FDA.reportPublic FDA data

LISINOPRIL

Product NDC
43547-354
11-digit product format
435470354
Labeler code
43547
Product ID
43547-354_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
20 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
LISINOPRIL20 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
43547-354-03LISINOPRIL30 in 1 BOTTLETABLET307
43547-354-10LISINOPRIL100 in 1 BOTTLETABLET1007
43547-354-11LISINOPRIL1000 in 1 BOTTLETABLET10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-354-10EA - Each43547-354c3ecf2c1-c97b-4bc3-a4ad-b7a219c5e7f912015-03-03
43547-354-11EA - Each43547-3549770a469-5453-4034-8c1f-687c9fbc21f012015-03-03

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
43547-354LISINOPRIL 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
314077lisinopril 20 MG Oral TabletPSN06ca101e-4498-4c4e-b455-01915e7ecca020
314077lisinopril 20 MG Oral TabletPSNe4c11545-00da-4675-856a-7e600a2f4bd920
314077lisinopril 20 MG Oral TabletSCD06ca101e-4498-4c4e-b455-01915e7ecca020
314077lisinopril 20 MG Oral TabletSCDe4c11545-00da-4675-856a-7e600a2f4bd920
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
314077lisinopril 20 MG Oral TabletPSNd81deeaf-7e5e-44c5-9348-5923c4e3ccd611
314077lisinopril 20 MG Oral TabletPSN02c23f9c-f3cf-4366-ae1e-56296f1fedf911
314077lisinopril 20 MG Oral TabletSCD02c23f9c-f3cf-4366-ae1e-56296f1fedf911
314077lisinopril 20 MG Oral TabletSCDd81deeaf-7e5e-44c5-9348-5923c4e3ccd611
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
314077lisinopril 20 MG Oral TabletPSN54dc1e7e-6abd-4f6d-8b41-2b2731d51a657
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 TabletSCD54dc1e7e-6abd-4f6d-8b41-2b2731d51a657
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
314077lisinopril 20 MG Oral TabletPSNe17bcc2e-f5ed-4846-95d3-a5479c7fee8d6
314077lisinopril 20 MG Oral TabletPSN06862c94-103d-4b12-8a74-abf52cb423896
314077lisinopril 20 MG Oral TabletSCDe17bcc2e-f5ed-4846-95d3-a5479c7fee8d6
314077lisinopril 20 MG Oral TabletSCD06862c94-103d-4b12-8a74-abf52cb423896
314077lisinopril 20 MG Oral TabletPSN5786b8d9-3818-66a5-e053-2991aa0a70255
314077lisinopril 20 MG Oral TabletPSN4b6dc0d4-4acd-3606-e054-00144ff8d46c5
314077lisinopril 20 MG Oral TabletPSNae2d9df4-29ce-3d07-e053-2995a90ab1845
314077lisinopril 20 MG Oral TabletPSN4f08cfc9-7afc-33aa-e054-00144ff88e885
314077lisinopril 20 MG Oral TabletSCD5786b8d9-3818-66a5-e053-2991aa0a70255
314077lisinopril 20 MG Oral TabletSCDae2d9df4-29ce-3d07-e053-2995a90ab1845
314077lisinopril 20 MG Oral TabletSCD4f08cfc9-7afc-33aa-e054-00144ff88e885
314077lisinopril 20 MG Oral TabletSCD4b6dc0d4-4acd-3606-e054-00144ff8d46c5
314077lisinopril 20 MG Oral TabletPSN5f4c1a62-fb84-8cdc-e053-2a91aa0a671a4
314077lisinopril 20 MG Oral TabletPSNbd436b8b-98a6-584c-e053-2995a90ac15d4
314077lisinopril 20 MG Oral TabletSCD5f4c1a62-fb84-8cdc-e053-2a91aa0a671a4
314077lisinopril 20 MG Oral TabletSCDbd436b8b-98a6-584c-e053-2995a90ac15d4
314077lisinopril 20 MG Oral TabletPSN643de9a3-e28a-3521-e053-2991aa0a71403
314077lisinopril 20 MG Oral TabletSCD643de9a3-e28a-3521-e053-2991aa0a71403
314077lisinopril 20 MG Oral TabletPSN0f4bc9ca-055b-436a-a420-517d25b574382
314077lisinopril 20 MG Oral TabletPSN09d2fe2f-73b9-924c-e063-6394a90a9c442
314077lisinopril 20 MG Oral TabletSCD0f4bc9ca-055b-436a-a420-517d25b574382
314077lisinopril 20 MG Oral TabletSCD09d2fe2f-73b9-924c-e063-6394a90a9c442
314076lisinopril 10 MG Oral TabletPSNdb5bfa2f-07b8-4f79-8a40-691da006e2ed1
311353lisinopril 2.5 MG Oral TabletPSNdb5bfa2f-07b8-4f79-8a40-691da006e2ed1
314077lisinopril 20 MG Oral TabletPSNe9bde230-120d-6b5e-e053-2a95a90a89aa1
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 TabletSCDdb5bfa2f-07b8-4f79-8a40-691da006e2ed1
314077lisinopril 20 MG Oral TabletSCDdb5bfa2f-07b8-4f79-8a40-691da006e2ed1
314077lisinopril 20 MG Oral TabletSCDe9bde230-120d-6b5e-e053-2a95a90a89aa1
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
43547-354-034354703540330 TABLET in 1 BOTTLE (43547-354-03) 30 tablet2011-11-010000-00-00NoNoCurrent
43547-354-1043547035410100 TABLET in 1 BOTTLE (43547-354-10) 100 tablet2011-11-010000-00-00NoNoCurrent
43547-354-11435470354111000 TABLET in 1 BOTTLE (43547-354-11) 1000 tablet2011-11-010000-00-00NoNoCurrent