FDA.reportPublic FDA data

Lisinopril

Product NDC
51138-063
11-digit product format
511380063
Labeler code
51138
Product ID
51138-063_fd8130de-c98c-4485-9e3e-93a19f20ab87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
Med-Health Pharma, LLC
Application
ANDA076063
Marketing category
ANDA
Marketing start
2011-01-05
Marketing end
0000-00-00
Substance
LISINOPRIL
Active strength
3 mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
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
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51138-063-302019-11-27C16284748780-19855d018-e4e0-cd31-e053-dbdaa90ab51aLISINOPRIL TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51138-063-30Lisinopril30 in 1 BOTTLE, PLASTICTABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51138-063-30EA - Each51138-063e999f45d-b8d1-4ae8-ac90-09cc341ea25a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LISINOPRILACTIVE INGREDIENTE7199S1YWRLISINOPRIL TABLET [MED-HEALTH PHARMA, LLC]2
LISINOPRIL ANHYDROUSACTIVE MOIETY7Q3P4BS2FDLISINOPRIL TABLET [MED-HEALTH PHARMA, LLC]2
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JLISINOPRIL TABLET [MED-HEALTH PHARMA, LLC]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LISINOPRIL TABLET [MED-HEALTH PHARMA, LLC]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LISINOPRIL TABLET [MED-HEALTH PHARMA, LLC]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLISINOPRIL TABLET [MED-HEALTH PHARMA, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LISINOPRIL TABLET [MED-HEALTH PHARMA, LLC]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ALISINOPRIL TABLET [MED-HEALTH PHARMA, LLC]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LISINOPRIL TABLET [MED-HEALTH PHARMA, LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLISINOPRIL TABLET [MED-HEALTH PHARMA, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51138-063LISINOPRIL TABLET [MED-HEALTH PHARMA, LLC]2Legacy NDC, 1 package rows20130418_c7e7d939-8f5c-4443-b6cf-c306e06ddf67.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314076lisinopril 10 MG Oral TabletPSNc7e7d939-8f5c-4443-b6cf-c306e06ddf672
311353lisinopril 2.5 MG Oral TabletPSNc7e7d939-8f5c-4443-b6cf-c306e06ddf672
314077lisinopril 20 MG Oral TabletPSNc7e7d939-8f5c-4443-b6cf-c306e06ddf672
205326lisinopril 30 MG Oral TabletPSNc7e7d939-8f5c-4443-b6cf-c306e06ddf672
197884lisinopril 40 MG Oral TabletPSNc7e7d939-8f5c-4443-b6cf-c306e06ddf672
311354lisinopril 5 MG Oral TabletPSNc7e7d939-8f5c-4443-b6cf-c306e06ddf672
314076lisinopril 10 MG Oral TabletSCDc7e7d939-8f5c-4443-b6cf-c306e06ddf672
311353lisinopril 2.5 MG Oral TabletSCDc7e7d939-8f5c-4443-b6cf-c306e06ddf672
314077lisinopril 20 MG Oral TabletSCDc7e7d939-8f5c-4443-b6cf-c306e06ddf672
205326lisinopril 30 MG Oral TabletSCDc7e7d939-8f5c-4443-b6cf-c306e06ddf672
197884lisinopril 40 MG Oral TabletSCDc7e7d939-8f5c-4443-b6cf-c306e06ddf672
311354lisinopril 5 MG Oral TabletSCDc7e7d939-8f5c-4443-b6cf-c306e06ddf672

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
51138-063-305113800633030 in 1 BOTTLE, PLASTICHistorical