FDA.reportPublic FDA data

Lisinopril

Product NDC
68180-517
11-digit product format
681800517
Labeler code
68180
Product ID
68180-517_6723a96d-02f8-40c2-95ec-89a7053a7117
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA077321
Marketing category
ANDA
Marketing start
2006-01-13
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
68180-517-01Lisinopril100 in 1 BOTTLETABLET10023
68180-517-02Lisinopril500 in 1 BOTTLETABLET50023
68180-517-03Lisinopril1000 in 1 BOTTLETABLET100023
68180-517-04Lisinopril2000 in 1 BOTTLETABLET200023
68180-517-09Lisinopril90 in 1 BOTTLETABLET9023
68180-517-30Lisinopril5000 in 1 POUCHTABLET500023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-517-01EA - Each68180-517d732bdd4-716e-46f0-b5af-8bf13c4bc88f12012-07-24
68180-517-03EA - Each68180-517c78d9860-a13d-4c31-8037-97f415badcda12012-07-24
68180-517-09EA - Each68180-5171749accd-a67e-4dcd-bab3-276afd2b268b12012-07-24
68180-517-30EA - Each68180-517cda90eb7-1d5d-4d8d-ad41-f6f9eec35b3212020-03-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LISINOPRILACTIVE INGREDIENTE7199S1YWRLISINOPRIL TABLET [PROFICIENT RX LP]3
LISINOPRIL ANHYDROUSACTIVE MOIETY7Q3P4BS2FDLISINOPRIL TABLET [PROFICIENT RX LP]3
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JLISINOPRIL TABLET [PROFICIENT RX LP]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LISINOPRIL TABLET [PROFICIENT RX LP]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LISINOPRIL TABLET [PROFICIENT RX LP]3
MANNITOLINACTIVE INGREDIENT3OWL53L36ALISINOPRIL TABLET [PROFICIENT RX LP]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LISINOPRIL TABLET [PROFICIENT RX LP]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLISINOPRIL TABLET [PROFICIENT RX LP]3
LISINOPRILACTIVE INGREDIENTE7199S1YWRLISINOPRIL TABLET [AIDAREX PHARMACEUTICALS LLC]1
LISINOPRILACTIVE INGREDIENTE7199S1YWRLISINOPRIL TABLET [BLENHEIM PHARMACAL, INC.]1
LISINOPRILACTIVE MOIETYE7199S1YWRLISINOPRIL TABLET [BLENHEIM PHARMACAL, INC.]1
LISINOPRIL ANHYDROUSACTIVE MOIETY7Q3P4BS2FDLISINOPRIL TABLET [AIDAREX PHARMACEUTICALS LLC]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JLISINOPRIL TABLET [BLENHEIM PHARMACAL, INC.]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JLISINOPRIL TABLET [AIDAREX PHARMACEUTICALS LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LISINOPRIL TABLET [AIDAREX PHARMACEUTICALS LLC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLISINOPRIL TABLET [BLENHEIM PHARMACAL, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLISINOPRIL TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LISINOPRIL TABLET [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LISINOPRIL TABLET [AIDAREX PHARMACEUTICALS LLC]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ALISINOPRIL TABLET [BLENHEIM PHARMACAL, INC.]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ALISINOPRIL TABLET [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LISINOPRIL TABLET [BLENHEIM PHARMACAL, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LISINOPRIL TABLET [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLISINOPRIL TABLET [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLISINOPRIL TABLET [BLENHEIM PHARMACAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-517LISINOPRIL TABLET [LUPIN PHARMACEUTICALS, INC.]21Current NDC, Legacy NDC, 6 package rows20240308_7d6c31e2-b5a4-4279-8013-a8dad37ea73b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314076lisinopril 10 MG Oral TabletPSN43fa9a16-c112-419f-8d7b-177f580462f223
314076lisinopril 10 MG Oral TabletPSN7d6c31e2-b5a4-4279-8013-a8dad37ea73b23
311353lisinopril 2.5 MG Oral TabletPSN43fa9a16-c112-419f-8d7b-177f580462f223
311353lisinopril 2.5 MG Oral TabletPSN7d6c31e2-b5a4-4279-8013-a8dad37ea73b23
314077lisinopril 20 MG Oral TabletPSN43fa9a16-c112-419f-8d7b-177f580462f223
314077lisinopril 20 MG Oral TabletPSN7d6c31e2-b5a4-4279-8013-a8dad37ea73b23
205326lisinopril 30 MG Oral TabletPSN7d6c31e2-b5a4-4279-8013-a8dad37ea73b23
197884lisinopril 40 MG Oral TabletPSN43fa9a16-c112-419f-8d7b-177f580462f223
197884lisinopril 40 MG Oral TabletPSN7d6c31e2-b5a4-4279-8013-a8dad37ea73b23
311354lisinopril 5 MG Oral TabletPSN43fa9a16-c112-419f-8d7b-177f580462f223
311354lisinopril 5 MG Oral TabletPSN7d6c31e2-b5a4-4279-8013-a8dad37ea73b23
314076lisinopril 10 MG Oral TabletSCD7d6c31e2-b5a4-4279-8013-a8dad37ea73b23
314076lisinopril 10 MG Oral TabletSCD43fa9a16-c112-419f-8d7b-177f580462f223
311353lisinopril 2.5 MG Oral TabletSCD43fa9a16-c112-419f-8d7b-177f580462f223
311353lisinopril 2.5 MG Oral TabletSCD7d6c31e2-b5a4-4279-8013-a8dad37ea73b23
314077lisinopril 20 MG Oral TabletSCD7d6c31e2-b5a4-4279-8013-a8dad37ea73b23
314077lisinopril 20 MG Oral TabletSCD43fa9a16-c112-419f-8d7b-177f580462f223
205326lisinopril 30 MG Oral TabletSCD7d6c31e2-b5a4-4279-8013-a8dad37ea73b23
197884lisinopril 40 MG Oral TabletSCD7d6c31e2-b5a4-4279-8013-a8dad37ea73b23
197884lisinopril 40 MG Oral TabletSCD43fa9a16-c112-419f-8d7b-177f580462f223
311354lisinopril 5 MG Oral TabletSCD7d6c31e2-b5a4-4279-8013-a8dad37ea73b23
311354lisinopril 5 MG Oral TabletSCD43fa9a16-c112-419f-8d7b-177f580462f223
314076lisinopril 10 MG Oral TabletPSNd87620e1-1a43-43a2-ab37-b9111ea5c17e6
314076lisinopril 10 MG Oral TabletPSNfaade1f8-f901-40f9-a5a2-2a00e8aa94d16
314077lisinopril 20 MG Oral TabletPSNd87620e1-1a43-43a2-ab37-b9111ea5c17e6
314077lisinopril 20 MG Oral TabletPSNfaade1f8-f901-40f9-a5a2-2a00e8aa94d16
197884lisinopril 40 MG Oral TabletPSNfaade1f8-f901-40f9-a5a2-2a00e8aa94d16
197884lisinopril 40 MG Oral TabletPSNd87620e1-1a43-43a2-ab37-b9111ea5c17e6
311354lisinopril 5 MG Oral TabletPSNfaade1f8-f901-40f9-a5a2-2a00e8aa94d16
314076lisinopril 10 MG Oral TabletSCDfaade1f8-f901-40f9-a5a2-2a00e8aa94d16
314076lisinopril 10 MG Oral TabletSCDd87620e1-1a43-43a2-ab37-b9111ea5c17e6
314077lisinopril 20 MG Oral TabletSCDfaade1f8-f901-40f9-a5a2-2a00e8aa94d16
314077lisinopril 20 MG Oral TabletSCDd87620e1-1a43-43a2-ab37-b9111ea5c17e6
197884lisinopril 40 MG Oral TabletSCDfaade1f8-f901-40f9-a5a2-2a00e8aa94d16
197884lisinopril 40 MG Oral TabletSCDd87620e1-1a43-43a2-ab37-b9111ea5c17e6
311354lisinopril 5 MG Oral TabletSCDfaade1f8-f901-40f9-a5a2-2a00e8aa94d16
314076lisinopril 10 MG Oral TabletPSN6a36526a-face-95b9-e053-2991aa0a53f02
311353lisinopril 2.5 MG Oral TabletPSN6a36526a-face-95b9-e053-2991aa0a53f02
197884lisinopril 40 MG Oral TabletPSN6a36526a-face-95b9-e053-2991aa0a53f02
314076lisinopril 10 MG Oral TabletSCD6a36526a-face-95b9-e053-2991aa0a53f02
311353lisinopril 2.5 MG Oral TabletSCD6a36526a-face-95b9-e053-2991aa0a53f02
197884lisinopril 40 MG Oral TabletSCD6a36526a-face-95b9-e053-2991aa0a53f02
314076lisinopril 10 MG Oral TabletPSNe7fa0480-ed0f-44d8-9d20-4f82ed5350b91
205326lisinopril 30 MG Oral TabletPSNe7fa0480-ed0f-44d8-9d20-4f82ed5350b91
197884lisinopril 40 MG Oral TabletPSNe7fa0480-ed0f-44d8-9d20-4f82ed5350b91
197884lisinopril 40 MG Oral TabletPSNc7d18687-9a6b-4d56-8d16-3830ad17cb8d1
314076lisinopril 10 MG Oral TabletSCDe7fa0480-ed0f-44d8-9d20-4f82ed5350b91
205326lisinopril 30 MG Oral TabletSCDe7fa0480-ed0f-44d8-9d20-4f82ed5350b91
197884lisinopril 40 MG Oral TabletSCDe7fa0480-ed0f-44d8-9d20-4f82ed5350b91
197884lisinopril 40 MG Oral TabletSCDc7d18687-9a6b-4d56-8d16-3830ad17cb8d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-517-0168180051701100 TABLET in 1 BOTTLE (68180-517-01) 100 tablet2006-01-132024-03-31NoNoCurrent
68180-517-0268180051702500 TABLET in 1 BOTTLE (68180-517-02) 500 tablet2006-01-132024-03-31NoNoCurrent
68180-517-03681800517031000 TABLET in 1 BOTTLE (68180-517-03) 1000 tablet2006-01-132024-03-31NoNoCurrent
68180-517-04681800517042000 TABLET in 1 BOTTLE (68180-517-04) 2000 tablet2006-01-132024-03-31NoNoCurrent
68180-517-096818005170990 TABLET in 1 BOTTLE (68180-517-09) 90 tablet2006-01-132024-03-31NoNoCurrent
68180-517-30681800517305000 TABLET in 1 POUCH (68180-517-30) 5000 tablet2006-01-132024-03-31NoNoCurrent