FDA.reportPublic FDA data

LISINOPRIL

Product NDC
43547-351
11-digit product format
435470351
Labeler code
43547
Product ID
43547-351_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
2.5 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
LISINOPRIL2.5 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
43547-351-03LISINOPRIL30 in 1 BOTTLETABLET307
43547-351-10LISINOPRIL100 in 1 BOTTLETABLET1007
43547-351-50LISINOPRIL500 in 1 BOTTLETABLET5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-351-10EA - Each43547-351a707851a-711b-48e2-a713-589b1726c93512015-03-03
43547-351-50EA - Each43547-35171906e1d-215c-457c-bf15-6581ff31808a12015-03-03

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
43547-351LISINOPRIL 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
311353lisinopril 2.5 MG Oral TabletPSN24f532f2-c41e-4d1d-989e-7a56b60fbdd4102
311353lisinopril 2.5 MG Oral TabletSCD24f532f2-c41e-4d1d-989e-7a56b60fbdd4102
311353lisinopril 2.5 MG Oral TabletPSN11a83bbc-9871-4df8-b3f2-7aba5149f3fe27
205326lisinopril 30 MG Oral TabletPSN11a83bbc-9871-4df8-b3f2-7aba5149f3fe27
311353lisinopril 2.5 MG Oral TabletSCD11a83bbc-9871-4df8-b3f2-7aba5149f3fe27
205326lisinopril 30 MG Oral TabletSCD11a83bbc-9871-4df8-b3f2-7aba5149f3fe27
311353lisinopril 2.5 MG Oral TabletPSN74415f95-74c9-4329-a6af-a0f165bf788711
311353lisinopril 2.5 MG Oral TabletSCD74415f95-74c9-4329-a6af-a0f165bf788711
311353lisinopril 2.5 MG Oral TabletPSN705582ed-da8c-418f-8bb2-fc0b74ed0a8810
311353lisinopril 2.5 MG Oral TabletSCD705582ed-da8c-418f-8bb2-fc0b74ed0a8810
311353lisinopril 2.5 MG Oral TabletPSN42f49299-7ae5-4d30-86eb-66b739c0e95d9
311353lisinopril 2.5 MG Oral TabletSCD42f49299-7ae5-4d30-86eb-66b739c0e95d9
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
311353lisinopril 2.5 MG Oral TabletPSN4f1f76fe-816c-384a-e054-00144ff88e886
311353lisinopril 2.5 MG Oral TabletSCD4f1f76fe-816c-384a-e054-00144ff88e886
311353lisinopril 2.5 MG Oral TabletPSNeddec313-910c-4bf1-9095-2153db53bc6e4
311353lisinopril 2.5 MG Oral TabletPSNdb98aaba-5925-f81b-e053-2a95a90a48794
311353lisinopril 2.5 MG Oral TabletPSNbd804d65-742a-4890-ac9d-bee69968387d4
311353lisinopril 2.5 MG Oral TabletSCDbd804d65-742a-4890-ac9d-bee69968387d4
311353lisinopril 2.5 MG Oral TabletSCDeddec313-910c-4bf1-9095-2153db53bc6e4
311353lisinopril 2.5 MG Oral TabletSCDdb98aaba-5925-f81b-e053-2a95a90a48794
311353lisinopril 2.5 MG Oral TabletPSN9148529f-6278-e507-e053-2995a90aa4cf3
311353lisinopril 2.5 MG Oral TabletSCD9148529f-6278-e507-e053-2995a90aa4cf3
314076lisinopril 10 MG Oral TabletPSNdb5bfa2f-07b8-4f79-8a40-691da006e2ed1
311353lisinopril 2.5 MG Oral TabletPSNdb5bfa2f-07b8-4f79-8a40-691da006e2ed1
311353lisinopril 2.5 MG Oral TabletPSN530f4ab6-a03b-4775-943a-62cb71b7a6451
311353lisinopril 2.5 MG Oral TabletPSN7ea80b2f-1cfa-0eff-e053-2a91aa0ac86e1
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 TabletSCDdb5bfa2f-07b8-4f79-8a40-691da006e2ed1
311353lisinopril 2.5 MG Oral TabletSCD530f4ab6-a03b-4775-943a-62cb71b7a6451
311353lisinopril 2.5 MG Oral TabletSCDdb5bfa2f-07b8-4f79-8a40-691da006e2ed1
311353lisinopril 2.5 MG Oral TabletSCD7ea80b2f-1cfa-0eff-e053-2a91aa0ac86e1
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
43547-351-034354703510330 TABLET in 1 BOTTLE (43547-351-03) 30 tablet2011-11-010000-00-00NoNoCurrent
43547-351-1043547035110100 TABLET in 1 BOTTLE (43547-351-10) 100 tablet2011-11-010000-00-00NoNoCurrent
43547-351-5043547035150500 TABLET in 1 BOTTLE (43547-351-50) 500 tablet2011-11-010000-00-00NoNoCurrent