FDA.reportPublic FDA data

Lisinopril

Product NDC
68180-513
11-digit product format
681800513
Labeler code
68180
Product ID
68180-513_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
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
LISINOPRIL5 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
68180-513-01Lisinopril100 in 1 BOTTLETABLET10023
68180-513-02Lisinopril500 in 1 BOTTLETABLET50023
68180-513-03Lisinopril1000 in 1 BOTTLETABLET100023
68180-513-05Lisinopril5000 in 1 BOTTLETABLET500023
68180-513-09Lisinopril90 in 1 BOTTLETABLET9023
68180-513-30Lisinopril5000 in 1 POUCHTABLET500023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-513-01EA - Each68180-51369bc3801-104b-42fd-84dc-d54fcde6dfe412012-07-24
68180-513-03EA - Each68180-513b1509642-d878-4882-be7c-23dab54281e412012-07-24
68180-513-09EA - Each68180-513aebbcd7c-840f-4a01-9e52-adafd24950d012012-07-24
68180-513-30EA - Each68180-5135712ad8a-ef5f-4af3-ad9d-4f4059e4b14412022-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LISINOPRILACTIVE INGREDIENTE7199S1YWRLISINOPRIL TABLET [BRYANT RANCH PREPACK]3
LISINOPRILACTIVE INGREDIENTE7199S1YWRLISINOPRIL (LISINOPRIL) TABLET [PD-RX PHARMACEUTICALS, INC.]3
LISINOPRIL ANHYDROUSACTIVE MOIETY7Q3P4BS2FDLISINOPRIL TABLET [BRYANT RANCH PREPACK]3
LISINOPRIL ANHYDROUSACTIVE MOIETY7Q3P4BS2FDLISINOPRIL (LISINOPRIL) TABLET [PD-RX PHARMACEUTICALS, INC.]3
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JLISINOPRIL (LISINOPRIL) TABLET [PD-RX PHARMACEUTICALS, INC.]3
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JLISINOPRIL TABLET [BRYANT RANCH PREPACK]3
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LISINOPRIL (LISINOPRIL) TABLET [PD-RX PHARMACEUTICALS, INC.]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LISINOPRIL TABLET [BRYANT RANCH PREPACK]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LISINOPRIL (LISINOPRIL) TABLET [PD-RX PHARMACEUTICALS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LISINOPRIL TABLET [BRYANT RANCH PREPACK]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LISINOPRIL (LISINOPRIL) TABLET [PD-RX PHARMACEUTICALS, INC.]3
MANNITOLINACTIVE INGREDIENT3OWL53L36ALISINOPRIL TABLET [BRYANT RANCH PREPACK]3
MANNITOLINACTIVE INGREDIENT3OWL53L36ALISINOPRIL (LISINOPRIL) TABLET [PD-RX PHARMACEUTICALS, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LISINOPRIL TABLET [BRYANT RANCH PREPACK]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLISINOPRIL (LISINOPRIL) TABLET [PD-RX PHARMACEUTICALS, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLISINOPRIL TABLET [BRYANT RANCH PREPACK]3
LISINOPRILACTIVE INGREDIENTE7199S1YWRLISINOPRIL TABLET [NORTHWIND PHARMACEUTICALS, LLC]1
LISINOPRIL ANHYDROUSACTIVE MOIETY7Q3P4BS2FDLISINOPRIL TABLET [NORTHWIND PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-513LISINOPRIL 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 TabletPSN7d6c31e2-b5a4-4279-8013-a8dad37ea73b23
311353lisinopril 2.5 MG Oral TabletPSN43fa9a16-c112-419f-8d7b-177f580462f223
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 TabletPSN7d6c31e2-b5a4-4279-8013-a8dad37ea73b23
311354lisinopril 5 MG Oral TabletPSN43fa9a16-c112-419f-8d7b-177f580462f223
314076lisinopril 10 MG Oral TabletSCD7d6c31e2-b5a4-4279-8013-a8dad37ea73b23
314076lisinopril 10 MG Oral TabletSCD43fa9a16-c112-419f-8d7b-177f580462f223
311353lisinopril 2.5 MG Oral TabletSCD7d6c31e2-b5a4-4279-8013-a8dad37ea73b23
311353lisinopril 2.5 MG Oral TabletSCD43fa9a16-c112-419f-8d7b-177f580462f223
314077lisinopril 20 MG Oral TabletSCD43fa9a16-c112-419f-8d7b-177f580462f223
314077lisinopril 20 MG Oral TabletSCD7d6c31e2-b5a4-4279-8013-a8dad37ea73b23
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
311354lisinopril 5 MG Oral TabletPSNa33d860a-1e17-45b7-aede-51ab3223bebd20
311354lisinopril 5 MG Oral TabletSCDa33d860a-1e17-45b7-aede-51ab3223bebd20
311354lisinopril 5 MG Oral TabletPSN59fd2167-4da4-9143-83bd-3b6aa505151119
311354lisinopril 5 MG Oral TabletSCD59fd2167-4da4-9143-83bd-3b6aa505151119
311354lisinopril 5 MG Oral TabletPSNc621c33b-cb67-4ea6-b2bd-96c20a244ea413
311354lisinopril 5 MG Oral TabletSCDc621c33b-cb67-4ea6-b2bd-96c20a244ea413
314076lisinopril 10 MG Oral TabletPSNfaade1f8-f901-40f9-a5a2-2a00e8aa94d16
314077lisinopril 20 MG Oral TabletPSNfaade1f8-f901-40f9-a5a2-2a00e8aa94d16
197884lisinopril 40 MG Oral TabletPSNfaade1f8-f901-40f9-a5a2-2a00e8aa94d16
311354lisinopril 5 MG Oral TabletPSN6515d800-be95-4a70-ab1e-b4000708dd206
311354lisinopril 5 MG Oral TabletPSNfaade1f8-f901-40f9-a5a2-2a00e8aa94d16
314076lisinopril 10 MG Oral TabletSCDfaade1f8-f901-40f9-a5a2-2a00e8aa94d16
314077lisinopril 20 MG Oral TabletSCDfaade1f8-f901-40f9-a5a2-2a00e8aa94d16
197884lisinopril 40 MG Oral TabletSCDfaade1f8-f901-40f9-a5a2-2a00e8aa94d16
311354lisinopril 5 MG Oral TabletSCDfaade1f8-f901-40f9-a5a2-2a00e8aa94d16
311354lisinopril 5 MG Oral TabletSCD6515d800-be95-4a70-ab1e-b4000708dd206
311354lisinopril 5 MG Oral TabletPSN7cd7c59d-ce52-1f5b-e053-2a91aa0a8f865
311354lisinopril 5 MG Oral TabletSCD7cd7c59d-ce52-1f5b-e053-2a91aa0a8f865
311354lisinopril 5 MG Oral TabletPSNc16edad6-423b-6ff0-e053-2a95a90a02404
311354lisinopril 5 MG Oral TabletSCDc16edad6-423b-6ff0-e053-2a95a90a02404
311354lisinopril 5 MG Oral TabletPSN1e782cd9-bcfa-4be8-84ad-069d99af5f1c2
311354lisinopril 5 MG Oral TabletPSN726a6f23-737a-4866-b4ba-b3c18cd2e1ac2
311354lisinopril 5 MG Oral TabletPSN684540e0-d1a7-4aa0-9a28-41d338e9e63f2
311354lisinopril 5 MG Oral TabletSCD726a6f23-737a-4866-b4ba-b3c18cd2e1ac2
311354lisinopril 5 MG Oral TabletSCD1e782cd9-bcfa-4be8-84ad-069d99af5f1c2
311354lisinopril 5 MG Oral TabletSCD684540e0-d1a7-4aa0-9a28-41d338e9e63f2
311354lisinopril 5 MG Oral TabletPSN971a7e3d-0091-4174-a677-a3f49fe86a0e1
311354lisinopril 5 MG Oral TabletPSNbcd14c33-e2c1-85ca-e053-2995a90a4efa1
311354lisinopril 5 MG Oral TabletSCDbcd14c33-e2c1-85ca-e053-2995a90a4efa1
311354lisinopril 5 MG Oral TabletSCD971a7e3d-0091-4174-a677-a3f49fe86a0e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-513-0168180051301100 TABLET in 1 BOTTLE (68180-513-01) 100 tablet2006-01-130000-00-00NoNoCurrent
68180-513-0268180051302500 TABLET in 1 BOTTLE (68180-513-02) 500 tablet2006-01-130000-00-00NoNoCurrent
68180-513-03681800513031000 TABLET in 1 BOTTLE (68180-513-03) 1000 tablet2006-01-130000-00-00NoNoCurrent
68180-513-05681800513055000 TABLET in 1 BOTTLE (68180-513-05) 5000 tablet2006-01-130000-00-00NoNoCurrent
68180-513-096818005130990 TABLET in 1 BOTTLE (68180-513-09) 90 tablet2006-01-130000-00-00NoNoCurrent
68180-513-30681800513305000 TABLET in 1 POUCH (68180-513-30) 5000 tablet2006-01-130000-00-00NoNoCurrent