FDA.reportPublic FDA data

LISINOPRIL

Product NDC
71610-733
11-digit product format
716100733
Labeler code
71610
Product ID
71610-733_f6d2d007-eb94-4227-88d7-76df4b64f6e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LISINOPRIL
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA076102
Marketing category
ANDA
Marketing start
2023-04-07
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LISINOPRIL
Listing expiration
2026-12-31

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
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-733-15LISINOPRIL15 in 1 BOTTLETABLET151
71610-733-30LISINOPRIL30 in 1 BOTTLETABLET301
71610-733-45LISINOPRIL45 in 1 BOTTLETABLET451
71610-733-53LISINOPRIL60 in 1 BOTTLETABLET601
71610-733-60LISINOPRIL90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-733-15EA - Each71610-733d0cf22a3-bcd4-4d7c-8f68-5bf78b69e1b812023-12-05
71610-733-45EA - Each71610-73376b41c6e-9ac7-48c2-944a-24776413b4af12023-12-05
71610-733-53EA - Each71610-733eaf70435-455b-4932-87a1-427f45290a2b12023-12-05
71610-733-60EA - Each71610-733d2259793-3c6c-4c98-8fa9-b3b55a9d9ae312023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-733LISINOPRIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, 5 package rows20230913_719c4db7-ccbe-4779-baa7-a3c461f3aa52.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314077lisinopril 20 MG Oral TabletPSN719c4db7-ccbe-4779-baa7-a3c461f3aa521
314077lisinopril 20 MG Oral TabletSCD719c4db7-ccbe-4779-baa7-a3c461f3aa521

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-733-157161007331515 TABLET in 1 BOTTLE (71610-733-15) 15 tablet2023-09-08NoNoHistorical
71610-733-307161007333030 TABLET in 1 BOTTLE (71610-733-30) 30 tablet2023-09-08NoNoHistorical
71610-733-457161007334545 TABLET in 1 BOTTLE (71610-733-45) 45 tablet2023-09-08NoNoHistorical
71610-733-537161007335360 TABLET in 1 BOTTLE (71610-733-53) 60 tablet2023-09-08NoNoHistorical
71610-733-607161007336090 TABLET in 1 BOTTLE (71610-733-60) 90 tablet2023-09-08NoNoHistorical