FDA.reportPublic FDA data

Lisinopril

Product NDC
65862-039
11-digit product format
658620039
Labeler code
65862
Product ID
65862-039_02e12641-9edf-4791-8684-5f148f3ed574
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
10 mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lisinopril
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LISINOPRIL10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiE7199S1YWR
Rxcui197884, 205326, 311353, 311354, 314076, 314077

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
65862-039-00Lisinopril100 in 1 BOTTLETABLET10026
65862-039-01Lisinopril100 in 1 BOTTLETABLET10026
65862-039-05Lisinopril500 in 1 BOTTLETABLET50026
65862-039-30Lisinopril30 in 1 BOTTLETABLET3026
65862-039-99Lisinopril1000 in 1 BOTTLETABLET100026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-039-01EA - Each65862-0396ea353b1-631d-4e2f-b5a1-f4f42ea1d3f212012-07-24
65862-039-05EA - Each65862-039a9484c41-facd-4c66-89ec-d5254ab820c312012-07-24
65862-039-99EA - Each65862-03950717d5a-7a02-4e3b-b330-99959b96a21912012-07-24

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
LISINOPRILACTIVE INGREDIENTE7199S1YWRLISINOPRIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
LISINOPRILACTIVE MOIETYE7199S1YWRLISINOPRIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JLISINOPRIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLISINOPRIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LISINOPRIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
MANNITOLINACTIVE INGREDIENT3OWL53L36ALISINOPRIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLISINOPRIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-039LISINOPRIL TABLET [AUROBINDO PHARMA LIMITED]26Current NDC, Legacy NDC, 5 package rows20230105_0e6364a4-6d66-4151-8197-d45e2a762895.zip

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
314076lisinopril 10 MG Oral TabletPSN1979fd2a-7e2b-4d9a-9286-1066a0da944c3
314077lisinopril 20 MG Oral TabletPSN1979fd2a-7e2b-4d9a-9286-1066a0da944c3
314076lisinopril 10 MG Oral TabletSCD1979fd2a-7e2b-4d9a-9286-1066a0da944c3
314077lisinopril 20 MG Oral TabletSCD1979fd2a-7e2b-4d9a-9286-1066a0da944c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-039-0065862003900100 TABLET in 1 BOTTLE (65862-039-00) 100 tablet2006-02-220000-00-00NoNoCurrent
65862-039-0165862003901100 TABLET in 1 BOTTLE (65862-039-01) 100 tablet2006-02-220000-00-00NoNoCurrent
65862-039-0565862003905500 TABLET in 1 BOTTLE (65862-039-05) 500 tablet2006-02-220000-00-00NoNoCurrent
65862-039-306586200393030 TABLET in 1 BOTTLE (65862-039-30) 30 tablet2006-02-220000-00-00NoNoCurrent
65862-039-99658620039991000 TABLET in 1 BOTTLE (65862-039-99) 1000 tablet2006-02-220000-00-00NoNoCurrent