FDA.reportPublic FDA data

Lisinopril

Product NDC
68001-335
11-digit product format
680010335
Labeler code
68001
Product ID
68001-335_c5fac2c4-de1f-49d3-e053-2a95a90a5285
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA077321
Marketing category
ANDA
Marketing start
2017-08-01
Substance
LISINOPRIL
Active strength
20 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
LISINOPRIL20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiE7199S1YWR
Rxcui197884, 205326, 311353, 311354, 314076, 314077

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
68001-335-00Lisinopril100 in 1 BOTTLETABLET10011
68001-335-08Lisinopril1000 in 1 BOTTLETABLET100011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-335-00EA - Each68001-33561a0e164-12e3-47f1-9444-0deb8aa4f13612017-10-13
68001-335-08EA - Each68001-335145bdb24-9cd7-4c7f-8c31-a4a45613217812017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-335LISINOPRIL TABLET [BLUEPOINT LABORATORIES]11Current NDC, Legacy NDC, 2 package rows20210701_34ebeea1-6812-4697-84c4-b2ae4f39e55f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314076lisinopril 10 MG Oral TabletPSN34ebeea1-6812-4697-84c4-b2ae4f39e55f11
311353lisinopril 2.5 MG Oral TabletPSN34ebeea1-6812-4697-84c4-b2ae4f39e55f11
314077lisinopril 20 MG Oral TabletPSN34ebeea1-6812-4697-84c4-b2ae4f39e55f11
205326lisinopril 30 MG Oral TabletPSN34ebeea1-6812-4697-84c4-b2ae4f39e55f11
197884lisinopril 40 MG Oral TabletPSN34ebeea1-6812-4697-84c4-b2ae4f39e55f11
311354lisinopril 5 MG Oral TabletPSN34ebeea1-6812-4697-84c4-b2ae4f39e55f11
314076lisinopril 10 MG Oral TabletSCD34ebeea1-6812-4697-84c4-b2ae4f39e55f11
311353lisinopril 2.5 MG Oral TabletSCD34ebeea1-6812-4697-84c4-b2ae4f39e55f11
314077lisinopril 20 MG Oral TabletSCD34ebeea1-6812-4697-84c4-b2ae4f39e55f11
205326lisinopril 30 MG Oral TabletSCD34ebeea1-6812-4697-84c4-b2ae4f39e55f11
197884lisinopril 40 MG Oral TabletSCD34ebeea1-6812-4697-84c4-b2ae4f39e55f11
311354lisinopril 5 MG Oral TabletSCD34ebeea1-6812-4697-84c4-b2ae4f39e55f11
314077lisinopril 20 MG Oral TabletPSN266e6bc3-2465-e2e3-e063-6394a90a7adb1
314077lisinopril 20 MG Oral TabletSCD266e6bc3-2465-e2e3-e063-6394a90a7adb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-335-0068001033500100 TABLET in 1 BOTTLE (68001-335-00) 100 tablet2017-08-010000-00-00NoNoCurrent
68001-335-08680010335081000 TABLET in 1 BOTTLE (68001-335-08) 1000 tablet2017-08-010000-00-00NoNoCurrent