Zestril

Product NDC
52427-443
11-digit product format
524270443
Labeler code
52427
Product ID
52427-443_443df970-cabf-11ee-37bb-7912e4e6ac21
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
Almatica Pharma LLC
Application
NDA019777
Marketing category
NDA
Marketing start
2015-04-07
Marketing end
0000-00-00
Substance
LISINOPRIL
Active strength
40 mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52427-443-902020-07-22C16284748780-1ab0e2407-3133-f274-e053-dbdaa90a6471a95727ae-2bf1-e675-4a36-71043a8af3b8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52427-443-90EA - Each52427-4432781eef0-7787-4c60-bcbb-dd1db7d4aba012015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LISINOPRILACTIVE INGREDIENTE7199S1YWRZESTRIL (LISINOPRIL) TABLET [ALMATICA PHARMA INC.]6
LISINOPRIL ANHYDROUSACTIVE MOIETY7Q3P4BS2FDZESTRIL (LISINOPRIL) TABLET [ALMATICA PHARMA INC.]6
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPZESTRIL (LISINOPRIL) TABLET [ALMATICA PHARMA INC.]6
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZESTRIL (LISINOPRIL) TABLET [ALMATICA PHARMA INC.]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTZESTRIL (LISINOPRIL) TABLET [ALMATICA PHARMA INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZESTRIL (LISINOPRIL) TABLET [ALMATICA PHARMA INC.]6
MANNITOLINACTIVE INGREDIENT3OWL53L36AZESTRIL (LISINOPRIL) TABLET [ALMATICA PHARMA INC.]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJZESTRIL (LISINOPRIL) TABLET [ALMATICA PHARMA INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52427-443ZESTRIL (LISINOPRIL) TABLET [ALMATICA PHARMA LLC]16Legacy NDC20241122_a95727ae-2bf1-e675-4a36-71043a8af3b8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52427-443-905242704439090 TABLET in 1 BOTTLE (52427-443-90) 90 tablet2017-07-210000-00-00NoNoCurrent