FDA.reportPublic FDA data

lisinopril

Product NDC
70882-103
11-digit product format
708820103
Labeler code
70882
Product ID
70882-103_84eceb98-cd51-4392-b808-371bb0bc420d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
Cambridge Therapeutics Technologies, LLC
Application
ANDA075994
Marketing category
ANDA
Marketing start
2015-05-23
Marketing end
0000-00-00
Substance
LISINOPRIL
Active strength
20 mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
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
70882-103-302026-01-29C16284748780-149896155-b4f0-586f-e063-e6dba90add90These 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
70882-103-30lisinopril30 in 1 BLISTER PACKTABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70882-103-30EA - Each70882-103cf38c634-9692-40c8-a09a-ced2b54559e812017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70882-103LISINOPRIL TABLET LISINOPRIL TABLET [CAMBRIDGE THERAPEUTICS TECHNOLOGIES, LLC]2Legacy NDC, 1 package rows20170227_585f3757-7978-4887-bda9-d072be286482.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314076lisinopril 10 MG Oral TabletPSN585f3757-7978-4887-bda9-d072be2864822
314077lisinopril 20 MG Oral TabletPSN585f3757-7978-4887-bda9-d072be2864822
311354lisinopril 5 MG Oral TabletPSN585f3757-7978-4887-bda9-d072be2864822
314076lisinopril 10 MG Oral TabletSCD585f3757-7978-4887-bda9-d072be2864822
314077lisinopril 20 MG Oral TabletSCD585f3757-7978-4887-bda9-d072be2864822
311354lisinopril 5 MG Oral TabletSCD585f3757-7978-4887-bda9-d072be2864822

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70882-103-307088201033030 TABLET in 1 BLISTER PACK (70882-103-30) 30 tablet2015-05-230000-00-00NoNoCurrent