FDA.reportPublic FDA data

Fosinopril sodium

Product NDC
76282-202
11-digit product format
762820202
Labeler code
76282
Product ID
76282-202_ed121c1b-359c-471e-913c-4afdf9102c34
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fosinopril sodium
Dosage form
TABLET
Route
ORAL
Labeler
Exelan Pharmaceuticals, Inc.
Application
ANDA077222
Marketing category
ANDA
Marketing start
2005-06-21
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fosinopril sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FOSINOPRIL SODIUM40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNW2RTH6T2N
Rxcui857169, 857183, 857187

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
76282-202-102023-03-23C16284748780-1f386c64a-0f04-0266-e053-dadaa90a7c1aRx only
76282-202-902023-03-23C16284748780-1f386c64a-0f04-0266-e053-dadaa90a7c1aRx only
76282-202-102023-01-30C16284748780-1f386c64a-0f04-0266-e053-dadaa90a7c1aRx only
76282-202-902023-01-30C16284748780-1f386c64a-0f04-0266-e053-dadaa90a7c1aRx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76282-202-10Fosinopril sodium1000 in 1 BOTTLETABLET10008
76282-202-90Fosinopril sodium90 in 1 BOTTLETABLET908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-202-10EA - Each76282-202d5e927a0-a721-40bc-a1d4-2e66604150a312012-07-24
76282-202-90EA - Each76282-202d9644026-853c-4fea-a4a8-caf26adbf3c312012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-202FOSINOPRIL SODIUM TABLET [EXELAN PHARMACEUTICALS, INC.]8Current NDC, Legacy NDC, 2 package rows20230324_e2ff3171-a17a-456a-9272-ca1682b01d19.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857169fosinopril sodium 10 MG Oral TabletPSNe2ff3171-a17a-456a-9272-ca1682b01d198
857183fosinopril sodium 20 MG Oral TabletPSNe2ff3171-a17a-456a-9272-ca1682b01d198
857187fosinopril sodium 40 MG Oral TabletPSNe2ff3171-a17a-456a-9272-ca1682b01d198
857169fosinopril sodium 10 MG Oral TabletSCDe2ff3171-a17a-456a-9272-ca1682b01d198
857183fosinopril sodium 20 MG Oral TabletSCDe2ff3171-a17a-456a-9272-ca1682b01d198
857187fosinopril sodium 40 MG Oral TabletSCDe2ff3171-a17a-456a-9272-ca1682b01d198
857169FNP Sodium 10 MG Oral TabletSYe2ff3171-a17a-456a-9272-ca1682b01d198
857183FNP Sodium 20 MG Oral TabletSYe2ff3171-a17a-456a-9272-ca1682b01d198
857187FNP Sodium 40 MG Oral TabletSYe2ff3171-a17a-456a-9272-ca1682b01d198
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
857169fosinopril sodium 10 MG Oral TabletPSN0cef0cd4-e952-40c8-b715-bce4d2f02c511
857187fosinopril sodium 40 MG Oral TabletPSN0cef0cd4-e952-40c8-b715-bce4d2f02c511
857169fosinopril sodium 10 MG Oral TabletSCD0cef0cd4-e952-40c8-b715-bce4d2f02c511
857187fosinopril sodium 40 MG Oral TabletSCD0cef0cd4-e952-40c8-b715-bce4d2f02c511
857169FNP Sodium 10 MG Oral TabletSY0cef0cd4-e952-40c8-b715-bce4d2f02c511
857187FNP Sodium 40 MG Oral TabletSY0cef0cd4-e952-40c8-b715-bce4d2f02c511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76282-202-10762820202101000 TABLET in 1 BOTTLE (76282-202-10) 1000 tablet2005-06-210000-00-00NoNoCurrent
76282-202-907628202029090 TABLET in 1 BOTTLE (76282-202-90) 90 tablet2005-06-210000-00-00NoNoCurrent