Lisinopril

Product NDC
65862-038
Requested package NDC
65862-038-05
11-digit product format
658620038
Labeler code
65862
Product ID
65862-038_99502ee9-cea6-473a-91c1-e4b4ded719e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA077622
Marketing category
ANDA
Marketing start
2006-02-22
Substance
LISINOPRIL
Active strength
5 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
A077622-001LISINOPRILLISINOPRIL2.5MGTABLET / ORALAB2006-02-22
A077622-002LISINOPRILLISINOPRIL5MGTABLET / ORALAB2006-02-22
A077622-003LISINOPRILLISINOPRIL10MGTABLET / ORALAB2006-02-22
A077622-004LISINOPRILLISINOPRIL20MGTABLET / ORALAB2006-02-22
A077622-005LISINOPRILLISINOPRIL30MGTABLET / ORALAB2006-02-22
A077622-006LISINOPRILLISINOPRIL40MGTABLET / ORALAB2006-02-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077622-001AB
A077622-002AB
A077622-003AB
A077622-004AB
A077622-005AB
A077622-006AB

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 22:38:342026-08A077622-001LISINOPRIL2.5MGTABLET / ORALAB2006-02-2284e616aacf4f…
2026-09-14 22:38:342026-08A077622-002LISINOPRIL5MGTABLET / ORALAB2006-02-2284e616aacf4f…
2026-09-14 22:38:342026-08A077622-003LISINOPRIL10MGTABLET / ORALAB2006-02-2284e616aacf4f…
2026-09-14 22:38:342026-08A077622-004LISINOPRIL20MGTABLET / ORALAB2006-02-2284e616aacf4f…
2026-09-14 22:38:342026-08A077622-005LISINOPRIL30MGTABLET / ORALAB2006-02-2284e616aacf4f…
2026-09-14 22:38:342026-08A077622-006LISINOPRIL40MGTABLET / ORALAB2006-02-2284e616aacf4f…
2026-08-18 06:07:402026-07A077622-001LISINOPRIL2.5MGTABLET / ORALAB2006-02-22caaa826d4ba7…
2026-08-18 06:07:402026-07A077622-002LISINOPRIL5MGTABLET / ORALAB2006-02-22caaa826d4ba7…
2026-08-18 06:07:402026-07A077622-003LISINOPRIL10MGTABLET / ORALAB2006-02-22caaa826d4ba7…
2026-08-18 06:07:402026-07A077622-004LISINOPRIL20MGTABLET / ORALAB2006-02-22caaa826d4ba7…
2026-08-18 06:07:402026-07A077622-005LISINOPRIL30MGTABLET / ORALAB2006-02-22caaa826d4ba7…
2026-08-18 06:07:402026-07A077622-006LISINOPRIL40MGTABLET / ORALAB2006-02-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077622-001LISINOPRIL2.5MGTABLET / ORALAB2006-02-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077622-002LISINOPRIL5MGTABLET / ORALAB2006-02-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077622-003LISINOPRIL10MGTABLET / ORALAB2006-02-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077622-004LISINOPRIL20MGTABLET / ORALAB2006-02-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077622-005LISINOPRIL30MGTABLET / ORALAB2006-02-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077622-006LISINOPRIL40MGTABLET / ORALAB2006-02-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077622-001LISINOPRIL2.5MGTABLET / ORALAB2006-02-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077622-002LISINOPRIL5MGTABLET / ORALAB2006-02-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077622-003LISINOPRIL10MGTABLET / ORALAB2006-02-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077622-004LISINOPRIL20MGTABLET / ORALAB2006-02-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077622-005LISINOPRIL30MGTABLET / ORALAB2006-02-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077622-006LISINOPRIL40MGTABLET / ORALAB2006-02-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A077622-001LISINOPRIL2.5MGTABLET / ORALAB2006-02-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077622-002LISINOPRIL5MGTABLET / ORALAB2006-02-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077622-003LISINOPRIL10MGTABLET / ORALAB2006-02-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077622-004LISINOPRIL20MGTABLET / ORALAB2006-02-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077622-005LISINOPRIL30MGTABLET / ORALAB2006-02-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077622-006LISINOPRIL40MGTABLET / ORALAB2006-02-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077622-001LISINOPRIL2.5MGTABLET / ORALAB2006-02-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077622-002LISINOPRIL5MGTABLET / ORALAB2006-02-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077622-003LISINOPRIL10MGTABLET / ORALAB2006-02-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077622-004LISINOPRIL20MGTABLET / ORALAB2006-02-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077622-005LISINOPRIL30MGTABLET / ORALAB2006-02-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077622-006LISINOPRIL40MGTABLET / ORALAB2006-02-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077622-001LISINOPRIL2.5MGTABLET / ORALAB2006-02-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077622-002LISINOPRIL5MGTABLET / ORALAB2006-02-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077622-003LISINOPRIL10MGTABLET / ORALAB2006-02-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077622-004LISINOPRIL20MGTABLET / ORALAB2006-02-22b8a1b40f171c…

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 22:38:342026-08A077622-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A077622-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A077622-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A077622-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A077622-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A077622-006AB184e616aacf4f…
2026-08-18 06:07:402026-07A077622-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077622-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077622-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077622-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077622-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077622-006AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077622-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077622-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077622-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077622-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077622-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077622-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077622-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077622-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077622-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077622-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077622-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077622-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077622-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077622-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077622-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077622-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077622-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077622-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077622-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077622-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077622-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077622-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077622-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077622-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077622-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077622-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077622-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077622-004AB1b8a1b40f171c…

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
LISINOPRIL5 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
0e6364a4-6d66-4151-8197-d45e2a762895Available 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
65862-038-00Lisinopril100 in 1 BOTTLETABLET10026
65862-038-01Lisinopril100 in 1 BOTTLETABLET10026
65862-038-05Lisinopril500 in 1 BOTTLETABLET50026
65862-038-30Lisinopril30 in 1 BOTTLETABLET3026
65862-038-99Lisinopril1000 in 1 BOTTLETABLET100026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-038-01EA - Each65862-038d48d8124-d9ad-4b91-b546-cb13cb897a9912012-07-24
65862-038-05EA - Each65862-038933c215e-3521-4cfb-8fab-5462767701c712012-07-24
65862-038-99EA - Each65862-038eefc1465-e277-430b-916e-5b3d73e9523a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LISINOPRILACTIVE INGREDIENTE7199S1YWRLISINOPRIL TABLET [AUROBINDO PHARMA LIMITED]19
LISINOPRIL ANHYDROUSACTIVE MOIETY7Q3P4BS2FDLISINOPRIL TABLET [AUROBINDO PHARMA LIMITED]19
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JLISINOPRIL TABLET [AUROBINDO PHARMA LIMITED]19
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LISINOPRIL TABLET [AUROBINDO PHARMA LIMITED]19
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLISINOPRIL TABLET [AUROBINDO PHARMA LIMITED]19
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LISINOPRIL TABLET [AUROBINDO PHARMA LIMITED]19
MANNITOLINACTIVE INGREDIENT3OWL53L36ALISINOPRIL TABLET [AUROBINDO PHARMA LIMITED]19
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLISINOPRIL TABLET [AUROBINDO PHARMA LIMITED]19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-038LISINOPRIL TABLET [AUROBINDO PHARMA LIMITED]26Current NDC, Legacy NDC, 5 package rows20230105_0e6364a4-6d66-4151-8197-d45e2a762895.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
LisinoprilLISINOPRILAurobindo Pharma Limited0e6364a4-6d66-4151-8197-d45e2a7628952026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077622
application number: ANDA077622
ndc (package): 65862-038-05
ndc (product): 65862-038
ndc11 (package): 65862003805

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314076lisinopril 10 MG Oral TabletPSN0e6364a4-6d66-4151-8197-d45e2a76289526
311353lisinopril 2.5 MG Oral TabletPSN0e6364a4-6d66-4151-8197-d45e2a76289526
314077lisinopril 20 MG Oral TabletPSN0e6364a4-6d66-4151-8197-d45e2a76289526
205326lisinopril 30 MG Oral TabletPSN0e6364a4-6d66-4151-8197-d45e2a76289526
197884lisinopril 40 MG Oral TabletPSN0e6364a4-6d66-4151-8197-d45e2a76289526
311354lisinopril 5 MG Oral TabletPSN0e6364a4-6d66-4151-8197-d45e2a76289526
314076lisinopril 10 MG Oral TabletSCD0e6364a4-6d66-4151-8197-d45e2a76289526
311353lisinopril 2.5 MG Oral TabletSCD0e6364a4-6d66-4151-8197-d45e2a76289526
314077lisinopril 20 MG Oral TabletSCD0e6364a4-6d66-4151-8197-d45e2a76289526
205326lisinopril 30 MG Oral TabletSCD0e6364a4-6d66-4151-8197-d45e2a76289526
197884lisinopril 40 MG Oral TabletSCD0e6364a4-6d66-4151-8197-d45e2a76289526
311354lisinopril 5 MG Oral TabletSCD0e6364a4-6d66-4151-8197-d45e2a76289526

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-038-0565862003805500 TABLET in 1 BOTTLE (65862-038-05) 500 tablet2006-02-220000-00-00NoNoCurrent