FDA.reportPublic FDA data

LISINOPRIL

Product NDC
43547-352
11-digit product format
435470352
Labeler code
43547
Product ID
43547-352_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
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
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
43547-352-10LISINOPRIL100 in 1 BOTTLETABLET1007
43547-352-11LISINOPRIL1000 in 1 BOTTLETABLET10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-352-10EA - Each43547-3520010f4bd-b89e-40a6-a11b-481d956a60f812015-03-03
43547-352-11EA - Each43547-352881dc70d-6482-4381-aee1-232dd125fda312015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LISINOPRILACTIVE INGREDIENTE7199S1YWRLISINOPRIL TABLET [SOLCO HEALTHCARE U.S., LLC]1
LISINOPRILACTIVE INGREDIENTE7199S1YWRLISINOPRIL TABLET [PROFICIENT RX LP]1
LISINOPRIL ANHYDROUSACTIVE MOIETY7Q3P4BS2FDLISINOPRIL TABLET [PROFICIENT RX LP]1
LISINOPRIL ANHYDROUSACTIVE MOIETY7Q3P4BS2FDLISINOPRIL TABLET [SOLCO HEALTHCARE U.S., LLC]1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPLISINOPRIL TABLET [PROFICIENT RX LP]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
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLISINOPRIL TABLET [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LISINOPRIL TABLET [SOLCO HEALTHCARE U.S., LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LISINOPRIL TABLET [PROFICIENT RX LP]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ALISINOPRIL TABLET [SOLCO HEALTHCARE U.S., LLC]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ALISINOPRIL TABLET [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LISINOPRIL TABLET [PROFICIENT RX LP]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
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LISINOPRIL TABLET [PROFICIENT RX LP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLISINOPRIL TABLET [PROFICIENT RX LP]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
43547-352LISINOPRIL TABLET [SOLCO HEALTHCARE U.S., LLC]7Current NDC, Legacy NDC, 2 package rows20250403_e299d477-a612-4af4-b6aa-f5addc8a736d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311354lisinopril 5 MG Oral TabletPSN0bf433cb-bf7d-4b41-9518-400646f9aa2a102
311354lisinopril 5 MG Oral TabletSCD0bf433cb-bf7d-4b41-9518-400646f9aa2a102
311354lisinopril 5 MG Oral TabletPSN176c744a-d4e3-4a4b-ac62-4fbcb1d8d7bf21
311354lisinopril 5 MG Oral TabletSCD176c744a-d4e3-4a4b-ac62-4fbcb1d8d7bf21
311354lisinopril 5 MG Oral TabletPSNf57bd658-05d8-475a-ae74-87d2c786641720
311354lisinopril 5 MG Oral TabletSCDf57bd658-05d8-475a-ae74-87d2c786641720
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 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 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
311354lisinopril 5 MG Oral TabletPSNbf59ff89-a9fa-4fe3-b167-a5d0cba9e43813
311354lisinopril 5 MG Oral TabletSCDbf59ff89-a9fa-4fe3-b167-a5d0cba9e43813
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 TabletPSN4aa44af9-1aff-314c-e054-00144ff8d46c7
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
311354lisinopril 5 MG Oral TabletSCD4aa44af9-1aff-314c-e054-00144ff8d46c7
311354lisinopril 5 MG Oral TabletPSNdac0c8f1-e3cf-11e6-e053-2a95a90adbcb4
311354lisinopril 5 MG Oral TabletPSNe5fbefd1-4077-4e81-a0e3-e09fadc485934
311354lisinopril 5 MG Oral TabletPSN6062fd98-7663-f4b5-e053-2a91aa0acbc34
311354lisinopril 5 MG Oral TabletSCDe5fbefd1-4077-4e81-a0e3-e09fadc485934
311354lisinopril 5 MG Oral TabletSCD6062fd98-7663-f4b5-e053-2a91aa0acbc34
311354lisinopril 5 MG Oral TabletSCDdac0c8f1-e3cf-11e6-e053-2a95a90adbcb4
311354lisinopril 5 MG Oral TabletPSN86e7a336-c416-6fab-e053-2a91aa0a274c3
311354lisinopril 5 MG Oral TabletPSN91321ca0-f2dd-f66c-e053-2995a90a83423
311354lisinopril 5 MG Oral TabletPSN7e297133-669e-4780-a966-c777624e54273
311354lisinopril 5 MG Oral TabletSCD86e7a336-c416-6fab-e053-2a91aa0a274c3
311354lisinopril 5 MG Oral TabletSCD91321ca0-f2dd-f66c-e053-2995a90a83423
311354lisinopril 5 MG Oral TabletSCD7e297133-669e-4780-a966-c777624e54273
314076lisinopril 10 MG Oral TabletPSNdb5bfa2f-07b8-4f79-8a40-691da006e2ed1
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 TabletPSNab6eef19-0934-aae6-e053-2a95a90ab5731
311354lisinopril 5 MG Oral TabletPSNdb5bfa2f-07b8-4f79-8a40-691da006e2ed1
311354lisinopril 5 MG Oral TabletPSN6ba2c7d6-bc9e-4d8b-8d1e-c140047506931
314076lisinopril 10 MG Oral TabletSCDdb5bfa2f-07b8-4f79-8a40-691da006e2ed1
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 TabletSCDab6eef19-0934-aae6-e053-2a95a90ab5731
311354lisinopril 5 MG Oral TabletSCDdb5bfa2f-07b8-4f79-8a40-691da006e2ed1
311354lisinopril 5 MG Oral TabletSCD6ba2c7d6-bc9e-4d8b-8d1e-c140047506931

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43547-352-1043547035210100 TABLET in 1 BOTTLE (43547-352-10) 100 tablet2011-11-010000-00-00NoNoCurrent
43547-352-11435470352111000 TABLET in 1 BOTTLE (43547-352-11) 1000 tablet2011-11-010000-00-00NoNoCurrent