Lisinopril

Product NDC
82009-064
11-digit product format
820090064
Labeler code
82009
Product ID
82009-064_d2b42923-6e5f-47a1-9b31-4d019142a102
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
Quallent Pharmaceuticals Health LLC
Application
ANDA077321
Marketing category
ANDA
Marketing start
2023-07-07
Substance
LISINOPRIL
Active strength
10 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
LISINOPRIL10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiE7199S1YWR
Rxcui197884, 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
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82009-064-10Lisinopril1000 in 1 BOTTLETABLET10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82009-064-10EA - Each82009-0648f6ce739-b98b-46b2-b226-3b5530d8419812023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82009-064LISINOPRIL TABLET [QUALLENT PHARMACEUTICALS HEALTH LLC]1Current NDC, 1 package rows20230708_f2e09150-22f2-4028-b214-917d686200ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314076lisinopril 10 MG Oral TabletPSNf2e09150-22f2-4028-b214-917d686200ad1
311353lisinopril 2.5 MG Oral TabletPSNf2e09150-22f2-4028-b214-917d686200ad1
314077lisinopril 20 MG Oral TabletPSNf2e09150-22f2-4028-b214-917d686200ad1
197884lisinopril 40 MG Oral TabletPSNf2e09150-22f2-4028-b214-917d686200ad1
311354lisinopril 5 MG Oral TabletPSNf2e09150-22f2-4028-b214-917d686200ad1
314076lisinopril 10 MG Oral TabletSCDf2e09150-22f2-4028-b214-917d686200ad1
311353lisinopril 2.5 MG Oral TabletSCDf2e09150-22f2-4028-b214-917d686200ad1
314077lisinopril 20 MG Oral TabletSCDf2e09150-22f2-4028-b214-917d686200ad1
197884lisinopril 40 MG Oral TabletSCDf2e09150-22f2-4028-b214-917d686200ad1
311354lisinopril 5 MG Oral TabletSCDf2e09150-22f2-4028-b214-917d686200ad1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82009-064-10820090064101000 TABLET in 1 BOTTLE (82009-064-10) 1000 tablet2023-07-07NoNoHistorical