FDA.reportPublic FDA data

Lisinopril

Product NDC
62135-643
11-digit product format
621350643
Labeler code
62135
Product ID
62135-643_462a5023-e5a0-692a-e063-6294a90a7236
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA208920
Marketing category
ANDA
Marketing start
2021-03-04
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
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
62135-643-31Lisinopril300 in 1 BOTTLETABLET3003
62135-643-90Lisinopril90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-643LISINOPRIL TABLET [CHARTWELL RX, LLC]2Current NDC, 2 package rows20241013_8824e5e5-ed35-4a95-bfd6-98a2e7c4bbce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314076lisinopril 10 MG Oral TabletPSN8824e5e5-ed35-4a95-bfd6-98a2e7c4bbce3
311353lisinopril 2.5 MG Oral TabletPSN8824e5e5-ed35-4a95-bfd6-98a2e7c4bbce3
314077lisinopril 20 MG Oral TabletPSN8824e5e5-ed35-4a95-bfd6-98a2e7c4bbce3
205326lisinopril 30 MG Oral TabletPSN8824e5e5-ed35-4a95-bfd6-98a2e7c4bbce3
197884lisinopril 40 MG Oral TabletPSN8824e5e5-ed35-4a95-bfd6-98a2e7c4bbce3
311354lisinopril 5 MG Oral TabletPSN8824e5e5-ed35-4a95-bfd6-98a2e7c4bbce3
314076lisinopril 10 MG Oral TabletSCD8824e5e5-ed35-4a95-bfd6-98a2e7c4bbce3
311353lisinopril 2.5 MG Oral TabletSCD8824e5e5-ed35-4a95-bfd6-98a2e7c4bbce3
314077lisinopril 20 MG Oral TabletSCD8824e5e5-ed35-4a95-bfd6-98a2e7c4bbce3
205326lisinopril 30 MG Oral TabletSCD8824e5e5-ed35-4a95-bfd6-98a2e7c4bbce3
197884lisinopril 40 MG Oral TabletSCD8824e5e5-ed35-4a95-bfd6-98a2e7c4bbce3
311354lisinopril 5 MG Oral TabletSCD8824e5e5-ed35-4a95-bfd6-98a2e7c4bbce3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-643-3162135064331300 TABLET in 1 BOTTLE (62135-643-31) 300 tablet2023-06-07NoNoCurrent
62135-643-906213506439090 TABLET in 1 BOTTLE (62135-643-90) 90 tablet2023-06-07NoNoCurrent