FDA.reportPublic FDA data

Lisinopril

Product NDC
0440-7674
11-digit product format
004407674
Labeler code
0440
Product ID
0440-7674_5882cbb4-7d17-4c90-aff3-db64a7831f94
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
Liberty Pharmaceuticals, Inc.
Application
ANDA078402
Marketing category
ANDA
Marketing start
2007-04-19
Marketing end
0000-00-00
Substance
LISINOPRIL
Active strength
5 mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]
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
0440-7674-902020-01-31C16284748780-19d75b9d0-d2e8-f424-e053-dadaa90a57ceLisinopril Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0440-7674-90Lisinopril90 in 1 BOTTLE, PLASTICTABLET902

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0440-7674LISINOPRIL TABLET [LIBERTY PHARMACEUTICALS, INC.]2Legacy NDC, 1 package rows20140404_19563d4f-d5dc-4fa5-a354-f2203bd64c71.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0440-7674-900044076749090 in 1 BOTTLE, PLASTICHistorical