FDA.reportPublic FDA data

Lisinopril

Product NDC
10544-585
11-digit product format
105440585
Labeler code
10544
Product ID
10544-585_10ddc30d-bacc-1c74-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA075743
Marketing category
ANDA
Marketing start
2014-02-28
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
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10544-585-302020-01-31C16284748780-19d75b9d0-4801-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
10544-585-30Lisinopril30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-585-30EA - Each10544-5858ad5ba2c-9880-45b3-ae51-82e963d64bd312015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LISINOPRILACTIVE INGREDIENTE7199S1YWRLISINOPRIL TABLET [BLENHEIM PHARMACAL, INC.]2
LISINOPRIL ANHYDROUSACTIVE MOIETY7Q3P4BS2FDLISINOPRIL TABLET [BLENHEIM PHARMACAL, INC.]2
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPLISINOPRIL TABLET [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LISINOPRIL TABLET [BLENHEIM PHARMACAL, INC.]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ALISINOPRIL TABLET [BLENHEIM PHARMACAL, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLISINOPRIL TABLET [BLENHEIM PHARMACAL, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1ULISINOPRIL TABLET [BLENHEIM PHARMACAL, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-585LISINOPRIL TABLET [BLENHEIM PHARMACAL, INC.]2Legacy NDC, 1 package rows20150309_a1106697-db02-4e59-a60d-555edbf3dd6f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311353lisinopril 2.5 MG Oral TabletPSNa1106697-db02-4e59-a60d-555edbf3dd6f2
311354lisinopril 5 MG Oral TabletPSNa1106697-db02-4e59-a60d-555edbf3dd6f2
311353lisinopril 2.5 MG Oral TabletSCDa1106697-db02-4e59-a60d-555edbf3dd6f2
311354lisinopril 5 MG Oral TabletSCDa1106697-db02-4e59-a60d-555edbf3dd6f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-585-301054405853030 in 1 BOTTLEHistorical