FDA.reportPublic FDA data

Lisinopril

Product NDC
68387-521
11-digit product format
683870521
Labeler code
68387
Product ID
68387-521_986cbe30-d77a-4ab9-95ba-891b453e6309
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
Keltman Pharmaceuticals Inc.
Application
ANDA076063
Marketing category
ANDA
Marketing start
2010-12-10
Marketing end
0000-00-00
Substance
LISINOPRIL
Active strength
20 mg/1
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
68387-521-102019-10-29C16284748780-1960f7f55-daba-8e05-e053-dbdaa90a074aLISINOPRIL TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68387-521-10Lisinopril10 in 1 BOTTLE, PLASTICTABLET101

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LISINOPRILACTIVE INGREDIENTE7199S1YWRLISINOPRIL TABLET [KELTMAN PHARMACEUTICALS INC.]1
LISINOPRILACTIVE MOIETYE7199S1YWRLISINOPRIL TABLET [KELTMAN PHARMACEUTICALS INC.]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JLISINOPRIL TABLET [KELTMAN PHARMACEUTICALS INC.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LISINOPRIL TABLET [KELTMAN PHARMACEUTICALS INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LISINOPRIL TABLET [KELTMAN PHARMACEUTICALS INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LISINOPRIL TABLET [KELTMAN PHARMACEUTICALS INC.]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ALISINOPRIL TABLET [KELTMAN PHARMACEUTICALS INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LISINOPRIL TABLET [KELTMAN PHARMACEUTICALS INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLISINOPRIL TABLET [KELTMAN PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68387-521LISINOPRIL TABLET [KELTMAN PHARMACEUTICALS INC.]1Legacy NDC, 1 package rows20101214_a840cf7e-e9e6-4622-92b1-1e81b4c3bd24.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314077lisinopril 20 MG Oral TabletPSNa840cf7e-e9e6-4622-92b1-1e81b4c3bd241
314077lisinopril 20 MG Oral TabletSCDa840cf7e-e9e6-4622-92b1-1e81b4c3bd241

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68387-521-106838705211010 in 1 BOTTLE, PLASTICHistorical