FDA.reportPublic FDA data

Lisinopril

Product NDC
64679-953
11-digit product format
646790953
Labeler code
64679
Product ID
64679-953_b760b89e-02b4-8439-e053-2a95a90a9de6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
Wockhardt USA LLC.
Application
ANDA078402
Marketing category
ANDA
Marketing start
2007-04-19
Marketing end
0000-00-00
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
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64679-953-012025-12-23C16284748780-1f386c64a-349a-0266-e053-dadaa90a7c1ae927801e-5de4-44f9-b543-789c093de655
64679-953-022025-12-23C16284748780-1f386c64a-349a-0266-e053-dadaa90a7c1ae927801e-5de4-44f9-b543-789c093de655
64679-953-032025-12-23C16284748780-1f386c64a-349a-0266-e053-dadaa90a7c1ae927801e-5de4-44f9-b543-789c093de655
64679-953-052025-12-23C16284748780-1f386c64a-349a-0266-e053-dadaa90a7c1ae927801e-5de4-44f9-b543-789c093de655
64679-953-012023-01-30C16284748780-1f386c64a-349a-0266-e053-dadaa90a7c1ae927801e-5de4-44f9-b543-789c093de655
64679-953-022023-01-30C16284748780-1f386c64a-349a-0266-e053-dadaa90a7c1ae927801e-5de4-44f9-b543-789c093de655
64679-953-032023-01-30C16284748780-1f386c64a-349a-0266-e053-dadaa90a7c1ae927801e-5de4-44f9-b543-789c093de655
64679-953-052023-01-30C16284748780-1f386c64a-349a-0266-e053-dadaa90a7c1ae927801e-5de4-44f9-b543-789c093de655

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64679-953-01EA - Each64679-95351a2392c-bb2d-44ba-9b32-ea5b49ed7f4612012-07-24
64679-953-02EA - Each64679-953bdbfeea6-9c7d-497a-9d5a-a8635d3d8d8212012-07-24
64679-953-05EA - Each64679-95332f0cdab-66d0-4d4b-aa0b-3d282cb9320312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LISINOPRILACTIVE INGREDIENTE7199S1YWRLISINOPRIL TABLET [WOCKHARDT USA LLC.]1
LISINOPRILACTIVE MOIETYE7199S1YWRLISINOPRIL TABLET [WOCKHARDT USA LLC.]1
BROWN IRON OXIDEINACTIVE INGREDIENT1N032N7MFOLISINOPRIL TABLET [WOCKHARDT USA LLC.]1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPLISINOPRIL TABLET [WOCKHARDT USA LLC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LISINOPRIL TABLET [WOCKHARDT USA LLC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLISINOPRIL TABLET [WOCKHARDT USA LLC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LISINOPRIL TABLET [WOCKHARDT USA LLC.]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ALISINOPRIL TABLET [WOCKHARDT USA LLC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ELISINOPRIL TABLET [WOCKHARDT USA LLC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LISINOPRIL TABLET [WOCKHARDT USA LLC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLISINOPRIL TABLET [WOCKHARDT USA LLC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64679-953LISINOPRIL TABLET [WOCKHARDT USA LLC.]5Legacy NDC20201227_e927801e-5de4-44f9-b543-789c093de655.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64679-953-0164679095301100 TABLET in 1 BOTTLE (64679-953-01) 100 tablet2007-04-190000-00-00NoNoCurrent
64679-953-02646790953021000 TABLET in 1 BOTTLE (64679-953-02) 1000 tablet2007-04-190000-00-00NoNoCurrent
64679-953-036467909530310 BLISTER PACK in 1 CARTON (64679-953-03) > 10 TABLET in 1 BLISTER PACK10 blister pack2007-04-190000-00-00NoNoCurrent
64679-953-0564679095305500 TABLET in 1 BOTTLE (64679-953-05) 500 tablet2007-04-190000-00-00NoNoCurrent