FDA.reportPublic FDA data

LISINOPRIL

Product NDC
43547-355
11-digit product format
435470355
Labeler code
43547
Product ID
43547-355_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
30 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
LISINOPRIL30 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
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
1199f4b7-b537-466c-9a1c-cb09131e9f8bProduct name120251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
f8f05a6d-f74b-4e9e-ab1c-374d3b4fb820Product name120230703
162cbc9d-ecc3-72ba-af9f-c76e2756ef54Product name320221207
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110
f65307a7-3644-0a09-cdfd-94aae8d3b53eProduct name320210902
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
89a57420-ab44-5323-14f9-595159145f9bProduct name220190612
c27b049d-3258-48cf-ebe5-08c236ae78e2Product name320190610
00fc2cf9-672f-3e0b-6afa-43cbc864d058Product name420180613
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
ea069444-e874-4c28-833f-d2f52734ef4dProduct name120150206
041df61b-f8b6-48a6-7b67-411e1412678bProduct name120140508
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508
433a3439-b8f3-d13a-d2c8-9b221d628d60Product name120140508
59212689-39e5-a976-6d21-882d76d8079aProduct name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
df89bd47-2db4-d593-ab37-d11953fd5536Product name120140508
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43547-355-03LISINOPRIL30 in 1 BOTTLETABLET307
43547-355-10LISINOPRIL100 in 1 BOTTLETABLET1007
43547-355-11LISINOPRIL1000 in 1 BOTTLETABLET10007
43547-355-50LISINOPRIL500 in 1 BOTTLETABLET5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-355-10EA - Each43547-355738a6332-2cae-4f89-b911-61d8a901b05012015-03-03
43547-355-50EA - Each43547-3559ae7f264-ed73-4f6a-abcf-deba01a2eea012015-06-09

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
43547-355LISINOPRIL TABLET [SOLCO HEALTHCARE U.S., LLC]7Current NDC, Legacy NDC, 4 package rows20250403_e299d477-a612-4af4-b6aa-f5addc8a736d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205326lisinopril 30 MG Oral TabletPSNbebf037f-10f8-4e1f-a512-614f81deb891102
205326lisinopril 30 MG Oral TabletSCDbebf037f-10f8-4e1f-a512-614f81deb891102
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
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
205326lisinopril 30 MG Oral TabletPSN3f6bc45e-448e-47f9-9bc4-991b1c503ddf5
205326lisinopril 30 MG Oral TabletPSN6f7f5697-acb0-ea95-e053-2991aa0ae7c75
205326lisinopril 30 MG Oral TabletSCD3f6bc45e-448e-47f9-9bc4-991b1c503ddf5
205326lisinopril 30 MG Oral TabletSCD6f7f5697-acb0-ea95-e053-2991aa0ae7c75
205326lisinopril 30 MG Oral TabletPSN30c81fac-3b27-41f2-b793-4fb1132928b73
205326lisinopril 30 MG Oral TabletSCD30c81fac-3b27-41f2-b793-4fb1132928b73
197886lisinopril 20 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN80221abf-6e01-c8c2-e053-2a91aa0a82b82
205326lisinopril 30 MG Oral TabletPSN80221abf-6e01-c8c2-e053-2a91aa0a82b82
197886hydrochlorothiazide 12.5 MG / lisinopril 20 MG Oral TabletSCD80221abf-6e01-c8c2-e053-2a91aa0a82b82
205326lisinopril 30 MG Oral TabletSCD80221abf-6e01-c8c2-e053-2a91aa0a82b82
197886HCTZ 12.5 MG / lisinopril 20 MG Oral TabletSY80221abf-6e01-c8c2-e053-2a91aa0a82b82
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 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 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
43547-355-034354703550330 TABLET in 1 BOTTLE (43547-355-03) 30 tablet2011-11-010000-00-00NoNoCurrent
43547-355-1043547035510100 TABLET in 1 BOTTLE (43547-355-10) 100 tablet2011-11-010000-00-00NoNoCurrent
43547-355-11435470355111000 TABLET in 1 BOTTLE (43547-355-11) 1000 tablet2011-11-010000-00-00NoNoCurrent
43547-355-5043547035550500 TABLET in 1 BOTTLE (43547-355-50) 500 tablet2011-11-010000-00-00NoNoCurrent