Zestril

Product NDC
52427-438
11-digit product format
524270438
Labeler code
52427
Product ID
52427-438_443df970-cabf-11ee-37bb-7912e4e6ac21
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
Almatica Pharma LLC
Application
NDA019777
Marketing category
NDA
Marketing start
2015-04-07
Marketing end
0000-00-00
Substance
LISINOPRIL
Active strength
3 mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52427-438DDiscontinued by firm2026-08-17
excluded packagepackage52427-43852427-438-90DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52427-438-90d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52427-438-90f5e01cc5f278…a2eaf40c39c3…

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
N019777-001ZESTRILLISINOPRIL5MGTABLET / ORALABRLD1988-05-19
N019777-002ZESTRILLISINOPRIL10MGTABLET / ORALABRLD1988-05-19
N019777-003ZESTRILLISINOPRIL20MGTABLET / ORALABRLD1988-05-19
N019777-004ZESTRILLISINOPRIL40MGTABLET / ORALABRLD, RS1988-05-19
N019777-005ZESTRILLISINOPRIL2.5MGTABLET / ORALABRLD1993-04-29
N019777-006ZESTRILLISINOPRIL30MGTABLET / ORALABRLD1999-01-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N019777-001AB
N019777-002AB
N019777-003AB
N019777-004AB
N019777-005AB
N019777-006AB

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 06:07:402026-07N019777-001ZESTRIL5MGTABLET / ORALABRLD1988-05-19caaa826d4ba7…
2026-08-18 06:07:402026-07N019777-002ZESTRIL10MGTABLET / ORALABRLD1988-05-19caaa826d4ba7…
2026-08-18 06:07:402026-07N019777-003ZESTRIL20MGTABLET / ORALABRLD1988-05-19caaa826d4ba7…
2026-08-18 06:07:402026-07N019777-004ZESTRIL40MGTABLET / ORALABRLD, RS1988-05-19caaa826d4ba7…
2026-08-18 06:07:402026-07N019777-005ZESTRIL2.5MGTABLET / ORALABRLD1993-04-29caaa826d4ba7…
2026-08-18 06:07:402026-07N019777-006ZESTRIL30MGTABLET / ORALABRLD1999-01-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019777-001ZESTRIL5MGTABLET / ORALABRLD1988-05-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019777-002ZESTRIL10MGTABLET / ORALABRLD1988-05-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019777-003ZESTRIL20MGTABLET / ORALABRLD1988-05-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019777-004ZESTRIL40MGTABLET / ORALABRLD, RS1988-05-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019777-005ZESTRIL2.5MGTABLET / ORALABRLD1993-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019777-006ZESTRIL30MGTABLET / ORALABRLD1999-01-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019777-001ZESTRIL5MGTABLET / ORALABRLD1988-05-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019777-002ZESTRIL10MGTABLET / ORALABRLD1988-05-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019777-003ZESTRIL20MGTABLET / ORALABRLD1988-05-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019777-004ZESTRIL40MGTABLET / ORALABRLD, RS1988-05-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019777-005ZESTRIL2.5MGTABLET / ORALABRLD1993-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019777-006ZESTRIL30MGTABLET / ORALABRLD1999-01-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08N019777-001ZESTRIL5MGTABLET / ORALABRLD1988-05-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019777-002ZESTRIL10MGTABLET / ORALABRLD1988-05-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019777-003ZESTRIL20MGTABLET / ORALABRLD1988-05-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019777-004ZESTRIL40MGTABLET / ORALABRLD, RS1988-05-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019777-005ZESTRIL2.5MGTABLET / ORALABRLD1993-04-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019777-006ZESTRIL30MGTABLET / ORALABRLD1999-01-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019777-001ZESTRIL5MGTABLET / ORALABRLD1988-05-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019777-002ZESTRIL10MGTABLET / ORALABRLD1988-05-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019777-003ZESTRIL20MGTABLET / ORALABRLD1988-05-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019777-004ZESTRIL40MGTABLET / ORALABRLD, RS1988-05-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019777-005ZESTRIL2.5MGTABLET / ORALABRLD1993-04-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019777-006ZESTRIL30MGTABLET / ORALABRLD1999-01-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019777-001ZESTRIL5MGTABLET / ORALABRLD1988-05-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019777-002ZESTRIL10MGTABLET / ORALABRLD1988-05-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019777-003ZESTRIL20MGTABLET / ORALABRLD1988-05-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019777-004ZESTRIL40MGTABLET / ORALABRLD, RS1988-05-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019777-005ZESTRIL2.5MGTABLET / ORALABRLD1993-04-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019777-006ZESTRIL30MGTABLET / ORALABRLD1999-01-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019777-001ZESTRIL5MGTABLET / ORALABRLD1988-05-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019777-002ZESTRIL10MGTABLET / ORALABRLD1988-05-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019777-003ZESTRIL20MGTABLET / ORALABRLD1988-05-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019777-004ZESTRIL40MGTABLET / ORALABRLD, RS1988-05-1903ed91905a0d…

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 06:07:402026-07N019777-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N019777-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N019777-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N019777-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N019777-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N019777-006AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019777-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019777-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019777-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019777-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019777-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019777-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019777-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019777-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019777-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019777-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019777-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019777-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019777-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019777-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019777-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019777-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019777-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019777-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019777-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019777-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019777-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019777-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019777-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019777-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019777-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019777-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019777-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019777-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019777-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019777-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019777-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019777-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019777-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019777-004AB103ed91905a0d…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52427-438-90EA - Each52427-4388ddf0657-a8f4-4931-97a8-f06c5db5e89c12015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LISINOPRILACTIVE INGREDIENTE7199S1YWRZESTRIL (LISINOPRIL) TABLET [ALMATICA PHARMA INC.]6
LISINOPRIL ANHYDROUSACTIVE MOIETY7Q3P4BS2FDZESTRIL (LISINOPRIL) TABLET [ALMATICA PHARMA INC.]6
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPZESTRIL (LISINOPRIL) TABLET [ALMATICA PHARMA INC.]6
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZESTRIL (LISINOPRIL) TABLET [ALMATICA PHARMA INC.]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTZESTRIL (LISINOPRIL) TABLET [ALMATICA PHARMA INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZESTRIL (LISINOPRIL) TABLET [ALMATICA PHARMA INC.]6
MANNITOLINACTIVE INGREDIENT3OWL53L36AZESTRIL (LISINOPRIL) TABLET [ALMATICA PHARMA INC.]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJZESTRIL (LISINOPRIL) TABLET [ALMATICA PHARMA INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52427-438ZESTRIL (LISINOPRIL) TABLET [ALMATICA PHARMA LLC]16Legacy NDC20241122_a95727ae-2bf1-e675-4a36-71043a8af3b8.zip

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZestrilLISINOPRILUpsher-Smith Laboratories, LLC838c2d78-d2d8-4981-9ec9-e50ef9e1a5d82025-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 019777
application number: NDA019777

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52427-438-905242704389090 TABLET in 1 BOTTLE (52427-438-90) 90 tablet2017-07-210000-00-00NoNoCurrent