FDA.reportPublic FDA data

Lisinopril

Product NDC
60687-678
11-digit product format
606870678
Labeler code
60687
Product ID
60687-678_21eed451-936b-146c-e063-6294a90af62b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA077321
Marketing category
ANDA
Marketing start
2022-03-30
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lisinopril
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LISINOPRIL40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiE7199S1YWR
Rxcui197884, 311353, 311354

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
60687-678-01Lisinopril100 in 1 CARTONTABLET1002
60687-678-11Lisinopril1 in 1 BLISTER PACKTABLET12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-678-01EA - Each60687-6783dd8a42a-2dad-48f5-a5cb-ce11df41e28612022-04-06
60687-678-11EA - Each60687-67884076908-c269-4c35-b731-69facb21a8ad12022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-678LISINOPRIL TABLET [AMERICAN HEALTH PACKAGING]2Current NDC, Legacy NDC, 2 package rows20240913_50ae0dfe-d961-4bc0-9898-71f69f9a5403.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311353lisinopril 2.5 MG Oral TabletPSN50ae0dfe-d961-4bc0-9898-71f69f9a54032
197884lisinopril 40 MG Oral TabletPSN50ae0dfe-d961-4bc0-9898-71f69f9a54032
311354lisinopril 5 MG Oral TabletPSN50ae0dfe-d961-4bc0-9898-71f69f9a54032
311353lisinopril 2.5 MG Oral TabletSCD50ae0dfe-d961-4bc0-9898-71f69f9a54032
197884lisinopril 40 MG Oral TabletSCD50ae0dfe-d961-4bc0-9898-71f69f9a54032
311354lisinopril 5 MG Oral TabletSCD50ae0dfe-d961-4bc0-9898-71f69f9a54032

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-678-0160687067801100 BLISTER PACK in 1 CARTON (60687-678-01) / 1 TABLET in 1 BLISTER PACK (60687-678-11) 100 blister pack2022-03-300000-00-00NoNoCurrent
60687-678-11606870678111 in 1 BLISTER PACKHistorical