FDA.reportPublic FDA data

Fosinopril sodium

Product NDC
67544-431
11-digit product format
675440431
Labeler code
67544
Product ID
67544-431_da02b76d-00ea-4733-aef8-7808b0b45d47
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fosinopril sodium
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA077222
Marketing category
ANDA
Marketing start
2005-06-21
Marketing end
0000-00-00
Substance
FOSINOPRIL SODIUM
Active strength
20 mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
90aa3f6a-97f0-be7e-d25b-b26d56ae287eProduct name320201015

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67544-431-152020-01-31C16284748780-19d75b9d0-7369-f424-e053-dadaa90a57ceRx only
67544-431-302020-01-31C16284748780-19d75b9d0-7369-f424-e053-dadaa90a57ceRx only
67544-431-452020-01-31C16284748780-19d75b9d0-7369-f424-e053-dadaa90a57ceRx only
67544-431-532020-01-31C16284748780-19d75b9d0-7369-f424-e053-dadaa90a57ceRx only
67544-431-602020-01-31C16284748780-19d75b9d0-7369-f424-e053-dadaa90a57ceRx only
67544-431-702020-01-31C16284748780-19d75b9d0-7369-f424-e053-dadaa90a57ceRx only
67544-431-732020-01-31C16284748780-19d75b9d0-7369-f424-e053-dadaa90a57ceRx only
67544-431-802020-01-31C16284748780-19d75b9d0-7369-f424-e053-dadaa90a57ceRx only
67544-431-922020-01-31C16284748780-19d75b9d0-7369-f424-e053-dadaa90a57ceRx only
67544-431-942020-01-31C16284748780-19d75b9d0-7369-f424-e053-dadaa90a57ceRx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67544-431-15Fosinopril sodium15 in 1 BOTTLE, PLASTICTABLET152
67544-431-30Fosinopril sodium30 in 1 BOTTLE, PLASTICTABLET302
67544-431-45Fosinopril sodium45 in 1 BOTTLE, PLASTICTABLET452
67544-431-53Fosinopril sodium60 in 1 BOTTLE, PLASTICTABLET602
67544-431-60Fosinopril sodium90 in 1 BOTTLE, PLASTICTABLET902
67544-431-70Fosinopril sodium120 in 1 BOTTLE, PLASTICTABLET1202
67544-431-73Fosinopril sodium135 in 1 BOTTLE, PLASTICTABLET1352
67544-431-80Fosinopril sodium180 in 1 BOTTLE, PLASTICTABLET1802
67544-431-92Fosinopril sodium270 in 1 BOTTLE, PLASTICTABLET2702
67544-431-94Fosinopril sodium360 in 1 BOTTLE, PLASTICTABLET3602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67544-431-15EA - Each67544-43158ac496d-2b88-4807-be23-fd331423574c12014-07-02
67544-431-30EA - Each67544-431f5309689-fafb-4692-ad15-86c73ce0049812014-08-01
67544-431-45EA - Each67544-431163ca1cb-4ef4-41fd-99c0-1a73e0e22a0412014-08-01
67544-431-53EA - Each67544-431b426c7b2-d539-4a21-b170-63824a7df95a12014-08-01
67544-431-60EA - Each67544-431c6c93bd7-e4b3-4d54-89c9-0347c031256f12014-08-01
67544-431-70EA - Each67544-431ec1948a7-bb77-4e28-8d0c-3b99ba0981aa12014-08-01
67544-431-73EA - Each67544-431f35b2a46-434a-40aa-a0d0-75fbb4cfcb1e12014-08-01
67544-431-80EA - Each67544-4312e4f1d72-e40a-4854-aa1e-ead788172a6a12014-08-01
67544-431-92EA - Each67544-431732a2b8e-df9a-4992-956a-0cf10c2364b512014-08-01
67544-431-94EA - Each67544-431e1d472b8-391b-434a-9442-da1fcefff07512014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FOSINOPRIL SODIUMACTIVE INGREDIENTNW2RTH6T2NFOSINOPRIL SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FOSINOPRILATACTIVE MOIETYS312EY6ZT8FOSINOPRIL SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFOSINOPRIL SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKFOSINOPRIL SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GFOSINOPRIL SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FOSINOPRIL SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EFOSINOPRIL SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67544-431FOSINOPRIL SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 10 package rows20140717_0524fc86-caae-4d95-8a65-551ce99637e8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857183fosinopril sodium 20 MG Oral TabletPSN0524fc86-caae-4d95-8a65-551ce99637e82
857183fosinopril sodium 20 MG Oral TabletSCD0524fc86-caae-4d95-8a65-551ce99637e82
857183FNP Sodium 20 MG Oral TabletSY0524fc86-caae-4d95-8a65-551ce99637e82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67544-431-156754404311515 in 1 BOTTLE, PLASTICHistorical
67544-431-306754404313030 in 1 BOTTLE, PLASTICHistorical
67544-431-456754404314545 in 1 BOTTLE, PLASTICHistorical
67544-431-536754404315360 in 1 BOTTLE, PLASTICHistorical
67544-431-606754404316090 in 1 BOTTLE, PLASTICHistorical
67544-431-7067544043170120 in 1 BOTTLE, PLASTICHistorical
67544-431-7367544043173135 in 1 BOTTLE, PLASTICHistorical
67544-431-8067544043180180 in 1 BOTTLE, PLASTICHistorical
67544-431-9267544043192270 in 1 BOTTLE, PLASTICHistorical
67544-431-9467544043194360 in 1 BOTTLE, PLASTICHistorical