FDA.reportPublic FDA data

Lisinopril

Product NDC
33358-211
11-digit product format
333580211
Labeler code
33358
Product ID
33358-211_198f78ce-8573-417c-9a08-1362f731f6f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
RxChange Co.
Application
ANDA077321
Marketing category
ANDA
Marketing start
2014-11-18
Marketing end
0000-00-00
Substance
LISINOPRIL
Active strength
5 mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
33358-211-302020-01-31C16284748780-19d75b9d0-0df6-f424-e053-dadaa90a57ceLisinopril Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33358-211-30Lisinopril30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33358-211-30EA - Each33358-2114b19b345-1ad9-4ca4-be26-a92aa670abe912014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LISINOPRILACTIVE INGREDIENTE7199S1YWRLISINOPRIL TABLET [RXCHANGE CO.]2
LISINOPRIL ANHYDROUSACTIVE MOIETY7Q3P4BS2FDLISINOPRIL TABLET [RXCHANGE CO.]2
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JLISINOPRIL TABLET [RXCHANGE CO.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LISINOPRIL TABLET [RXCHANGE CO.]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ALISINOPRIL TABLET [RXCHANGE CO.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LISINOPRIL TABLET [RXCHANGE CO.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLISINOPRIL TABLET [RXCHANGE CO.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33358-211LISINOPRIL TABLET [RXCHANGE CO.]2Legacy NDC, 1 package rows20141120_1a0997e5-9285-4437-921d-f9405be544b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311354lisinopril 5 MG Oral TabletPSN1a0997e5-9285-4437-921d-f9405be544b62
311354lisinopril 5 MG Oral TabletSCD1a0997e5-9285-4437-921d-f9405be544b62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33358-211-303335802113030 in 1 BOTTLEHistorical