FDA.reportPublic FDA data

LISINOPRIL

Product NDC
67296-1202
11-digit product format
672961202
Labeler code
67296
Product ID
67296-1202_490debf7-a097-8582-e063-6394a90a851e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LISINOPRIL
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA076164
Marketing category
ANDA
Marketing start
2011-11-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LISINOPRIL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LISINOPRIL20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiE7199S1YWR
Rxcui314077

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
67296-1202-32024-01-30C16284748780-11030e365-20b9-111a-e063-dadaa90a10e24f08cfc9-7afc-33aa-e054-00144ff88e88
67296-1202-92024-01-30C16284748780-11030e365-20b9-111a-e063-dadaa90a10e24f08cfc9-7afc-33aa-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1202-3LISINOPRIL30 in 1 BOTTLETABLET305
67296-1202-9LISINOPRIL90 in 1 BOTTLETABLET905
67296-1202-1LISINOPRIL30 in 1 BOTTLETABLET302
67296-1202-2LISINOPRIL90 in 1 BOTTLETABLET902
67296-1202-6LISINOPRIL60 in 1 BOTTLETABLET602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1202LISINOPRIL TABLET [REDPHARM DRUG, INC.]3Current NDC, Legacy NDC, 2 package rows20220121_4f08cfc9-7afc-33aa-e054-00144ff88e88.zip
67296-1202LISINOPRIL TABLET [REDPHARM DRUG, INC.]2Current NDC, Legacy NDC, 3 package rows20240716_09d2fe2f-73b9-924c-e063-6394a90a9c44.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314077lisinopril 20 MG Oral TabletPSN4f08cfc9-7afc-33aa-e054-00144ff88e885
314077lisinopril 20 MG Oral TabletSCD4f08cfc9-7afc-33aa-e054-00144ff88e885
314077lisinopril 20 MG Oral TabletPSN09d2fe2f-73b9-924c-e063-6394a90a9c442
314077lisinopril 20 MG Oral TabletSCD09d2fe2f-73b9-924c-e063-6394a90a9c442

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1202-16729612020130 in 1 BOTTLEHistorical
67296-1202-26729612020290 in 1 BOTTLEHistorical
67296-1202-36729612020330 TABLET in 1 BOTTLE (67296-1202-3) 30 tablet2011-11-010000-00-00NoNoCurrent
67296-1202-66729612020660 in 1 BOTTLEHistorical
67296-1202-96729612020990 TABLET in 1 BOTTLE (67296-1202-9) 90 tablet2011-11-010000-00-00NoNoCurrent