LISINOPRIL

Product NDC
76282-730
11-digit product format
762820730
Labeler code
76282
Product ID
76282-730_c3c02066-1571-4291-ae9a-fd50a43486ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LISINOPRIL
Dosage form
TABLET
Route
ORAL
Labeler
Exelan Pharmaceuticals, Inc
Application
ANDA076102
Marketing category
ANDA
Marketing start
2023-04-07
Substance
LISINOPRIL
Active strength
10 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
A076102-001LISINOPRILLISINOPRIL2.5MGTABLET / ORALAB2002-09-30
A076102-002LISINOPRILLISINOPRIL5MGTABLET / ORALAB2002-09-30
A076102-003LISINOPRILLISINOPRIL10MGTABLET / ORALAB2002-09-30
A076102-004LISINOPRILLISINOPRIL20MGTABLET / ORALAB2002-09-30
A076102-005LISINOPRILLISINOPRIL30MGTABLET / ORALAB2002-09-30
A076102-006LISINOPRILLISINOPRIL40MGTABLET / ORALAB2002-09-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076102-001AB
A076102-002AB
A076102-003AB
A076102-004AB
A076102-005AB
A076102-006AB

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 22:38:342026-08A076102-001LISINOPRIL2.5MGTABLET / ORALAB2002-09-3084e616aacf4f…
2026-09-14 22:38:342026-08A076102-002LISINOPRIL5MGTABLET / ORALAB2002-09-3084e616aacf4f…
2026-09-14 22:38:342026-08A076102-003LISINOPRIL10MGTABLET / ORALAB2002-09-3084e616aacf4f…
2026-09-14 22:38:342026-08A076102-004LISINOPRIL20MGTABLET / ORALAB2002-09-3084e616aacf4f…
2026-09-14 22:38:342026-08A076102-005LISINOPRIL30MGTABLET / ORALAB2002-09-3084e616aacf4f…
2026-09-14 22:38:342026-08A076102-006LISINOPRIL40MGTABLET / ORALAB2002-09-3084e616aacf4f…
2026-08-18 06:07:402026-07A076102-001LISINOPRIL2.5MGTABLET / ORALAB2002-09-30caaa826d4ba7…
2026-08-18 06:07:402026-07A076102-002LISINOPRIL5MGTABLET / ORALAB2002-09-30caaa826d4ba7…
2026-08-18 06:07:402026-07A076102-003LISINOPRIL10MGTABLET / ORALAB2002-09-30caaa826d4ba7…
2026-08-18 06:07:402026-07A076102-004LISINOPRIL20MGTABLET / ORALAB2002-09-30caaa826d4ba7…
2026-08-18 06:07:402026-07A076102-005LISINOPRIL30MGTABLET / ORALAB2002-09-30caaa826d4ba7…
2026-08-18 06:07:402026-07A076102-006LISINOPRIL40MGTABLET / ORALAB2002-09-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076102-001LISINOPRIL2.5MGTABLET / ORALAB2002-09-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076102-002LISINOPRIL5MGTABLET / ORALAB2002-09-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076102-003LISINOPRIL10MGTABLET / ORALAB2002-09-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076102-004LISINOPRIL20MGTABLET / ORALAB2002-09-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076102-005LISINOPRIL30MGTABLET / ORALAB2002-09-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076102-006LISINOPRIL40MGTABLET / ORALAB2002-09-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076102-001LISINOPRIL2.5MGTABLET / ORALAB2002-09-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076102-002LISINOPRIL5MGTABLET / ORALAB2002-09-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076102-003LISINOPRIL10MGTABLET / ORALAB2002-09-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076102-004LISINOPRIL20MGTABLET / ORALAB2002-09-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076102-005LISINOPRIL30MGTABLET / ORALAB2002-09-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076102-006LISINOPRIL40MGTABLET / ORALAB2002-09-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A076102-001LISINOPRIL2.5MGTABLET / ORALAB2002-09-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076102-002LISINOPRIL5MGTABLET / ORALAB2002-09-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076102-003LISINOPRIL10MGTABLET / ORALAB2002-09-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076102-004LISINOPRIL20MGTABLET / ORALAB2002-09-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076102-005LISINOPRIL30MGTABLET / ORALAB2002-09-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076102-006LISINOPRIL40MGTABLET / ORALAB2002-09-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076102-001LISINOPRIL2.5MGTABLET / ORALAB2002-09-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076102-002LISINOPRIL5MGTABLET / ORALAB2002-09-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076102-003LISINOPRIL10MGTABLET / ORALAB2002-09-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076102-004LISINOPRIL20MGTABLET / ORALAB2002-09-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076102-005LISINOPRIL30MGTABLET / ORALAB2002-09-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076102-006LISINOPRIL40MGTABLET / ORALAB2002-09-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076102-001LISINOPRIL2.5MGTABLET / ORALAB2002-09-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076102-002LISINOPRIL5MGTABLET / ORALAB2002-09-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076102-003LISINOPRIL10MGTABLET / ORALAB2002-09-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076102-004LISINOPRIL20MGTABLET / ORALAB2002-09-30b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 7 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076102-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076102-004AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076102-005AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076102-006AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076102-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076102-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076102-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076102-004AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076102-005AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076102-006AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076102-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076102-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076102-003AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076102-004AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076102-005AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076102-006AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076102-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076102-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076102-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076102-004AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076102-005AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076102-006AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076102-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076102-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076102-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076102-004AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076102-005AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076102-006AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076102-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076102-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076102-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076102-004AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076102-005AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076102-006AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076102-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076102-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076102-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076102-004AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076102-005AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076102-006AB174a2ff9319b5…

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
LISINOPRIL10 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 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197884Internal RxNorm lookup
205326Internal RxNorm lookup
311353Internal RxNorm lookup
311354Internal 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
4aad4d30-3e18-489c-80ad-ccf7532bb933Available 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
76282-730-01LISINOPRIL100 in 1 BOTTLETABLET1008
76282-730-05LISINOPRIL500 in 1 BOTTLETABLET5008
76282-730-10LISINOPRIL1000 in 1 BOTTLETABLET10008
76282-730-18LISINOPRIL180 in 1 BOTTLETABLET1808
76282-730-30LISINOPRIL30 in 1 BOTTLETABLET308
76282-730-45LISINOPRIL45 in 1 BOTTLETABLET458
76282-730-50LISINOPRIL5000 in 1 BOTTLETABLET50008
76282-730-90LISINOPRIL90 in 1 BOTTLETABLET908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-730-01EA - Each76282-7309bc1d798-e5c8-4b46-9b19-02592eccd0fb12023-07-06
76282-730-10EA - Each76282-7302632d4db-af8b-45ff-bdd5-d3dc2c67ea4312023-07-06
76282-730-45EA - Each76282-730a4d593b1-6cec-4caa-b83b-32e4430a44cc12023-07-06
76282-730-50EA - Each76282-730b074464b-7636-4710-9154-4d791c90e93812024-09-09
76282-730-90EA - Each76282-730fc8387f2-37d3-43d0-8662-47aa619aa73712023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-730LISINOPRIL TABLET [EXELAN PHARMACEUTICALS, INC]8Current NDC, 8 package rows20240504_4aad4d30-3e18-489c-80ad-ccf7532bb933.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
lisinoprilLISINOPRILBryant Ranch Prepackd8a0c806-8f5e-41c0-91c6-ad267af27a532026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076102
application number: ANDA076102
LISINOPRILLISINOPRILAphena Pharma Solutions - Tennessee, LLC3a3d4f6c-9f68-44e4-8cf8-32742e3b50212025-12-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076102
application number: ANDA076102
LISINOPRILLISINOPRILExelan Pharmaceuticals, Inc4aad4d30-3e18-489c-80ad-ccf7532bb9332024-05-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076102
application number: ANDA076102
ndc (product): 76282-730
LISINOPRILLISINOPRILAphena Pharma Solutions - Tennessee, LLCaeee8e9a-333a-416e-ab69-a0d40e1468832024-01-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076102
application number: ANDA076102
LISINOPRILLISINOPRILAphena Pharma Solutions - Tennessee, LLCa32db461-4f77-46ef-b49b-250711dade172023-12-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076102
application number: ANDA076102
LISINOPRILLISINOPRILAphena Pharma Solutions - Tennessee, LLC719c4db7-ccbe-4779-baa7-a3c461f3aa522023-09-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076102
application number: ANDA076102
lisinoprilLISINOPRILHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.(780779901)c6c55efa-36bd-4613-98ca-2eb589a31e532023-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076102
application number: ANDA076102

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314076lisinopril 10 MG Oral TabletPSN4aad4d30-3e18-489c-80ad-ccf7532bb9338
311353lisinopril 2.5 MG Oral TabletPSN4aad4d30-3e18-489c-80ad-ccf7532bb9338
314077lisinopril 20 MG Oral TabletPSN4aad4d30-3e18-489c-80ad-ccf7532bb9338
205326lisinopril 30 MG Oral TabletPSN4aad4d30-3e18-489c-80ad-ccf7532bb9338
197884lisinopril 40 MG Oral TabletPSN4aad4d30-3e18-489c-80ad-ccf7532bb9338
311354lisinopril 5 MG Oral TabletPSN4aad4d30-3e18-489c-80ad-ccf7532bb9338
314076lisinopril 10 MG Oral TabletSCD4aad4d30-3e18-489c-80ad-ccf7532bb9338
311353lisinopril 2.5 MG Oral TabletSCD4aad4d30-3e18-489c-80ad-ccf7532bb9338
314077lisinopril 20 MG Oral TabletSCD4aad4d30-3e18-489c-80ad-ccf7532bb9338
205326lisinopril 30 MG Oral TabletSCD4aad4d30-3e18-489c-80ad-ccf7532bb9338
197884lisinopril 40 MG Oral TabletSCD4aad4d30-3e18-489c-80ad-ccf7532bb9338
311354lisinopril 5 MG Oral TabletSCD4aad4d30-3e18-489c-80ad-ccf7532bb9338
314076lisinopril 10 MG Oral TabletPSN3a3d4f6c-9f68-44e4-8cf8-32742e3b50214
197884lisinopril 40 MG Oral TabletPSN3a3d4f6c-9f68-44e4-8cf8-32742e3b50214
314076lisinopril 10 MG Oral TabletSCD3a3d4f6c-9f68-44e4-8cf8-32742e3b50214
197884lisinopril 40 MG Oral TabletSCD3a3d4f6c-9f68-44e4-8cf8-32742e3b50214

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76282-730-0176282073001100 TABLET in 1 BOTTLE (76282-730-01) 100 tablet2023-04-07NoNoCurrent
76282-730-0576282073005500 TABLET in 1 BOTTLE (76282-730-05) 500 tablet2023-04-07NoNoCurrent
76282-730-10762820730101000 TABLET in 1 BOTTLE (76282-730-10) 1000 tablet2023-04-07NoNoCurrent
76282-730-1876282073018180 TABLET in 1 BOTTLE (76282-730-18) 180 tablet2023-04-07NoNoCurrent
76282-730-307628207303030 TABLET in 1 BOTTLE (76282-730-30) 30 tablet2023-04-07NoNoCurrent
76282-730-457628207304545 TABLET in 1 BOTTLE (76282-730-45) 45 tablet2023-04-07NoNoCurrent
76282-730-50762820730505000 TABLET in 1 BOTTLE (76282-730-50) 5000 tablet2024-05-01NoNoCurrent
76282-730-907628207309090 TABLET in 1 BOTTLE (76282-730-90) 90 tablet2023-04-07NoNoCurrent