FDA.reportPublic FDA data

LISINOPRIL

Product NDC
50090-3763
11-digit product format
500903763
Labeler code
50090
Product ID
50090-3763_9ecf26b5-34ce-439e-b93b-2455703215e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076164
Marketing category
ANDA
Marketing start
2011-11-01
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

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
50090-3763-02023-02-07C16284748780-1f386c649-c053-0266-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
50090-3763-12023-02-07C16284748780-1f386c649-c053-0266-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
50090-3763-22023-02-07C16284748780-1f386c649-c053-0266-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
50090-3763-02023-01-30C16284748780-1f386c649-c053-0266-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
50090-3763-12023-01-30C16284748780-1f386c649-c053-0266-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
50090-3763-22023-01-30C16284748780-1f386c649-c053-0266-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
50090-3763-0LISINOPRIL30 in 1 BOTTLETABLET3016
50090-3763-1LISINOPRIL100 in 1 BOTTLETABLET10016
50090-3763-2LISINOPRIL90 in 1 BOTTLE, PLASTICTABLET9016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3763-0EA - Each50090-37635706f234-9edb-47ea-be82-d860e24d3c1a12021-11-09
50090-3763-1EA - Each50090-3763d1c2aab1-9c9c-4109-9e74-936eea42225612024-08-12
50090-3763-2EA - Each50090-3763fadf094a-b64a-4b44-82ce-b17f53663fa612021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3763LISINOPRIL TABLET [A-S MEDICATION SOLUTIONS]14Current NDC, Legacy NDC, 3 package rows20230329_a881df2d-e3b7-413f-b4bb-2c3d917b0811.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197884lisinopril 40 MG Oral TabletPSNa881df2d-e3b7-413f-b4bb-2c3d917b081116
197884lisinopril 40 MG Oral TabletSCDa881df2d-e3b7-413f-b4bb-2c3d917b081116

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3763-05009037630030 TABLET in 1 BOTTLE (50090-3763-0) 30 tablet2018-11-010000-00-00NoNoCurrent
50090-3763-150090376301100 TABLET in 1 BOTTLE (50090-3763-1) 100 tablet2019-09-300000-00-00NoNoCurrent
50090-3763-25009037630290 TABLET in 1 BOTTLE, PLASTIC (50090-3763-2) 90 tablet2014-11-280000-00-00NoNoCurrent