LISINOPRIL

Product NDC
70518-1565
Requested package NDC
70518-1565-2
11-digit product format
705181565
Labeler code
70518
Product ID
70518-1565_561ce248-ff4d-cc5d-e063-6394a90a528d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA076164
Marketing category
ANDA
Marketing start
2018-10-22
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

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 · 10 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
A076164-001LISINOPRILLISINOPRIL20MGTABLET / ORALAB2002-07-01
A076164-002LISINOPRILLISINOPRIL30MGTABLET / ORALAB2002-07-01
A076164-003LISINOPRILLISINOPRIL40MGTABLET / ORALAB2002-07-01
A076164-004LISINOPRILLISINOPRIL2.5MGTABLET / ORALAB2002-07-01
A076164-005LISINOPRILLISINOPRIL5MGTABLET / ORALAB2002-07-01
A076164-006LISINOPRILLISINOPRIL10MGTABLET / 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
A076164-001AB
A076164-002AB
A076164-003AB
A076164-004AB
A076164-005AB
A076164-006AB

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 · 243 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076164-001LISINOPRIL20MGTABLET / ORALAB2002-07-0184e616aacf4f…
2026-09-14 22:38:342026-08A076164-002LISINOPRIL30MGTABLET / ORALAB2002-07-0184e616aacf4f…
2026-09-14 22:38:342026-08A076164-003LISINOPRIL40MGTABLET / ORALAB2002-07-0184e616aacf4f…
2026-09-14 22:38:342026-08A076164-004LISINOPRIL2.5MGTABLET / ORALAB2002-07-0184e616aacf4f…
2026-09-14 22:38:342026-08A076164-005LISINOPRIL5MGTABLET / ORALAB2002-07-0184e616aacf4f…
2026-09-14 22:38:342026-08A076164-006LISINOPRIL10MGTABLET / ORALAB2002-07-0184e616aacf4f…
2026-08-18 06:07:402026-07A076164-001LISINOPRIL20MGTABLET / ORALAB2002-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A076164-002LISINOPRIL30MGTABLET / ORALAB2002-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A076164-003LISINOPRIL40MGTABLET / ORALAB2002-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A076164-004LISINOPRIL2.5MGTABLET / ORALAB2002-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A076164-005LISINOPRIL5MGTABLET / ORALAB2002-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A076164-006LISINOPRIL10MGTABLET / ORALAB2002-07-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076164-001LISINOPRIL20MGTABLET / ORALAB2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076164-002LISINOPRIL30MGTABLET / ORALAB2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076164-003LISINOPRIL40MGTABLET / ORALAB2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076164-004LISINOPRIL2.5MGTABLET / ORALAB2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076164-005LISINOPRIL5MGTABLET / ORALAB2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076164-006LISINOPRIL10MGTABLET / ORALAB2002-07-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076164-001LISINOPRIL20MGTABLET / ORALAB2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076164-002LISINOPRIL30MGTABLET / ORALAB2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076164-003LISINOPRIL40MGTABLET / ORALAB2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076164-004LISINOPRIL2.5MGTABLET / ORALAB2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076164-005LISINOPRIL5MGTABLET / ORALAB2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076164-006LISINOPRIL10MGTABLET / ORALAB2002-07-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076164-001LISINOPRIL20MGTABLET / ORALAB2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076164-002LISINOPRIL30MGTABLET / ORALAB2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076164-003LISINOPRIL40MGTABLET / ORALAB2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076164-004LISINOPRIL2.5MGTABLET / ORALAB2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076164-005LISINOPRIL5MGTABLET / ORALAB2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076164-006LISINOPRIL10MGTABLET / ORALAB2002-07-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076164-001LISINOPRIL20MGTABLET / ORALAB2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076164-002LISINOPRIL30MGTABLET / ORALAB2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076164-003LISINOPRIL40MGTABLET / ORALAB2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076164-004LISINOPRIL2.5MGTABLET / ORALAB2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076164-005LISINOPRIL5MGTABLET / ORALAB2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076164-006LISINOPRIL10MGTABLET / ORALAB2002-07-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076164-001LISINOPRIL20MGTABLET / ORALAB2002-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076164-002LISINOPRIL30MGTABLET / ORALAB2002-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076164-003LISINOPRIL40MGTABLET / ORALAB2002-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076164-004LISINOPRIL2.5MGTABLET / ORALAB2002-07-01b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 243 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A076164-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A076164-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A076164-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A076164-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A076164-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A076164-006AB184e616aacf4f…
2026-08-18 06:07:402026-07A076164-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076164-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076164-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076164-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076164-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076164-006AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076164-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076164-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076164-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076164-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076164-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076164-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076164-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076164-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076164-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076164-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076164-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076164-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076164-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076164-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076164-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076164-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076164-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076164-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076164-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076164-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076164-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076164-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076164-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076164-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076164-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076164-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076164-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076164-004AB1b8a1b40f171c…

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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
12d6fe7e-b5a2-4d49-9a06-a6150234d061Available 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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-1565-0LISINOPRIL90 in 1 BOTTLE, PLASTICTABLET9011
70518-1565-1LISINOPRIL30 in 1 BLISTER PACKTABLET3011
70518-1565-2LISINOPRIL100 in 1 BOTTLE, PLASTICTABLET10011
70518-1565-3LISINOPRIL30 in 1 BOTTLE, PLASTICTABLET3011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1565LISINOPRIL TABLET [REMEDYREPACK INC.]9Current NDC, Legacy NDC, 4 package rows20250424_12d6fe7e-b5a2-4d49-9a06-a6150234d061.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 · 50 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LISINOPRILLISINOPRILREMEDYREPACK INC.12d6fe7e-b5a2-4d49-9a06-a6150234d0612026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076164
application number: ANDA076164
ndc (package): 70518-1565-2
ndc (product): 70518-1565
ndc11 (package): 70518156502
LISINOPRILLISINOPRILCoupler LLC560513ef-4d2c-8ca0-e063-6394a90a674a2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076164
application number: ANDA076164
LISINOPRILLISINOPRILREMEDYREPACK INC.e17bcc2e-f5ed-4846-95d3-a5479c7fee8d2026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076164
application number: ANDA076164
LISINOPRILLISINOPRILSt. Mary's Medical Park Pharmacy5f4c1a62-fb84-8cdc-e053-2a91aa0a671a2026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076164
application number: ANDA076164
LISINOPRILLISINOPRILSt. Mary's Medical Park Pharmacy5eff766f-82e2-4cd6-e053-2a91aa0a47822026-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076164
application number: ANDA076164
LISINOPRILLISINOPRILNuCare Pharmaceuticals, Inc.4b6dc0d4-4acd-3606-e054-00144ff8d46c2026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076164
application number: ANDA076164
LISINOPRILLISINOPRILPreferred Pharmaceuticals Inc.ab561d21-7466-4d8b-8d06-291c1d4d82ff2026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076164
application number: ANDA076164
LISINOPRILLISINOPRILPreferred Pharmaceuticals Inc.02c23f9c-f3cf-4366-ae1e-56296f1fedf92026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076164
application number: ANDA076164
LISINOPRILLISINOPRILA-S Medication Solutionsf57bd658-05d8-475a-ae74-87d2c78664172026-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076164
application number: ANDA076164
LISINOPRILLISINOPRILA-S Medication Solutions176c744a-d4e3-4a4b-ac62-4fbcb1d8d7bf2026-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076164
application number: ANDA076164
LISINOPRILLISINOPRILA-S Medication Solutionsbd804d65-742a-4890-ac9d-bee69968387d2026-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076164
application number: ANDA076164
LISINOPRILLISINOPRILA-S Medication Solutions11a83bbc-9871-4df8-b3f2-7aba5149f3fe2026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076164
application number: ANDA076164
LISINOPRILLISINOPRILProficient Rx LPeddec313-910c-4bf1-9095-2153db53bc6e2026-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076164
application number: ANDA076164
LISINOPRILLISINOPRILProficient Rx LP350c6fc9-9774-4d49-9242-19e96944f83b2026-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076164
application number: ANDA076164
LISINOPRILLISINOPRILA-S Medication Solutionsd18f2117-0d2a-4e0d-8ffb-130ca69003642026-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076164
application number: ANDA076164
LISINOPRILLISINOPRILRedPharm Drug, Inc.4f08cfc9-7afc-33aa-e054-00144ff88e882026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076164
application number: ANDA076164
LISINOPRILLISINOPRILNorthwind Health Company, LLCab2f8ab5-3c87-484a-e053-2995a90a42bb2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076164
application number: ANDA076164
LISINOPRILLISINOPRILNorthwind Health Company, LLCae2cdf9b-e71e-8315-e053-2995a90a53102026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076164
application number: ANDA076164
LISINOPRILLISINOPRILNorthwind Health Company, LLCdac0c8f1-e3cf-11e6-e053-2a95a90adbcb2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076164
application number: ANDA076164
LISINOPRILLISINOPRILNorthwind Health Company, LLCae2d9df4-29ce-3d07-e053-2995a90ab1842026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076164
application number: ANDA076164

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197884lisinopril 40 MG Oral TabletPSN12d6fe7e-b5a2-4d49-9a06-a6150234d06111
197884lisinopril 40 MG Oral TabletSCD12d6fe7e-b5a2-4d49-9a06-a6150234d06111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-1565-270518156502100 TABLET in 1 BOTTLE, PLASTIC (70518-1565-2) 100 tablet2018-10-26NoNoCurrent