Application 076059

Type
ANDA
Sponsor
WATSON LABS

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
A076059-001LISINOPRILLISINOPRIL2.5MGTABLET / ORALAB2002-07-01
A076059-002LISINOPRILLISINOPRIL5MGTABLET / ORALAB2002-07-01
A076059-003LISINOPRILLISINOPRIL10MGTABLET / ORALAB2002-07-01
A076059-004LISINOPRILLISINOPRIL20MGTABLET / ORALAB2002-07-01
A076059-005LISINOPRILLISINOPRIL30MGTABLET / ORALAB2002-07-01
A076059-006LISINOPRILLISINOPRIL40MGTABLET / 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
A076059-001AB
A076059-002AB
A076059-003AB
A076059-004AB
A076059-005AB
A076059-006AB

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 06:07:402026-07A076059-001LISINOPRIL2.5MGTABLET / ORALAB2002-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A076059-002LISINOPRIL5MGTABLET / ORALAB2002-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A076059-003LISINOPRIL10MGTABLET / ORALAB2002-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A076059-004LISINOPRIL20MGTABLET / ORALAB2002-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A076059-005LISINOPRIL30MGTABLET / ORALAB2002-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A076059-006LISINOPRIL40MGTABLET / ORALAB2002-07-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076059-001LISINOPRIL2.5MGTABLET / ORALAB2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076059-002LISINOPRIL5MGTABLET / ORALAB2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076059-003LISINOPRIL10MGTABLET / ORALAB2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076059-004LISINOPRIL20MGTABLET / ORALAB2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076059-005LISINOPRIL30MGTABLET / ORALAB2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076059-006LISINOPRIL40MGTABLET / ORALAB2002-07-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076059-001LISINOPRIL2.5MGTABLET / ORALAB2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076059-002LISINOPRIL5MGTABLET / ORALAB2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076059-003LISINOPRIL10MGTABLET / ORALAB2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076059-004LISINOPRIL20MGTABLET / ORALAB2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076059-005LISINOPRIL30MGTABLET / ORALAB2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076059-006LISINOPRIL40MGTABLET / ORALAB2002-07-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076059-001LISINOPRIL2.5MGTABLET / ORALAB2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076059-002LISINOPRIL5MGTABLET / ORALAB2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076059-003LISINOPRIL10MGTABLET / ORALAB2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076059-004LISINOPRIL20MGTABLET / ORALAB2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076059-005LISINOPRIL30MGTABLET / ORALAB2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076059-006LISINOPRIL40MGTABLET / ORALAB2002-07-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076059-001LISINOPRIL2.5MGTABLET / ORALAB2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076059-002LISINOPRIL5MGTABLET / ORALAB2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076059-003LISINOPRIL10MGTABLET / ORALAB2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076059-004LISINOPRIL20MGTABLET / ORALAB2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076059-005LISINOPRIL30MGTABLET / ORALAB2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076059-006LISINOPRIL40MGTABLET / ORALAB2002-07-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076059-001LISINOPRIL2.5MGTABLET / ORALAB2002-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076059-002LISINOPRIL5MGTABLET / ORALAB2002-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076059-003LISINOPRIL10MGTABLET / ORALAB2002-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076059-004LISINOPRIL20MGTABLET / ORALAB2002-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076059-005LISINOPRIL30MGTABLET / ORALAB2002-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076059-006LISINOPRIL40MGTABLET / ORALAB2002-07-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076059-001LISINOPRIL2.5MGTABLET / ORALAB2002-07-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076059-002LISINOPRIL5MGTABLET / ORALAB2002-07-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076059-003LISINOPRIL10MGTABLET / ORALAB2002-07-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076059-004LISINOPRIL20MGTABLET / 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 06:07:402026-07A076059-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076059-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076059-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076059-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076059-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076059-006AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076059-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076059-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076059-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076059-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076059-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076059-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076059-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076059-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076059-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076059-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076059-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076059-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076059-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076059-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076059-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076059-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076059-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076059-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076059-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076059-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076059-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076059-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076059-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076059-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076059-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076059-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076059-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076059-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076059-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076059-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076059-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076059-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076059-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076059-004AB103ed91905a0d…

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LisinoprilLISINOPRILQPharma Incb17cd16b-8d0a-4cfa-bd48-2529983fcd122025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076059
application number: ANDA076059
ndc (product): 42708-031
ndc (product): 42708-033
ndc (product): 42708-032
LisinoprilLISINOPRILNuCare Pharmaceuticals,Inc.964c7f28-f62e-30b5-e053-2a95a90ab84c2025-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076059
application number: ANDA076059
LisinoprilLISINOPRILBryant Ranch Prepack33ebf3f2-cd71-4d8b-ac22-1a20a068a13d2024-10-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076059
application number: ANDA076059
LisinoprilLISINOPRILNuCare Pharmaceuticals,Inc.ab9bc1b4-60cc-76ea-e053-2995a90ac2032024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076059
application number: ANDA076059
LisinoprilLISINOPRILNuCare Pharmaceuticals,Inc.90a589a9-acc2-bfbe-e053-2995a90a0bd22024-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076059
application number: ANDA076059
LisinoprilLISINOPRILNuCare Pharmaceuticals,Inc.95376981-4620-c9aa-e053-2995a90a13902024-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076059
application number: ANDA076059
LisinoprilLISINOPRILBryant Ranch Prepack3783ab4c-2bed-414e-8927-62d47e3e34962024-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076059
application number: ANDA076059
ndc (product): 63629-8823
LisinoprilLISINOPRILBryant Ranch Prepack5af2444f-438c-4ea6-96e8-3dba1af9e1a52024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076059
application number: ANDA076059
ndc (product): 63629-8736
LisinoprilLISINOPRILProficient Rx LP8a14eaa6-cb8b-4088-ba15-840b587ab1f72022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076059
application number: ANDA076059
ndc (product): 63187-442
LisinoprilLISINOPRILProficient Rx LP55a57d80-6bed-44a3-b3ea-6bb44c34cbfc2021-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076059
application number: ANDA076059
LisinoprilLISINOPRILActavis Pharma, Inc.43e2c8d1-3704-4323-bcaf-f582572b81f72017-11-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076059
application number: ANDA076059
ndc (product): 0591-0885
ndc (product): 0591-0406
ndc (product): 0591-0405
ndc (product): 0591-0408
ndc (product): 0591-0409
ndc (product): 0591-0407

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 123 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0591-0405LisinoprilLisinoprilActavis Pharma, Inc.ANDACurrent
0591-0405LisinoprilLisinoprilActavis Pharma, Inc.ANDACurrent
0591-0405LisinoprilLisinoprilActavis Pharma, Inc.ANDACurrent
0591-0405LisinoprilLisinoprilActavis Pharma, Inc.ANDACurrent
0591-0405LisinoprilLisinoprilActavis Pharma, Inc.ANDACurrent
0591-0406LisinoprilLisinoprilActavis Pharma, Inc.ANDACurrent
0591-0406LisinoprilLisinoprilActavis Pharma, Inc.ANDACurrent
0591-0406LisinoprilLisinoprilActavis Pharma, Inc.ANDACurrent
0591-0406LisinoprilLisinoprilActavis Pharma, Inc.ANDACurrent
0591-0406LisinoprilLisinoprilActavis Pharma, Inc.ANDACurrent
0591-0407LisinoprilLisinoprilActavis Pharma, Inc.ANDACurrent
0591-0407LisinoprilLisinoprilActavis Pharma, Inc.ANDACurrent
0591-0407LisinoprilLisinoprilActavis Pharma, Inc.ANDACurrent
0591-0407LisinoprilLisinoprilActavis Pharma, Inc.ANDACurrent
0591-0407LisinoprilLisinoprilActavis Pharma, Inc.ANDACurrent
0591-0408LisinoprilLisinoprilActavis Pharma, Inc.ANDACurrent
0591-0408LisinoprilLisinoprilActavis Pharma, Inc.ANDACurrent
0591-0408LisinoprilLisinoprilActavis Pharma, Inc.ANDACurrent
0591-0408LisinoprilLisinoprilActavis Pharma, Inc.ANDACurrent
0591-0408LisinoprilLisinoprilActavis Pharma, Inc.ANDACurrent
0591-0409LisinoprilLisinoprilActavis Pharma, Inc.ANDACurrent
0591-0409LisinoprilLisinoprilActavis Pharma, Inc.ANDACurrent
0591-0409LisinoprilLisinoprilActavis Pharma, Inc.ANDACurrent
0591-0409LisinoprilLisinoprilActavis Pharma, Inc.ANDACurrent
0591-0409LisinoprilLisinoprilActavis Pharma, Inc.ANDACurrent
0591-0885LisinoprilLisinoprilActavis Pharma, Inc.ANDACurrent
0591-0885LisinoprilLisinoprilActavis Pharma, Inc.ANDACurrent
0591-0885LisinoprilLisinoprilActavis Pharma, Inc.ANDACurrent
0591-0885LisinoprilLisinoprilActavis Pharma, Inc.ANDACurrent
0591-0885LisinoprilLisinoprilActavis Pharma, Inc.ANDACurrent
21695-328LisinoprilLisinoprilRebel Distributors CorpANDACurrent
21695-329LisinoprilLisinoprilRebel Distributors CorpANDACurrent
21695-330LisinoprilLisinoprilRebel Distributors CorpANDACurrent
21695-331LisinoprilLisinoprilRebel Distributors CorpANDACurrent
42708-031LisinoprilLisinoprilQPharma IncANDACurrent
42708-031LisinoprilLisinoprilQPharma IncANDACurrent
42708-031LisinoprilLisinoprilQPharma IncANDACurrent
42708-032LisinoprilLisinoprilQPharma IncANDACurrent
42708-032LisinoprilLisinoprilQPharma IncANDACurrent
42708-032LisinoprilLisinoprilQPharma IncANDACurrent
42708-033LisinoprilLisinoprilQPharma IncANDACurrent
42708-033LisinoprilLisinoprilQPharma IncANDACurrent
42708-033LisinoprilLisinoprilQPharma IncANDACurrent
50090-2753LisinoprilLisinoprilA-S Medication SolutionsANDACurrent
50090-3757LisinoprilLisinoprilA-S Medication SolutionsANDACurrent
50090-3757LisinoprilLisinoprilA-S Medication SolutionsANDACurrent
50090-4485LisinoprilLisinoprilA-S Medication SolutionsANDACurrent
50090-4678LisinoprilLisinoprilA-S Medication SolutionsANDACurrent
50090-4678LisinoprilLisinoprilA-S Medication SolutionsANDACurrent
51655-273LisinoprilLisinoprilNorthwind PharmaceuticalsANDACurrent
51655-273LisinoprilLisinoprilNorthwind PharmaceuticalsANDACurrent
51655-292LisinoprilLisinoprilNorthwind PharmaceuticalsANDACurrent
51655-292LISINOPRILLISINOPRILNorthwind Pharmaceuticals, LLCANDACurrent
51655-292LisinoprilLisinoprilNorthwind PharmaceuticalsANDACurrent
53808-0703LisinoprilLISINOPRILState of Florida DOH Central PharmacyANDACurrent
53808-0868LisinoprilLisinoprilState of Florida DOH Central PharmacyANDACurrent
55154-8128LisinoprilLisinoprilCardinal HealthANDACurrent
60760-380LisinoprilLisinoprilSt. Mary's Medical Park PharmacyANDACurrent
60760-390LisinoprilLisinoprilSt. Mary's Medical Park PharmacyANDACurrent
60760-438LisinoprilLisinoprilSt. Mary's Medical Park PharmacyANDACurrent
60760-438LisinoprilLisinoprilSt. Mary's Medical Park PharmacyANDACurrent
63187-442LisinoprilLisinoprilProficient Rx LPANDACurrent
63187-442LisinoprilLisinoprilProficient Rx LPANDACurrent
63187-442LisinoprilLisinoprilProficient Rx LPANDACurrent
63187-442LisinoprilLisinoprilProficient Rx LPANDACurrent
63629-2688LisinoprilLisinoprilBryant Ranch PrepackANDACurrent
63629-8079LisinoprilLisinoprilBryant Ranch PrepackANDACurrent
63629-8736LisinoprilLisinoprilBryant Ranch PrepackANDACurrent
63629-8736LisinoprilLisinoprilBryant Ranch PrepackANDACurrent
63629-8823LisinoprilLisinoprilBryant Ranch PrepackANDACurrent
63629-8823LisinoprilLisinoprilBryant Ranch PrepackANDACurrent
63739-349LisinoprilLisinoprilMcKesson Corporation dba SKY PackagingANDACurrent
63739-349LisinoprilLisinoprilMcKesson CorporationANDACurrent
63739-349LisinoprilLisinoprilMcKesson Corporation dba SKY PackagingANDACurrent
63739-350LisinoprilLisinoprilMcKesson Corporation dba SKY PackagingANDACurrent
63739-350LisinoprilLisinoprilMcKesson CorporationANDACurrent
63739-350LisinoprilLisinoprilMcKesson Corporation dba SKY PackagingANDACurrent
67046-419LisinoprilLisinoprilContract Pharmacy Services-PAANDACurrent
67296-1154LisinoprilLisinoprilRedPharm Drug, Inc.ANDACurrent
67296-1154LisinoprilLisinoprilRedPharm Drug, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8858ORIG2003-04-10