Lisinopril

Product NDC
63187-237
11-digit product format
631870237
Labeler code
63187
Product ID
63187-237_f0c279c5-1f67-4d03-ba2d-6202d619299c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077321
Marketing category
ANDA
Marketing start
2006-01-13
Substance
LISINOPRIL
Active strength
40 mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
A077321-001LISINOPRILLISINOPRIL2.5MGTABLET / ORALAB2005-09-09
A077321-002LISINOPRILLISINOPRIL5MGTABLET / ORALAB2005-09-09
A077321-003LISINOPRILLISINOPRIL10MGTABLET / ORALAB2005-09-09
A077321-004LISINOPRILLISINOPRIL20MGTABLET / ORALAB2005-09-09
A077321-005LISINOPRILLISINOPRIL30MGTABLET / ORALAB2005-09-09
A077321-006LISINOPRILLISINOPRIL40MGTABLET / ORALAB2005-09-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077321-001AB
A077321-002AB
A077321-003AB
A077321-004AB
A077321-005AB
A077321-006AB

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 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077321-001LISINOPRIL2.5MGTABLET / ORALAB2005-09-0984e616aacf4f…
2026-09-14 22:38:342026-08A077321-002LISINOPRIL5MGTABLET / ORALAB2005-09-0984e616aacf4f…
2026-09-14 22:38:342026-08A077321-003LISINOPRIL10MGTABLET / ORALAB2005-09-0984e616aacf4f…
2026-09-14 22:38:342026-08A077321-004LISINOPRIL20MGTABLET / ORALAB2005-09-0984e616aacf4f…
2026-09-14 22:38:342026-08A077321-005LISINOPRIL30MGTABLET / ORALAB2005-09-0984e616aacf4f…
2026-09-14 22:38:342026-08A077321-006LISINOPRIL40MGTABLET / ORALAB2005-09-0984e616aacf4f…
2026-08-18 06:07:402026-07A077321-001LISINOPRIL2.5MGTABLET / ORALAB2005-09-09caaa826d4ba7…
2026-08-18 06:07:402026-07A077321-002LISINOPRIL5MGTABLET / ORALAB2005-09-09caaa826d4ba7…
2026-08-18 06:07:402026-07A077321-003LISINOPRIL10MGTABLET / ORALAB2005-09-09caaa826d4ba7…
2026-08-18 06:07:402026-07A077321-004LISINOPRIL20MGTABLET / ORALAB2005-09-09caaa826d4ba7…
2026-08-18 06:07:402026-07A077321-005LISINOPRIL30MGTABLET / ORALAB2005-09-09caaa826d4ba7…
2026-08-18 06:07:402026-07A077321-006LISINOPRIL40MGTABLET / ORALAB2005-09-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077321-001LISINOPRIL2.5MGTABLET / ORALAB2005-09-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077321-002LISINOPRIL5MGTABLET / ORALAB2005-09-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077321-003LISINOPRIL10MGTABLET / ORALAB2005-09-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077321-004LISINOPRIL20MGTABLET / ORALAB2005-09-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077321-005LISINOPRIL30MGTABLET / ORALAB2005-09-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077321-006LISINOPRIL40MGTABLET / ORALAB2005-09-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077321-001LISINOPRIL2.5MGTABLET / ORALAB2005-09-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077321-002LISINOPRIL5MGTABLET / ORALAB2005-09-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077321-003LISINOPRIL10MGTABLET / ORALAB2005-09-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077321-004LISINOPRIL20MGTABLET / ORALAB2005-09-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077321-005LISINOPRIL30MGTABLET / ORALAB2005-09-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077321-006LISINOPRIL40MGTABLET / ORALAB2005-09-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A077321-001LISINOPRIL2.5MGTABLET / ORALAB2005-09-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077321-002LISINOPRIL5MGTABLET / ORALAB2005-09-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077321-003LISINOPRIL10MGTABLET / ORALAB2005-09-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077321-004LISINOPRIL20MGTABLET / ORALAB2005-09-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077321-005LISINOPRIL30MGTABLET / ORALAB2005-09-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077321-006LISINOPRIL40MGTABLET / ORALAB2005-09-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077321-001LISINOPRIL2.5MGTABLET / ORALAB2005-09-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077321-002LISINOPRIL5MGTABLET / ORALAB2005-09-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077321-003LISINOPRIL10MGTABLET / ORALAB2005-09-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077321-004LISINOPRIL20MGTABLET / ORALAB2005-09-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077321-005LISINOPRIL30MGTABLET / ORALAB2005-09-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077321-006LISINOPRIL40MGTABLET / ORALAB2005-09-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077321-001LISINOPRIL2.5MGTABLET / ORALAB2005-09-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077321-002LISINOPRIL5MGTABLET / ORALAB2005-09-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077321-003LISINOPRIL10MGTABLET / ORALAB2005-09-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077321-004LISINOPRIL20MGTABLET / ORALAB2005-09-09b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A077321-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A077321-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A077321-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A077321-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A077321-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A077321-006AB184e616aacf4f…
2026-08-18 06:07:402026-07A077321-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077321-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077321-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077321-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077321-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077321-006AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077321-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077321-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077321-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077321-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077321-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077321-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077321-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077321-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077321-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077321-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077321-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077321-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077321-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077321-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077321-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077321-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077321-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077321-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077321-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077321-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077321-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077321-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077321-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077321-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077321-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077321-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077321-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077321-004AB1b8a1b40f171c…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Lisinopril
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LISINOPRIL40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
E7199S1YWRInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197884Internal RxNorm lookup
314076Internal RxNorm lookup
314077Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d87620e1-1a43-43a2-ab37-b9111ea5c17eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f8f05a6d-f74b-4e9e-ab1c-374d3b4fb820Product name120230703
f65307a7-3644-0a09-cdfd-94aae8d3b53eProduct name320210902
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-237-30Lisinopril30 in 1 BOTTLETABLET306
63187-237-60Lisinopril60 in 1 BOTTLETABLET606
63187-237-90Lisinopril90 in 1 BOTTLETABLET906

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LISINOPRILACTIVE INGREDIENTE7199S1YWRLISINOPRIL TABLET [PROFICIENT RX LP]3
LISINOPRIL ANHYDROUSACTIVE MOIETY7Q3P4BS2FDLISINOPRIL TABLET [PROFICIENT RX LP]3
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JLISINOPRIL TABLET [PROFICIENT RX LP]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LISINOPRIL TABLET [PROFICIENT RX LP]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LISINOPRIL TABLET [PROFICIENT RX LP]3
MANNITOLINACTIVE INGREDIENT3OWL53L36ALISINOPRIL TABLET [PROFICIENT RX LP]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LISINOPRIL TABLET [PROFICIENT RX LP]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLISINOPRIL TABLET [PROFICIENT RX LP]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-237LISINOPRIL TABLET [PROFICIENT RX LP]6Current NDC, Legacy NDC, 3 package rows20191121_d87620e1-1a43-43a2-ab37-b9111ea5c17e.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 3 · 57 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LisinoprilLISINOPRILREMEDYREPACK INC.aa5d68e7-c2b9-41eb-ade4-2cd57edc15332026-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077321
application number: ANDA077321
LisinoprilLISINOPRILREMEDYREPACK INC.463308ef-16cb-41d8-8d29-6aae2c5a7b0f2026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077321
application number: ANDA077321
LisinoprilLISINOPRILREMEDYREPACK INC.34bb4602-ccff-4939-91b9-26a63bfd40f72026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077321
application number: ANDA077321
LisinoprilLISINOPRILREMEDYREPACK INC.a33d860a-1e17-45b7-aede-51ab3223bebd2026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077321
application number: ANDA077321
LisinoprilLISINOPRILA-S Medication Solutions88b5a2c0-6ad2-48e7-9ffe-715d9159f3892026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077321
application number: ANDA077321
LisinoprilLISINOPRILA-S Medication Solutions34953f77-bae1-41fe-af11-3ea0b3ceaa112026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077321
application number: ANDA077321
LisinoprilLISINOPRILREMEDYREPACK INC.3451292b-7867-4dc2-afaa-da66b40160172026-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077321
application number: ANDA077321
LisinoprilLISINOPRILREMEDYREPACK INC.d32923fe-a323-43c6-af46-bcba7274b0bf2026-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077321
application number: ANDA077321
LisinoprilLISINOPRILUnit Dose Solutions, Inc.551665a0-9a92-55df-e063-6394a90a1e2e2026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077321
application number: ANDA077321
LisinoprilLISINOPRILUnit Dose Solutions, Inc.55189717-f5db-9c63-e063-6294a90a6bc92026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077321
application number: ANDA077321
LisinoprilLISINOPRILUnit Dose Solutions, Inc.55191baa-f812-2e71-e063-6294a90a8edf2026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077321
application number: ANDA077321
LisinoprilLISINOPRILPD-Rx Pharmaceuticals, Inc.c621c33b-cb67-4ea6-b2bd-96c20a244ea42026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077321
application number: ANDA077321
LisinoprilLISINOPRILCoupler LLC538429b8-4f10-e825-e063-6294a90a59052026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077321
application number: ANDA077321
LisinoprilLISINOPRILCardinal Health 107, LLC1d0caa63-9ea2-4a97-a23b-900a7c514bc62026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077321
application number: ANDA077321
LisinoprilLISINOPRILCoupler LLC518a63e3-8ca1-bbd1-e063-6294a90aa5242026-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077321
application number: ANDA077321
LisinoprilLISINOPRILCoupler LLC509a46cf-7a89-b6c0-e063-6394a90a75092026-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077321
application number: ANDA077321
LisinoprilLISINOPRILBryant Ranch Prepack08b0555e-41d2-44c3-b27b-ad5d701378dc2026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077321
application number: ANDA077321
LisinoprilLISINOPRILBryant Ranch Prepack59fd2167-4da4-9143-83bd-3b6aa50515112026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077321
application number: ANDA077321
LisinoprilLISINOPRILREMEDYREPACK INC.a35079fa-b693-45e8-9715-488e33e7c1a92026-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077321
application number: ANDA077321
LisinoprilLISINOPRILREMEDYREPACK INC.f22bfb4d-dda6-4c7f-a485-cfb7710ef3de2026-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077321
application number: ANDA077321

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314076lisinopril 10 MG Oral TabletPSNd87620e1-1a43-43a2-ab37-b9111ea5c17e6
314077lisinopril 20 MG Oral TabletPSNd87620e1-1a43-43a2-ab37-b9111ea5c17e6
197884lisinopril 40 MG Oral TabletPSNd87620e1-1a43-43a2-ab37-b9111ea5c17e6
314076lisinopril 10 MG Oral TabletSCDd87620e1-1a43-43a2-ab37-b9111ea5c17e6
314077lisinopril 20 MG Oral TabletSCDd87620e1-1a43-43a2-ab37-b9111ea5c17e6
197884lisinopril 40 MG Oral TabletSCDd87620e1-1a43-43a2-ab37-b9111ea5c17e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-237-306318702373030 TABLET in 1 BOTTLE (63187-237-30) 30 tablet2014-11-030000-00-00NoNoCurrent
63187-237-606318702376060 TABLET in 1 BOTTLE (63187-237-60) 60 tablet2014-11-030000-00-00NoNoCurrent
63187-237-906318702379090 TABLET in 1 BOTTLE (63187-237-90) 90 tablet2014-11-030000-00-00NoNoCurrent