FDA.reportPublic FDA data

LISINOPRIL

Product NDC
50090-4885
11-digit product format
500904885
Labeler code
50090
Product ID
50090-4885_e2330f85-4aec-4c03-9c0e-400137136c01
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076180
Marketing category
ANDA
Marketing start
2011-11-01
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
Rxcui314076

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4885-02023-02-07C16284748780-1f386c649-dc62-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LISINOPRIL TABLETS safely and effectively. See full prescribing information for LISINOPRIL TABLETS LISINOPRIL tablets, for oral use Initial U.S. Approval: 1988
50090-4885-02023-01-30C16284748780-1f386c649-dc62-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LISINOPRIL TABLETS safely and effectively. See full prescribing information for LISINOPRIL TABLETS LISINOPRIL tablets, for oral use Initial U.S. Approval: 1988

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4885-0LISINOPRIL90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4885-0EA - Each50090-488533984115-872f-4236-8b87-de85c63d8e7112024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4885LISINOPRIL TABLET [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 1 package rows20230208_b5683ac4-59dc-4772-8bc6-984c698afbeb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314076lisinopril 10 MG Oral TabletPSNb5683ac4-59dc-4772-8bc6-984c698afbeb5
314076lisinopril 10 MG Oral TabletSCDb5683ac4-59dc-4772-8bc6-984c698afbeb5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4885-05009048850090 TABLET in 1 BOTTLE (50090-4885-0) 90 tablet2020-02-120000-00-00NoNoCurrent