FDA.reportPublic FDA data

lisinopril

Product NDC
10544-905
11-digit product format
105440905
Labeler code
10544
Product ID
10544-905_132542d2-a736-2043-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA075994
Marketing category
ANDA
Marketing start
2015-02-19
Marketing end
0000-00-00
Substance
LISINOPRIL
Active strength
10 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
10544-905-002020-01-31C16284748780-19d75b9d0-de16-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Lisinopril Tablets USP safely and effectively. See full prescribing information for Lisinopril Tablets USP. LISINOPRIL Tablets USP, for oral use Initial U.S. Approval: 1988

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-905-00lisinopril100 in 1 BOTTLETABLET1003

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LISINOPRILACTIVE INGREDIENTE7199S1YWRLISINOPRIL TABLET [BLENHEIM PHARMACAL, INC.]3
LISINOPRIL ANHYDROUSACTIVE MOIETY7Q3P4BS2FDLISINOPRIL TABLET [BLENHEIM PHARMACAL, INC.]3
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JLISINOPRIL TABLET [BLENHEIM PHARMACAL, INC.]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LISINOPRIL TABLET [BLENHEIM PHARMACAL, INC.]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLISINOPRIL TABLET [BLENHEIM PHARMACAL, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LISINOPRIL TABLET [BLENHEIM PHARMACAL, INC.]3
MANNITOLINACTIVE INGREDIENT3OWL53L36ALISINOPRIL TABLET [BLENHEIM PHARMACAL, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLISINOPRIL TABLET [BLENHEIM PHARMACAL, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-905LISINOPRIL TABLET [BLENHEIM PHARMACAL, INC.]3Legacy NDC, 1 package rows20150407_1221d5b1-e131-3866-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314076lisinopril 10 MG Oral TabletPSN1221d5b1-e131-3866-e054-00144ff8d46c3
314077lisinopril 20 MG Oral TabletPSN1221d5b1-e131-3866-e054-00144ff8d46c3
311354lisinopril 5 MG Oral TabletPSN1221d5b1-e131-3866-e054-00144ff8d46c3
314076lisinopril 10 MG Oral TabletSCD1221d5b1-e131-3866-e054-00144ff8d46c3
314077lisinopril 20 MG Oral TabletSCD1221d5b1-e131-3866-e054-00144ff8d46c3
311354lisinopril 5 MG Oral TabletSCD1221d5b1-e131-3866-e054-00144ff8d46c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-905-0010544090500100 in 1 BOTTLEHistorical