FDA.reportPublic FDA data

Lisinopril

Product NDC
68180-981
11-digit product format
681800981
Labeler code
68180
Product ID
68180-981_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
2017-05-12
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
68180-981-01Lisinopril100 in 1 BOTTLETABLET10023
68180-981-02Lisinopril500 in 1 BOTTLETABLET50023
68180-981-03Lisinopril1000 in 1 BOTTLETABLET100023
68180-981-05Lisinopril5000 in 1 BOTTLETABLET500023
68180-981-09Lisinopril90 in 1 BOTTLETABLET9023
68180-981-30Lisinopril5000 in 1 POUCHTABLET500023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-981-01EA - Each68180-9812bb79b25-d852-475e-9c4b-809f7df5148812017-04-05
68180-981-03EA - Each68180-9814d79bd0f-8fa2-4dcb-8a6b-adb3cb70540f12017-04-05
68180-981-30EA - Each68180-9813deae1f9-a514-46e8-ab39-122ed64b777412019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-981LISINOPRIL 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
314077lisinopril 20 MG Oral TabletPSNefc9eb3c-0f54-47b8-b236-8680e0046ea424
314077lisinopril 20 MG Oral TabletSCDefc9eb3c-0f54-47b8-b236-8680e0046ea424
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 TabletPSN9470b102-3c81-469a-a4c5-6816d9d39b0723
314077lisinopril 20 MG Oral TabletPSN7d6c31e2-b5a4-4279-8013-a8dad37ea73b23
314077lisinopril 20 MG Oral TabletPSN43fa9a16-c112-419f-8d7b-177f580462f223
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 TabletSCD43fa9a16-c112-419f-8d7b-177f580462f223
314076lisinopril 10 MG Oral TabletSCD7d6c31e2-b5a4-4279-8013-a8dad37ea73b23
311353lisinopril 2.5 MG Oral TabletSCD43fa9a16-c112-419f-8d7b-177f580462f223
311353lisinopril 2.5 MG Oral TabletSCD7d6c31e2-b5a4-4279-8013-a8dad37ea73b23
314077lisinopril 20 MG Oral TabletSCD9470b102-3c81-469a-a4c5-6816d9d39b0723
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 TabletSCD43fa9a16-c112-419f-8d7b-177f580462f223
311354lisinopril 5 MG Oral TabletSCD7d6c31e2-b5a4-4279-8013-a8dad37ea73b23
314077lisinopril 20 MG Oral TabletPSN3451292b-7867-4dc2-afaa-da66b401601721
314077lisinopril 20 MG Oral TabletSCD3451292b-7867-4dc2-afaa-da66b401601721
314076lisinopril 10 MG Oral TabletPSNa2f31909-3cda-4580-adfa-e9992d8c088511
314077lisinopril 20 MG Oral TabletPSNa2f31909-3cda-4580-adfa-e9992d8c088511
314076lisinopril 10 MG Oral TabletSCDa2f31909-3cda-4580-adfa-e9992d8c088511
314077lisinopril 20 MG Oral TabletSCDa2f31909-3cda-4580-adfa-e9992d8c088511
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 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
314077lisinopril 20 MG Oral TabletPSN9ba3610b-de5c-fa33-e053-2a95a90acbc55
314077lisinopril 20 MG Oral TabletPSNfbd3bde1-ee64-126f-e053-6394a90a9b6d5
314077lisinopril 20 MG Oral TabletSCD9ba3610b-de5c-fa33-e053-2a95a90acbc55
314077lisinopril 20 MG Oral TabletSCDfbd3bde1-ee64-126f-e053-6394a90a9b6d5
314077lisinopril 20 MG Oral TabletPSNf6f68322-f8a1-9011-e053-6394a90a1d2c4
314077lisinopril 20 MG Oral TabletPSNb2d493bf-f4d8-4941-8c54-2728d769f6ed4
314077lisinopril 20 MG Oral TabletSCDf6f68322-f8a1-9011-e053-6394a90a1d2c4
314077lisinopril 20 MG Oral TabletSCDb2d493bf-f4d8-4941-8c54-2728d769f6ed4
314077lisinopril 20 MG Oral TabletPSNe3b14778-a57e-51d5-e053-2a95a90a9aad3
314077lisinopril 20 MG Oral TabletSCDe3b14778-a57e-51d5-e053-2a95a90a9aad3
314077lisinopril 20 MG Oral TabletPSNf0a98d25-73c8-4242-821f-19a7de50d89c2
314077lisinopril 20 MG Oral TabletPSNfd8ab6d9-f370-4818-91fd-bb841e01cc272
314077lisinopril 20 MG Oral TabletPSNf4232833-c941-716e-e053-2995a90aa8682
314077lisinopril 20 MG Oral TabletPSN40da6ef5-811b-4c66-aa04-48368b919d762
314077lisinopril 20 MG Oral TabletPSN6a3353e9-d0b9-6301-e053-2a91aa0ab7622
314077lisinopril 20 MG Oral TabletSCDf4232833-c941-716e-e053-2995a90aa8682
314077lisinopril 20 MG Oral TabletSCDf0a98d25-73c8-4242-821f-19a7de50d89c2
314077lisinopril 20 MG Oral TabletSCD6a3353e9-d0b9-6301-e053-2a91aa0ab7622
314077lisinopril 20 MG Oral TabletSCD40da6ef5-811b-4c66-aa04-48368b919d762
314077lisinopril 20 MG Oral TabletSCDfd8ab6d9-f370-4818-91fd-bb841e01cc272
314077lisinopril 20 MG Oral TabletPSN518a63e3-8ca1-bbd1-e063-6294a90aa5241
314077lisinopril 20 MG Oral TabletSCD518a63e3-8ca1-bbd1-e063-6294a90aa5241

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-981-0168180098101100 TABLET in 1 BOTTLE (68180-981-01) 100 tablet2017-05-120000-00-00NoNoCurrent
68180-981-0268180098102500 TABLET in 1 BOTTLE (68180-981-02) 500 tablet2017-05-120000-00-00NoNoCurrent
68180-981-03681800981031000 TABLET in 1 BOTTLE (68180-981-03) 1000 tablet2017-05-120000-00-00NoNoCurrent
68180-981-05681800981055000 TABLET in 1 BOTTLE (68180-981-05) 5000 tablet2017-05-120000-00-00NoNoCurrent
68180-981-096818009810990 TABLET in 1 BOTTLE (68180-981-09) 90 tablet2017-05-120000-00-00NoNoCurrent
68180-981-30681800981305000 TABLET in 1 POUCH (68180-981-30) 5000 tablet2017-05-120000-00-00NoNoCurrent