FDA.reportPublic FDA data

Lisinopril

Product NDC
63629-1761
11-digit product format
636291761
Labeler code
63629
Product ID
63629-1761_e0915e77-f16e-4ca1-a9c3-2b4736b5cc98
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
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
LISINOPRIL5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiE7199S1YWR
Rxcui311354

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-1761-1Lisinopril30 in 1 BOTTLETABLET3019
63629-1761-2Lisinopril90 in 1 BOTTLETABLET9019
63629-1761-3Lisinopril60 in 1 BOTTLETABLET6019
63629-1761-4Lisinopril100 in 1 BOTTLETABLET10019
63629-1761-5Lisinopril10 in 1 BOTTLETABLET1019
63629-1761-6Lisinopril28 in 1 BOTTLETABLET2819

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1761-1EA - Each63629-176130f41eaf-4f31-4f96-85f3-4d9587070f2d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LISINOPRILACTIVE INGREDIENTE7199S1YWRLISINOPRIL TABLET [BRYANT RANCH PREPACK]3
LISINOPRIL ANHYDROUSACTIVE MOIETY7Q3P4BS2FDLISINOPRIL TABLET [BRYANT RANCH PREPACK]3
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JLISINOPRIL TABLET [BRYANT RANCH PREPACK]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LISINOPRIL TABLET [BRYANT RANCH PREPACK]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LISINOPRIL TABLET [BRYANT RANCH PREPACK]3
MANNITOLINACTIVE INGREDIENT3OWL53L36ALISINOPRIL TABLET [BRYANT RANCH PREPACK]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LISINOPRIL TABLET [BRYANT RANCH PREPACK]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLISINOPRIL TABLET [BRYANT RANCH PREPACK]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1761LISINOPRIL TABLET [BRYANT RANCH PREPACK]18Current NDC, Legacy NDC, 6 package rows20240828_59fd2167-4da4-9143-83bd-3b6aa5051511.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311354lisinopril 5 MG Oral TabletPSN59fd2167-4da4-9143-83bd-3b6aa505151119
311354lisinopril 5 MG Oral TabletSCD59fd2167-4da4-9143-83bd-3b6aa505151119

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1761-16362917610130 TABLET in 1 BOTTLE (63629-1761-1) 30 tablet2009-08-240000-00-00NoNoCurrent
63629-1761-26362917610290 TABLET in 1 BOTTLE (63629-1761-2) 90 tablet2010-11-050000-00-00NoNoCurrent
63629-1761-36362917610360 TABLET in 1 BOTTLE (63629-1761-3) 60 tablet2013-01-110000-00-00NoNoCurrent
63629-1761-463629176104100 TABLET in 1 BOTTLE (63629-1761-4) 100 tablet2014-10-070000-00-00NoNoCurrent
63629-1761-56362917610510 TABLET in 1 BOTTLE (63629-1761-5) 10 tablet2019-07-220000-00-00NoNoCurrent
63629-1761-66362917610628 TABLET in 1 BOTTLE (63629-1761-6) 28 tablet2023-03-010000-00-00NoNoCurrent