FDA.reportPublic FDA data

LISINOPRIL

Product NDC
43547-356
11-digit product format
435470356
Labeler code
43547
Product ID
43547-356_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
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
43547-356-10LISINOPRIL100 in 1 BOTTLETABLET1007
43547-356-11LISINOPRIL1000 in 1 BOTTLETABLET10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-356-10EA - Each43547-35666477742-18d5-46f2-a20f-d1dc040b1d7412015-03-03
43547-356-11EA - Each43547-356844e297e-b674-4025-9c3c-cc1817c4cdcf12015-03-03

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
43547-356LISINOPRIL 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
197884lisinopril 40 MG Oral TabletPSN1ec55dd0-9ed5-40d2-978e-9fe773f2281a102
197884lisinopril 40 MG Oral TabletSCD1ec55dd0-9ed5-40d2-978e-9fe773f2281a102
197884lisinopril 40 MG Oral TabletPSNd18f2117-0d2a-4e0d-8ffb-130ca690036420
197884lisinopril 40 MG Oral TabletSCDd18f2117-0d2a-4e0d-8ffb-130ca690036420
197884lisinopril 40 MG Oral TabletPSNa881df2d-e3b7-413f-b4bb-2c3d917b081116
197884lisinopril 40 MG Oral TabletSCDa881df2d-e3b7-413f-b4bb-2c3d917b081116
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
197884lisinopril 40 MG Oral TabletPSNdd015c18-1ea6-44e3-9186-8d2f8444d87412
197884lisinopril 40 MG Oral TabletSCDdd015c18-1ea6-44e3-9186-8d2f8444d87412
197884lisinopril 40 MG Oral TabletPSN12d6fe7e-b5a2-4d49-9a06-a6150234d06111
197884lisinopril 40 MG Oral TabletSCD12d6fe7e-b5a2-4d49-9a06-a6150234d06111
197884lisinopril 40 MG Oral TabletPSNab561d21-7466-4d8b-8d06-291c1d4d82ff9
197884lisinopril 40 MG Oral TabletSCDab561d21-7466-4d8b-8d06-291c1d4d82ff9
197884lisinopril 40 MG Oral TabletPSN29e9ac54-f9da-495c-9102-2aac2cc7d88a8
197884lisinopril 40 MG Oral TabletSCD29e9ac54-f9da-495c-9102-2aac2cc7d88a8
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
197884lisinopril 40 MG Oral TabletPSN6314e49c-8715-2f01-e053-2a91aa0ab2a56
197884lisinopril 40 MG Oral TabletPSNcfd31165-5902-4c94-8fff-2940faa983c16
197884lisinopril 40 MG Oral TabletSCD6314e49c-8715-2f01-e053-2a91aa0ab2a56
197884lisinopril 40 MG Oral TabletSCDcfd31165-5902-4c94-8fff-2940faa983c16
197884lisinopril 40 MG Oral TabletPSN51c80515-b26d-5776-e054-00144ff8d46c5
197884lisinopril 40 MG Oral TabletPSNab2f8ab5-3c87-484a-e053-2995a90a42bb5
197884lisinopril 40 MG Oral TabletPSN3e4e69f6-b8a6-462d-a7ec-4cd6636512d05
197884lisinopril 40 MG Oral TabletSCD51c80515-b26d-5776-e054-00144ff8d46c5
197884lisinopril 40 MG Oral TabletSCDab2f8ab5-3c87-484a-e053-2995a90a42bb5
197884lisinopril 40 MG Oral TabletSCD3e4e69f6-b8a6-462d-a7ec-4cd6636512d05
197884lisinopril 40 MG Oral TabletPSN5eff766f-82e2-4cd6-e053-2a91aa0a47824
197884lisinopril 40 MG Oral TabletSCD5eff766f-82e2-4cd6-e053-2a91aa0a47824
197884lisinopril 40 MG Oral TabletPSN9623fcad-f8a3-0f04-e053-2995a90a5a1a2
197884lisinopril 40 MG Oral TabletPSN912eeb2b-020b-6d22-e053-2a95a90afbe62
197884lisinopril 40 MG Oral TabletSCD9623fcad-f8a3-0f04-e053-2995a90a5a1a2
197884lisinopril 40 MG Oral TabletSCD912eeb2b-020b-6d22-e053-2a95a90afbe62
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 TabletPSN507efe06-e0cf-48c4-88e6-8cd2e83a1a241
197884lisinopril 40 MG Oral TabletPSNdb5bfa2f-07b8-4f79-8a40-691da006e2ed1
197884lisinopril 40 MG Oral TabletPSN7f864dbe-4de0-b642-e053-2991aa0afad51
311354lisinopril 5 MG Oral TabletPSNdb5bfa2f-07b8-4f79-8a40-691da006e2ed1
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 TabletSCD507efe06-e0cf-48c4-88e6-8cd2e83a1a241
197884lisinopril 40 MG Oral TabletSCD7f864dbe-4de0-b642-e053-2991aa0afad51
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
43547-356-1043547035610100 TABLET in 1 BOTTLE (43547-356-10) 100 tablet2011-11-010000-00-00NoNoCurrent
43547-356-11435470356111000 TABLET in 1 BOTTLE (43547-356-11) 1000 tablet2011-11-010000-00-00NoNoCurrent