FDA.reportPublic FDA data

LISINOPRIL

Product NDC
43547-353
11-digit product format
435470353
Labeler code
43547
Product ID
43547-353_61b942b0-3ad3-49d4-8321-c3b01f0d7ce1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
Solco healthcare U.S., LLC
Application
ANDA076164
Marketing category
ANDA
Marketing start
2011-11-01
Substance
LISINOPRIL
Active strength
10 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
LISINOPRIL10 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
43547-353-03LISINOPRIL30 in 1 BOTTLETABLET307
43547-353-10LISINOPRIL100 in 1 BOTTLETABLET1007
43547-353-11LISINOPRIL1000 in 1 BOTTLETABLET10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-353-10EA - Each43547-353852217d3-3f41-4b8e-82e8-8f81c8fd240d12015-03-03
43547-353-11EA - Each43547-353996095eb-bb84-422c-9551-486be97f1c8f12015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LISINOPRILACTIVE INGREDIENTE7199S1YWRLISINOPRIL TABLET [SOLCO HEALTHCARE U.S., LLC]1
LISINOPRIL ANHYDROUSACTIVE MOIETY7Q3P4BS2FDLISINOPRIL TABLET [SOLCO HEALTHCARE U.S., LLC]1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPLISINOPRIL TABLET [SOLCO HEALTHCARE U.S., LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LISINOPRIL TABLET [SOLCO HEALTHCARE U.S., LLC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLISINOPRIL TABLET [SOLCO HEALTHCARE U.S., LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LISINOPRIL TABLET [SOLCO HEALTHCARE U.S., LLC]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ALISINOPRIL TABLET [SOLCO HEALTHCARE U.S., LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LISINOPRIL TABLET [SOLCO HEALTHCARE U.S., LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LISINOPRIL TABLET [SOLCO HEALTHCARE U.S., LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLISINOPRIL TABLET [SOLCO HEALTHCARE U.S., LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-353LISINOPRIL TABLET [SOLCO HEALTHCARE U.S., LLC]7Current NDC, Legacy NDC, 3 package rows20250403_e299d477-a612-4af4-b6aa-f5addc8a736d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314076lisinopril 10 MG Oral TabletPSNbabb75f0-bccc-44e8-955a-6873344ccc21119
314077lisinopril 20 MG Oral TabletPSNbabb75f0-bccc-44e8-955a-6873344ccc21119
314076lisinopril 10 MG Oral TabletSCDbabb75f0-bccc-44e8-955a-6873344ccc21119
314077lisinopril 20 MG Oral TabletSCDbabb75f0-bccc-44e8-955a-6873344ccc21119
314076lisinopril 10 MG Oral TabletPSN37aa2542-de44-401b-a6ff-96d2e07914c7105
314076lisinopril 10 MG Oral TabletSCD37aa2542-de44-401b-a6ff-96d2e07914c7105
314076lisinopril 10 MG Oral TabletPSNe65f2d8c-a4f6-40ba-a85d-8ee7806bd65f18
314077lisinopril 20 MG Oral TabletPSNe65f2d8c-a4f6-40ba-a85d-8ee7806bd65f18
311354lisinopril 5 MG Oral TabletPSNe65f2d8c-a4f6-40ba-a85d-8ee7806bd65f18
314076lisinopril 10 MG Oral TabletSCDe65f2d8c-a4f6-40ba-a85d-8ee7806bd65f18
314077lisinopril 20 MG Oral TabletSCDe65f2d8c-a4f6-40ba-a85d-8ee7806bd65f18
311354lisinopril 5 MG Oral TabletSCDe65f2d8c-a4f6-40ba-a85d-8ee7806bd65f18
314076lisinopril 10 MG Oral TabletPSN03a497fe-fb09-4b2c-8ee0-2019600192b814
314076lisinopril 10 MG Oral TabletPSN9c03eb4a-aa58-44a8-82d4-669c880a6f4514
314077lisinopril 20 MG Oral TabletPSN9c03eb4a-aa58-44a8-82d4-669c880a6f4514
197884lisinopril 40 MG Oral TabletPSN9c03eb4a-aa58-44a8-82d4-669c880a6f4514
311354lisinopril 5 MG Oral TabletPSN9c03eb4a-aa58-44a8-82d4-669c880a6f4514
314076lisinopril 10 MG Oral TabletSCD03a497fe-fb09-4b2c-8ee0-2019600192b814
314076lisinopril 10 MG Oral TabletSCD9c03eb4a-aa58-44a8-82d4-669c880a6f4514
314077lisinopril 20 MG Oral TabletSCD9c03eb4a-aa58-44a8-82d4-669c880a6f4514
197884lisinopril 40 MG Oral TabletSCD9c03eb4a-aa58-44a8-82d4-669c880a6f4514
311354lisinopril 5 MG Oral TabletSCD9c03eb4a-aa58-44a8-82d4-669c880a6f4514
314076lisinopril 10 MG Oral TabletPSN8f63c3e0-0b3f-4a04-a592-2ce10dfda20213
314076lisinopril 10 MG Oral TabletSCD8f63c3e0-0b3f-4a04-a592-2ce10dfda20213
314076lisinopril 10 MG Oral TabletPSNaffd3e43-077e-42e5-a865-c961624bfe9311
314076lisinopril 10 MG Oral TabletSCDaffd3e43-077e-42e5-a865-c961624bfe9311
314076lisinopril 10 MG Oral TabletPSNe299d477-a612-4af4-b6aa-f5addc8a736d7
311353lisinopril 2.5 MG Oral TabletPSNe299d477-a612-4af4-b6aa-f5addc8a736d7
314077lisinopril 20 MG Oral TabletPSNe299d477-a612-4af4-b6aa-f5addc8a736d7
205326lisinopril 30 MG Oral TabletPSNe299d477-a612-4af4-b6aa-f5addc8a736d7
197884lisinopril 40 MG Oral TabletPSNe299d477-a612-4af4-b6aa-f5addc8a736d7
311354lisinopril 5 MG Oral TabletPSNe299d477-a612-4af4-b6aa-f5addc8a736d7
314076lisinopril 10 MG Oral TabletSCDe299d477-a612-4af4-b6aa-f5addc8a736d7
311353lisinopril 2.5 MG Oral TabletSCDe299d477-a612-4af4-b6aa-f5addc8a736d7
314077lisinopril 20 MG Oral TabletSCDe299d477-a612-4af4-b6aa-f5addc8a736d7
205326lisinopril 30 MG Oral TabletSCDe299d477-a612-4af4-b6aa-f5addc8a736d7
197884lisinopril 40 MG Oral TabletSCDe299d477-a612-4af4-b6aa-f5addc8a736d7
311354lisinopril 5 MG Oral TabletSCDe299d477-a612-4af4-b6aa-f5addc8a736d7
314076lisinopril 10 MG Oral TabletPSNc3bcfcae-a9ab-4a57-876d-8749ab6c2cff6
314076lisinopril 10 MG Oral TabletPSN350c6fc9-9774-4d49-9242-19e96944f83b6
314076lisinopril 10 MG Oral TabletPSNae2cdf9b-e71e-8315-e053-2995a90a53106
314076lisinopril 10 MG Oral TabletSCDc3bcfcae-a9ab-4a57-876d-8749ab6c2cff6
314076lisinopril 10 MG Oral TabletSCD350c6fc9-9774-4d49-9242-19e96944f83b6
314076lisinopril 10 MG Oral TabletSCDae2cdf9b-e71e-8315-e053-2995a90a53106
314076lisinopril 10 MG Oral TabletPSN5a1c5b04-b78c-c057-e053-2991aa0aa9165
314076lisinopril 10 MG Oral TabletPSN4f972bfd-fdfa-20a1-e054-00144ff88e885
314076lisinopril 10 MG Oral TabletPSN4aa518e1-d989-1fde-e054-00144ff88e885
314076lisinopril 10 MG Oral TabletPSNb5683ac4-59dc-4772-8bc6-984c698afbeb5
314076lisinopril 10 MG Oral TabletSCDb5683ac4-59dc-4772-8bc6-984c698afbeb5
314076lisinopril 10 MG Oral TabletSCD4f972bfd-fdfa-20a1-e054-00144ff88e885
314076lisinopril 10 MG Oral TabletSCD4aa518e1-d989-1fde-e054-00144ff88e885
314076lisinopril 10 MG Oral TabletSCD5a1c5b04-b78c-c057-e053-2991aa0aa9165
314076lisinopril 10 MG Oral TabletPSN6051cc96-86e0-bd0b-e053-2a91aa0a5dcf4
314076lisinopril 10 MG Oral TabletSCD6051cc96-86e0-bd0b-e053-2a91aa0a5dcf4
314076lisinopril 10 MG Oral TabletPSN7392d321-35ad-7f4f-e053-2991aa0ad43e3
314076lisinopril 10 MG Oral TabletSCD7392d321-35ad-7f4f-e053-2991aa0ad43e3
314076lisinopril 10 MG Oral TabletPSN2dbec080-a266-4317-8d4b-b4046206416e2
314076lisinopril 10 MG Oral TabletPSN912f36d4-8349-1414-e053-2995a90a9d942
314076lisinopril 10 MG Oral TabletSCD912f36d4-8349-1414-e053-2995a90a9d942
314076lisinopril 10 MG Oral TabletSCD2dbec080-a266-4317-8d4b-b4046206416e2
314076lisinopril 10 MG Oral TabletPSNdb5bfa2f-07b8-4f79-8a40-691da006e2ed1
314076lisinopril 10 MG Oral TabletPSN912f0be8-e8a1-80cb-e053-2995a90a449e1
314076lisinopril 10 MG Oral TabletPSN99062133-2593-440e-911e-904195faba431
314076lisinopril 10 MG Oral TabletPSNa0b068b4-1e55-446b-912b-3534e9e6fb751
311353lisinopril 2.5 MG Oral TabletPSNdb5bfa2f-07b8-4f79-8a40-691da006e2ed1
314077lisinopril 20 MG Oral TabletPSNdb5bfa2f-07b8-4f79-8a40-691da006e2ed1
205326lisinopril 30 MG Oral TabletPSNdb5bfa2f-07b8-4f79-8a40-691da006e2ed1
197884lisinopril 40 MG Oral TabletPSNdb5bfa2f-07b8-4f79-8a40-691da006e2ed1
311354lisinopril 5 MG Oral TabletPSNdb5bfa2f-07b8-4f79-8a40-691da006e2ed1
314076lisinopril 10 MG Oral TabletSCDa0b068b4-1e55-446b-912b-3534e9e6fb751
314076lisinopril 10 MG Oral TabletSCD99062133-2593-440e-911e-904195faba431
314076lisinopril 10 MG Oral TabletSCDdb5bfa2f-07b8-4f79-8a40-691da006e2ed1
314076lisinopril 10 MG Oral TabletSCD912f0be8-e8a1-80cb-e053-2995a90a449e1
311353lisinopril 2.5 MG Oral TabletSCDdb5bfa2f-07b8-4f79-8a40-691da006e2ed1
314077lisinopril 20 MG Oral TabletSCDdb5bfa2f-07b8-4f79-8a40-691da006e2ed1
205326lisinopril 30 MG Oral TabletSCDdb5bfa2f-07b8-4f79-8a40-691da006e2ed1
197884lisinopril 40 MG Oral TabletSCDdb5bfa2f-07b8-4f79-8a40-691da006e2ed1
311354lisinopril 5 MG Oral TabletSCDdb5bfa2f-07b8-4f79-8a40-691da006e2ed1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43547-353-034354703530330 TABLET in 1 BOTTLE (43547-353-03) 30 tablet2011-11-010000-00-00NoNoCurrent
43547-353-1043547035310100 TABLET in 1 BOTTLE (43547-353-10) 100 tablet2011-11-010000-00-00NoNoCurrent
43547-353-11435470353111000 TABLET in 1 BOTTLE (43547-353-11) 1000 tablet2011-11-010000-00-00NoNoCurrent