f2…
2019-12-14 00:12 UTC2019-12A076180-003LISINOPRIL10MGTABLET / ORALAB2002-07-013f01610625f2…
2019-09-15 20:21 UTC2019-09A076180-001LISINOPRIL2.5MGTABLET / ORALAB2002-07-01b00525d2431f…
2019-09-15 20:21 UTC2019-09A076180-002LISINOPRIL5MGTABLET / ORALAB2002-07-01b00525d2431f…
2019-09-15 20:21 UTC2019-09A076180-003LISINOPRIL10MGTABLET / ORALAB2002-07-01b00525d2431f…
2019-07-19 19:46 UTC2019-07A076180-001LISINOPRIL2.5MGTABLET / ORALAB2002-07-01ea99ee380514…
2019-07-19 19:46 UTC2019-07A076180-002LISINOPRIL5MGTABLET / ORALAB2002-07-01ea99ee380514…
2019-07-19 19:46 UTC2019-07A076180-003LISINOPRIL10MGTABLET / ORALAB2002-07-01ea99ee380514…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A076180-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076180-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076180-003AB174a2ff9319b5…
2020-11-12 02:37 UTC2020-11A076180-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A076180-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A076180-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076180-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076180-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076180-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076180-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076180-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076180-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076180-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076180-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076180-003AB1ea99ee380514…

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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LISINOPRILLISINOPRILAphena Pharma Solutions - Tennessee, LLC6ba2c7d6-bc9e-4d8b-8d1e-c140047506932021-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076180
application number: ANDA076180
ndc (product): 71610-588

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 2 of 3 · 163 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63187-534LISINOPRILLisinoprilProficient Rx LPANDACurrent
63187-534LISINOPRILLisinoprilProficient Rx LPANDACurrent
63187-780LISINOPRILLisinoprilProficient Rx LPANDACurrent
63187-780LISINOPRILLisinoprilProficient Rx LPANDACurrent
63187-821LISINOPRILLisinoprilProficient Rx LPANDACurrent
63187-821LISINOPRILLisinoprilProficient Rx LPANDACurrent
63187-821LISINOPRILLisinoprilProficient Rx LPANDACurrent
63187-821LISINOPRILLisinoprilProficient Rx LPANDACurrent
63629-6836LISINOPRILLisinoprilBryant Ranch PrepackANDACurrent
67296-1249LISINOPRILLISINOPRILRedPharm Drug, Inc.ANDACurrent
67296-1249LISINOPRILLISINOPRILRedPharm Drug, Inc.ANDACurrent
67296-1249LISINOPRILLISINOPRILRedPharm Drug, Inc.ANDACurrent
68071-1672LISINOPRILLisinoprilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1672LISINOPRILLisinoprilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1672LISINOPRILLisinoprilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1894LISINOPRILLisinoprilNuCare Pharmaceuticals, IANDACurrent
68071-1894LISINOPRILLisinoprilNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1894LISINOPRILLisinoprilNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3122LISINOPRILLisinoprilNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3122LISINOPRILLisinoprilNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3123LISINOPRILLisinoprilNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3123LISINOPRILLisinoprilNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3123LISINOPRILLisinoprilNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4858LISINOPRILLisinoprilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4858LISINOPRILLisinoprilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5046LISINOPRILLisinoprilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5046LISINOPRILLisinoprilNuCare Pharmaceuticals,Inc.ANDACurrent
68788-6407LISINOPRILLisinoprilPreferred Pharmaceuticals Inc.ANDACurrent
68788-6407LISINOPRILLisinoprilPreferred Pharmaceuticals Inc.ANDACurrent
68788-6407LISINOPRILLisinoprilPreferred Pharmaceuticals Inc.ANDACurrent
68788-6407LISINOPRILLisinoprilPreferred Pharmaceuticals Inc.ANDACurrent
68788-6407LISINOPRILLisinoprilPreferred Pharmaceuticals Inc.ANDACurrent
68788-6820LISINOPRILLisinoprilPreferred Pharmaceuticals, Inc.ANDACurrent
68788-6820LISINOPRILLisinoprilPreferred Pharmaceuticals, Inc.ANDACurrent
68788-6820LISINOPRILLisinoprilPreferred Pharmaceuticals, Inc.ANDACurrent
68788-6820LISINOPRILLisinoprilPreferred Pharmaceuticals, Inc.ANDACurrent
68788-6820LISINOPRILLisinoprilPreferred Pharmaceuticals, Inc.ANDACurrent
68788-6898LISINOPRILLisinoprilPreferred Pharmaceuticals Inc.ANDACurrent
68788-6898LISINOPRILLisinoprilPreferred Pharmaceuticals Inc.ANDACurrent
68788-6898LISINOPRILLisinoprilPreferred Pharmaceuticals Inc.ANDACurrent
70518-0117LISINOPRILLisinoprilREMEDYREPACK INC.ANDACurrent
70518-0117LISINOPRILLisinoprilREMEDYREPACK INC.ANDACurrent
70518-0117LISINOPRILLisinoprilREMEDYREPACK INC.ANDACurrent
70518-0117LISINOPRILLisinoprilREMEDYREPACK INC.ANDACurrent
70518-0117LISINOPRILLisinoprilREMEDYREPACK INC.ANDACurrent
70518-0117LISINOPRILLisinoprilREMEDYREPACK INC.ANDACurrent
70518-0117LISINOPRILLisinoprilREMEDYREPACK INC.ANDACurrent
70518-0530LISINOPRILLisinoprilREMEDYREPACK INC.ANDACurrent
70518-0530LISINOPRILLisinoprilREMEDYREPACK INC.ANDACurrent
70518-0530LISINOPRILLisinoprilREMEDYREPACK INC.ANDACurrent
70518-1528LISINOPRILLisinoprilREMEDYREPACK INC.ANDACurrent
70518-1528LISINOPRILLisinoprilREMEDYREPACK INC.ANDACurrent
70518-1528LISINOPRILLisinoprilREMEDYREPACK INC.ANDACurrent
70518-1790LISINOPRILLisinoprilREMEDYREPACK INC.ANDACurrent
70518-1790LISINOPRILLisinoprilREMEDYREPACK INC.ANDACurrent
70518-2600LISINOPRILLisinoprilREMEDYREPACK INC.ANDACurrent
70518-2600LISINOPRILLisinoprilREMEDYREPACK INC.ANDACurrent
70518-2600LISINOPRILLisinoprilREMEDYREPACK INC.ANDACurrent
70934-120LISINOPRILLisinoprilDenton Pharma, Inc. DBA NANDACurrent
70934-120LISINOPRILLisinoprilDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-120LISINOPRILLisinoprilDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-613LISINOPRILLisinoprilDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-720LISINOPRILLisinoprilDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71335-0176LISINOPRILLisinoprilBryant Ranch PrepackANDACurrent
71335-0176LISINOPRILLisinoprilBryant Ranch PrepackANDACurrent
71335-0176LISINOPRILLisinoprilBryant Ranch PrepackANDACurrent
71335-0176LISINOPRILLisinoprilBryant Ranch PrepackANDACurrent
71335-0498LISINOPRILLisinoprilBryant Ranch PrepackANDACurrent
71335-0498LISINOPRILLisinoprilBryant Ranch PrepackANDACurrent
71335-0498LISINOPRILLisinoprilBryant Ranch PrepackANDACurrent
71335-0498LISINOPRILLisinoprilBryant Ranch PrepackANDACurrent
71335-0536LISINOPRILLisinoprilBryant Ranch PrepackANDACurrent
71335-0536LISINOPRILLisinoprilBryant Ranch PrepackANDACurrent
71335-0536LISINOPRILLisinoprilBryant Ranch PrepackANDACurrent
71335-0536LISINOPRILLisinoprilBryant Ranch PrepackANDACurrent
71335-1295LISINOPRILLisinoprilBryant Ranch PrepackANDACurrent
71335-1295LISINOPRILLisinoprilBryant Ranch PrepackANDACurrent
71610-588LISINOPRILLisinoprilAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-612LISINOPRILLisinoprilAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-612LISINOPRILLisinoprilAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8873ORIG2003-04-11