FDA.reportPublic FDA data

Lisinopril

Product NDC
0591-0409
11-digit product format
005910409
Labeler code
0591
Product ID
0591-0409_01764c1d-aebe-4a46-920c-4b5f8cca8acb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA076059
Marketing category
ANDA
Marketing start
2002-07-01
Substance
LISINOPRIL
Active strength
40 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
LISINOPRIL40 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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-0409-01Lisinopril100 in 1 BOTTLE, PLASTICTABLET10035
0591-0409-05Lisinopril500 in 1 BOTTLE, PLASTICTABLET50035

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-0409-01EA - Each0591-0409947b719d-9e76-4405-bb7e-33726ffaaca012012-07-24
0591-0409-05EA - Each0591-0409275ab169-1fd7-4cda-a554-4088118863fe12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LISINOPRILACTIVE INGREDIENTE7199S1YWRLISINOPRIL TABLET [WATSON LABORATORIES, INC.]20
LISINOPRIL ANHYDROUSACTIVE MOIETY7Q3P4BS2FDLISINOPRIL TABLET [WATSON LABORATORIES, INC.]20
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933LISINOPRIL TABLET [WATSON LABORATORIES, INC.]20
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPLISINOPRIL TABLET [WATSON LABORATORIES, INC.]20
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLISINOPRIL TABLET [WATSON LABORATORIES, INC.]20
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MLISINOPRIL TABLET [WATSON LABORATORIES, INC.]20
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LISINOPRIL TABLET [WATSON LABORATORIES, INC.]20
MANNITOLINACTIVE INGREDIENT3OWL53L36ALISINOPRIL TABLET [WATSON LABORATORIES, INC.]20
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LISINOPRIL TABLET [WATSON LABORATORIES, INC.]20
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLISINOPRIL TABLET [WATSON LABORATORIES, INC.]20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-0409LISINOPRIL TABLET [ACTAVIS PHARMA, INC.]35Current NDC, Legacy NDC, 2 package rows20230913_43e2c8d1-3704-4323-bcaf-f582572b81f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314076lisinopril 10 MG Oral TabletPSN43e2c8d1-3704-4323-bcaf-f582572b81f735
311353lisinopril 2.5 MG Oral TabletPSN43e2c8d1-3704-4323-bcaf-f582572b81f735
314077lisinopril 20 MG Oral TabletPSN43e2c8d1-3704-4323-bcaf-f582572b81f735
205326lisinopril 30 MG Oral TabletPSN43e2c8d1-3704-4323-bcaf-f582572b81f735
197884lisinopril 40 MG Oral TabletPSN43e2c8d1-3704-4323-bcaf-f582572b81f735
311354lisinopril 5 MG Oral TabletPSN43e2c8d1-3704-4323-bcaf-f582572b81f735
314076lisinopril 10 MG Oral TabletSCD43e2c8d1-3704-4323-bcaf-f582572b81f735
311353lisinopril 2.5 MG Oral TabletSCD43e2c8d1-3704-4323-bcaf-f582572b81f735
314077lisinopril 20 MG Oral TabletSCD43e2c8d1-3704-4323-bcaf-f582572b81f735
205326lisinopril 30 MG Oral TabletSCD43e2c8d1-3704-4323-bcaf-f582572b81f735
197884lisinopril 40 MG Oral TabletSCD43e2c8d1-3704-4323-bcaf-f582572b81f735
311354lisinopril 5 MG Oral TabletSCD43e2c8d1-3704-4323-bcaf-f582572b81f735
314076lisinopril 10 MG Oral TabletPSNb17cd16b-8d0a-4cfa-bd48-2529983fcd126
314077lisinopril 20 MG Oral TabletPSNb17cd16b-8d0a-4cfa-bd48-2529983fcd126
197884lisinopril 40 MG Oral TabletPSNb17cd16b-8d0a-4cfa-bd48-2529983fcd126
314076lisinopril 10 MG Oral TabletSCDb17cd16b-8d0a-4cfa-bd48-2529983fcd126
314077lisinopril 20 MG Oral TabletSCDb17cd16b-8d0a-4cfa-bd48-2529983fcd126
197884lisinopril 40 MG Oral TabletSCDb17cd16b-8d0a-4cfa-bd48-2529983fcd126

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-0409-000059104090025000 TABLET in 1 BOX (0591-0409-00)25000 tablet01-JUL-02Current
0591-0409-0100591040901100 TABLET in 1 BOTTLE, PLASTIC (0591-0409-01) 100 tablet2002-07-010000-00-00NoNoCurrent
0591-0409-0500591040905500 TABLET in 1 BOTTLE, PLASTIC (0591-0409-05) 500 tablet2002-07-010000-00-00NoNoCurrent