FDA.reportPublic FDA data

Lisinopril

Product NDC
63629-5247
11-digit product format
636295247
Labeler code
63629
Product ID
63629-5247_8c1d3ddf-12a0-4727-9381-1f2fb0acc837
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077321
Marketing category
ANDA
Marketing start
2006-01-13
Substance
LISINOPRIL
Active strength
2.5 mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lisinopril
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LISINOPRIL2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiE7199S1YWR
Rxcui311353

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-5247-1Lisinopril30 in 1 BOTTLETABLET301011
63629-5247-2Lisinopril90 in 1 BOTTLETABLET901011
63629-5247-3Lisinopril60 in 1 BOTTLETABLET601011
63629-5247-4Lisinopril10 in 1 BOTTLETABLET101011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-5247-1EA - Each63629-5247eda8c904-bd48-411c-91be-9f5ffbc9c84212015-10-02
63629-5247-2EA - Each63629-524724c62aa5-aeee-4e3c-bbd3-45e06c52c60612015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LISINOPRILACTIVE INGREDIENTE7199S1YWRLISINOPRIL TABLET [BRYANT RANCH PREPACK]1001
LISINOPRIL ANHYDROUSACTIVE MOIETY7Q3P4BS2FDLISINOPRIL TABLET [BRYANT RANCH PREPACK]1001
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JLISINOPRIL TABLET [BRYANT RANCH PREPACK]1001
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LISINOPRIL TABLET [BRYANT RANCH PREPACK]1001
MANNITOLINACTIVE INGREDIENT3OWL53L36ALISINOPRIL TABLET [BRYANT RANCH PREPACK]1001
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LISINOPRIL TABLET [BRYANT RANCH PREPACK]1001
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLISINOPRIL TABLET [BRYANT RANCH PREPACK]1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-5247LISINOPRIL TABLET [BRYANT RANCH PREPACK]1010Current NDC, Legacy NDC, 4 package rows20240502_08b0555e-41d2-44c3-b27b-ad5d701378dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311353lisinopril 2.5 MG Oral TabletPSN08b0555e-41d2-44c3-b27b-ad5d701378dc1011
311353lisinopril 2.5 MG Oral TabletSCD08b0555e-41d2-44c3-b27b-ad5d701378dc1011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-5247-16362952470130 TABLET in 1 BOTTLE (63629-5247-1) 30 tablet2014-02-270000-00-00NoNoCurrent
63629-5247-26362952470290 TABLET in 1 BOTTLE (63629-5247-2) 90 tablet2014-03-070000-00-00NoNoCurrent
63629-5247-36362952470360 TABLET in 1 BOTTLE (63629-5247-3) 60 tablet2024-04-020000-00-00NoNoCurrent
63629-5247-46362952470410 TABLET in 1 BOTTLE (63629-5247-4) 10 tablet2024-04-020000-00-00NoNoCurrent