FDA.reportPublic FDA data

Lisinopril

Product NDC
43063-811
11-digit product format
430630811
Labeler code
43063
Product ID
43063-811_415b9940-77ea-a174-e063-6294a90a4cfe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA075743
Marketing category
ANDA
Marketing start
2017-08-30
Substance
LISINOPRIL
Active strength
5 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
LISINOPRIL5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiE7199S1YWR
Rxcui197884, 205326, 311353, 311354, 314076, 314077

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
43063-811-01Lisinopril100 in 1 BOTTLE, PLASTICTABLET10025
43063-811-30Lisinopril30 in 1 BOTTLE, PLASTICTABLET3025
43063-811-90Lisinopril90 in 1 BOTTLE, PLASTICTABLET9025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-811-01EA - Each43063-8119aa3a62c-ad6f-4ee9-a862-0419dbb5d53512018-02-20
43063-811-30EA - Each43063-8118b43f4d9-34d6-4e18-b3ba-8dfdfdd0611b12018-02-20
43063-811-90EA - Each43063-81171ffa597-6830-4ed0-a851-ad4ecb76dfc112018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-811LISINOPRIL TABLET [PD-RX PHARMACEUTICALS, INC.]24Current NDC, Legacy NDC, 3 package rows20241017_b62815f3-77fc-4074-a28a-918ab5cc32db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314076lisinopril 10 MG Oral TabletPSNb62815f3-77fc-4074-a28a-918ab5cc32db25
311353lisinopril 2.5 MG Oral TabletPSNb62815f3-77fc-4074-a28a-918ab5cc32db25
314077lisinopril 20 MG Oral TabletPSNb62815f3-77fc-4074-a28a-918ab5cc32db25
205326lisinopril 30 MG Oral TabletPSNb62815f3-77fc-4074-a28a-918ab5cc32db25
197884lisinopril 40 MG Oral TabletPSNb62815f3-77fc-4074-a28a-918ab5cc32db25
311354lisinopril 5 MG Oral TabletPSNb62815f3-77fc-4074-a28a-918ab5cc32db25
314076lisinopril 10 MG Oral TabletSCDb62815f3-77fc-4074-a28a-918ab5cc32db25
311353lisinopril 2.5 MG Oral TabletSCDb62815f3-77fc-4074-a28a-918ab5cc32db25
314077lisinopril 20 MG Oral TabletSCDb62815f3-77fc-4074-a28a-918ab5cc32db25
205326lisinopril 30 MG Oral TabletSCDb62815f3-77fc-4074-a28a-918ab5cc32db25
197884lisinopril 40 MG Oral TabletSCDb62815f3-77fc-4074-a28a-918ab5cc32db25
311354lisinopril 5 MG Oral TabletSCDb62815f3-77fc-4074-a28a-918ab5cc32db25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-811-0143063081101100 TABLET in 1 BOTTLE, PLASTIC (43063-811-01) 100 tablet2018-01-050000-00-00NoNoCurrent
43063-811-304306308113030 TABLET in 1 BOTTLE, PLASTIC (43063-811-30) 30 tablet2018-01-050000-00-00NoNoCurrent
43063-811-904306308119090 TABLET in 1 BOTTLE, PLASTIC (43063-811-90) 90 tablet2018-01-110000-00-00NoNoCurrent