FDA.reportPublic FDA data

Lisinopril

Product NDC
50090-3175
11-digit product format
500903175
Labeler code
50090
Product ID
50090-3175_f0d97714-8a8c-488e-9a27-4ffbcaf1f5c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077321
Marketing category
ANDA
Marketing start
2017-04-17
Substance
LISINOPRIL
Active strength
30 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
LISINOPRIL30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiE7199S1YWR
Rxcui205326

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3175-02023-02-07C16284748780-1f386c64a-1ca7-0266-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
50090-3175-12023-02-07C16284748780-1f386c64a-1ca7-0266-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
50090-3175-02023-01-30C16284748780-1f386c64a-1ca7-0266-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
50090-3175-12023-01-30C16284748780-1f386c64a-1ca7-0266-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
50090-3175-0Lisinopril30 in 1 BOTTLETABLET3012
50090-3175-1Lisinopril90 in 1 BOTTLE, PLASTICTABLET9012
50090-3175-2Lisinopril100 in 1 BOTTLETABLET10012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3175-0EA - Each50090-3175cc05544d-5876-4686-99bf-e7c27eb1dcf012019-05-02
50090-3175-1EA - Each50090-31756978efa7-9d75-49b4-a454-ec4b33993ed512019-05-02
50090-3175-2EA - Each50090-317578c4bd5d-e3f5-41c7-8f39-948e7bdd503212024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3175LISINOPRIL TABLET [A-S MEDICATION SOLUTIONS]12Current NDC, Legacy NDC, 3 package rows20230323_051375d4-7d38-45b3-9ca4-f2cd1f527b1b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205326lisinopril 30 MG Oral TabletPSN051375d4-7d38-45b3-9ca4-f2cd1f527b1b12
205326lisinopril 30 MG Oral TabletSCD051375d4-7d38-45b3-9ca4-f2cd1f527b1b12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3175-05009031750030 TABLET in 1 BOTTLE (50090-3175-0) 30 tablet2017-10-160000-00-00NoNoCurrent
50090-3175-15009031750190 TABLET in 1 BOTTLE, PLASTIC (50090-3175-1) 90 tablet2017-04-170000-00-00NoNoCurrent
50090-3175-250090317502100 TABLET in 1 BOTTLE (50090-3175-2) 100 tablet2023-03-09NoNoHistorical