FDA.reportPublic FDA data

LISINOPRIL

Product NDC
50090-3774
11-digit product format
500903774
Labeler code
50090
Product ID
50090-3774_4449a55a-8d7e-4b1a-a27d-f68819611007
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
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
50090-3774-02023-02-06C16284748780-1f386c649-f80b-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
50090-3774-32023-02-06C16284748780-1f386c649-f80b-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
50090-3774-42023-02-06C16284748780-1f386c649-f80b-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
50090-3774-52023-02-06C16284748780-1f386c649-f80b-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
50090-3774-02023-01-30C16284748780-1f386c649-f80b-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
50090-3774-32023-01-30C16284748780-1f386c649-f80b-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
50090-3774-42023-01-30C16284748780-1f386c649-f80b-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
50090-3774-52023-01-30C16284748780-1f386c649-f80b-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
50090-3774-0LISINOPRIL30 in 1 BOTTLETABLET3013
50090-3774-1LISINOPRIL100 in 1 BOTTLETABLET10013
50090-3774-3LISINOPRIL60 in 1 BOTTLE, PLASTICTABLET6013
50090-3774-4LISINOPRIL200 in 1 BOTTLE, PLASTICTABLET20013
50090-3774-5LISINOPRIL90 in 1 BOTTLETABLET9013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3774-0EA - Each50090-37740a97024c-9617-412d-ba80-7e0e5c57ba9412021-10-08
50090-3774-1EA - Each50090-37747d233a92-7f9a-464d-b8f1-fb35f3bf0f0212024-08-12
50090-3774-3EA - Each50090-377471047991-f401-4037-890b-6244656a879812021-08-05
50090-3774-4EA - Each50090-3774543fb151-f8bd-4f5e-a912-b88cb4ace7cf12021-10-08
50090-3774-5EA - Each50090-377461114ee9-af47-4805-ae51-d049d0b5798b12025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3774LISINOPRIL TABLET [A-S MEDICATION SOLUTIONS]13Current NDC, Legacy NDC, 5 package rows20241025_8f63c3e0-0b3f-4a04-a592-2ce10dfda202.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314076lisinopril 10 MG Oral TabletPSN8f63c3e0-0b3f-4a04-a592-2ce10dfda20213
314076lisinopril 10 MG Oral TabletSCD8f63c3e0-0b3f-4a04-a592-2ce10dfda20213

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3774-05009037740030 TABLET in 1 BOTTLE (50090-3774-0) 30 tablet2018-11-050000-00-00NoNoCurrent
50090-3774-150090377401100 TABLET in 1 BOTTLE (50090-3774-1) 100 tablet2023-03-27NoNoHistorical
50090-3774-35009037740360 TABLET in 1 BOTTLE, PLASTIC (50090-3774-3) 60 tablet2014-11-280000-00-00NoNoCurrent
50090-3774-450090377404200 TABLET in 1 BOTTLE, PLASTIC (50090-3774-4) 200 tablet2014-11-280000-00-00NoNoCurrent
50090-3774-55009037740590 TABLET in 1 BOTTLE (50090-3774-5) 90 tablet2019-01-170000-00-00NoNoCurrent