FDA.reportPublic FDA data

Fosinopril sodium

Product NDC
43353-870
11-digit product format
433530870
Labeler code
43353
Product ID
43353-870_6aaf33c1-90ec-45ad-87fe-603d794a8a0e
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
40 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
43353-870-452020-01-31C16284748780-19d75b9d0-f7d5-f424-e053-dadaa90a57ceRx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-870-45Fosinopril sodium45 in 1 BOTTLE, PLASTICTABLET452

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-870-45EA - Each43353-870aa4d79d4-6aae-4b78-98d9-10b6181a0e9a12015-05-05

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
43353-870FOSINOPRIL SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 1 package rows20140717_41d4f5a7-8477-4f31-834a-29457b33ee41.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857187fosinopril sodium 40 MG Oral TabletPSN41d4f5a7-8477-4f31-834a-29457b33ee412
857187fosinopril sodium 40 MG Oral TabletSCD41d4f5a7-8477-4f31-834a-29457b33ee412
857187FNP Sodium 40 MG Oral TabletSY41d4f5a7-8477-4f31-834a-29457b33ee412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-870-454335308704545 in 1 BOTTLE, PLASTICHistorical