FDA.reportPublic FDA data

Lisinopril

Product NDC
55648-928
11-digit product format
556480928
Labeler code
55648
Product ID
55648-928_f68b2093-d117-4a59-aa38-83fbe1e48e87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
Wockhardt Limited
Application
ANDA078402
Marketing category
ANDA
Marketing start
2007-04-19
Marketing end
0000-00-00
Substance
LISINOPRIL
Active strength
5 mg/1
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55648-928-012020-01-31C16284748780-19d75b9cf-d55c-f424-e053-dadaa90a57ceLisinopril Tablets USP
55648-928-022020-01-31C16284748780-19d75b9cf-d55c-f424-e053-dadaa90a57ceLisinopril Tablets USP
55648-928-032020-01-31C16284748780-19d75b9cf-d55c-f424-e053-dadaa90a57ceLisinopril Tablets USP
55648-928-052020-01-31C16284748780-19d75b9cf-d55c-f424-e053-dadaa90a57ceLisinopril Tablets USP
55648-928-062020-01-31C16284748780-19d75b9cf-d55c-f424-e053-dadaa90a57ceLisinopril Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-928-01Lisinopril100 in 1 BOTTLETABLET1001
55648-928-02Lisinopril3000 in 1 BOTTLETABLET30001
55648-928-03Lisinopril10 in 1 BLISTER PACKTABLET101
55648-928-03Lisinopril10 in 1 CARTONTABLET101
55648-928-05Lisinopril500 in 1 BOTTLETABLET5001
55648-928-06Lisinopril1000 in 1 BOTTLETABLET10001

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LISINOPRILACTIVE INGREDIENTE7199S1YWRLISINOPRIL TABLET [LIBERTY PHARMACEUTICALS, INC.]2
LISINOPRIL ANHYDROUSACTIVE MOIETY7Q3P4BS2FDLISINOPRIL TABLET [LIBERTY PHARMACEUTICALS, INC.]2
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPLISINOPRIL TABLET [LIBERTY PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LISINOPRIL TABLET [LIBERTY PHARMACEUTICALS, INC.]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ALISINOPRIL TABLET [LIBERTY PHARMACEUTICALS, INC.]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ELISINOPRIL TABLET [LIBERTY PHARMACEUTICALS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LISINOPRIL TABLET [LIBERTY PHARMACEUTICALS, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLISINOPRIL TABLET [LIBERTY PHARMACEUTICALS, INC.]2
LISINOPRILACTIVE INGREDIENTE7199S1YWRLISINOPRIL TABLET [WOCKHARDT LIMITED]1
LISINOPRILACTIVE MOIETYE7199S1YWRLISINOPRIL TABLET [WOCKHARDT LIMITED]1
BROWN IRON OXIDEINACTIVE INGREDIENT1N032N7MFOLISINOPRIL TABLET [WOCKHARDT LIMITED]1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPLISINOPRIL TABLET [WOCKHARDT LIMITED]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LISINOPRIL TABLET [WOCKHARDT LIMITED]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLISINOPRIL TABLET [WOCKHARDT LIMITED]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LISINOPRIL TABLET [WOCKHARDT LIMITED]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ALISINOPRIL TABLET [WOCKHARDT LIMITED]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ELISINOPRIL TABLET [WOCKHARDT LIMITED]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LISINOPRIL TABLET [WOCKHARDT LIMITED]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLISINOPRIL TABLET [WOCKHARDT LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-928LISINOPRIL TABLET [WOCKHARDT LIMITED]1Legacy NDC, 6 package rows20120227_a2b1db6a-3a3e-4d10-b627-3e83c9f52f59.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311354lisinopril 5 MG Oral TabletPSN19563d4f-d5dc-4fa5-a354-f2203bd64c712
311354lisinopril 5 MG Oral TabletSCD19563d4f-d5dc-4fa5-a354-f2203bd64c712
314076lisinopril 10 MG Oral TabletPSNa2b1db6a-3a3e-4d10-b627-3e83c9f52f591
311353lisinopril 2.5 MG Oral TabletPSNa2b1db6a-3a3e-4d10-b627-3e83c9f52f591
314077lisinopril 20 MG Oral TabletPSNa2b1db6a-3a3e-4d10-b627-3e83c9f52f591
205326lisinopril 30 MG Oral TabletPSNa2b1db6a-3a3e-4d10-b627-3e83c9f52f591
197884lisinopril 40 MG Oral TabletPSNa2b1db6a-3a3e-4d10-b627-3e83c9f52f591
311354lisinopril 5 MG Oral TabletPSNa2b1db6a-3a3e-4d10-b627-3e83c9f52f591
314076lisinopril 10 MG Oral TabletSCDa2b1db6a-3a3e-4d10-b627-3e83c9f52f591
311353lisinopril 2.5 MG Oral TabletSCDa2b1db6a-3a3e-4d10-b627-3e83c9f52f591
314077lisinopril 20 MG Oral TabletSCDa2b1db6a-3a3e-4d10-b627-3e83c9f52f591
205326lisinopril 30 MG Oral TabletSCDa2b1db6a-3a3e-4d10-b627-3e83c9f52f591
197884lisinopril 40 MG Oral TabletSCDa2b1db6a-3a3e-4d10-b627-3e83c9f52f591
311354lisinopril 5 MG Oral TabletSCDa2b1db6a-3a3e-4d10-b627-3e83c9f52f591

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-928-0155648092801100 in 1 BOTTLEHistorical
55648-928-02556480928023000 in 1 BOTTLEHistorical
55648-928-035564809280310 in 1 BLISTER PACKHistorical
55648-928-0555648092805500 in 1 BOTTLEHistorical
55648-928-06556480928061000 in 1 BOTTLEHistorical