Fosinopril Sodium

Product NDC
65862-472
11-digit product format
658620472
Labeler code
65862
Product ID
65862-472_f6a2e63b-e4fb-46c3-8687-eec210b347c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fosinopril Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA091163
Marketing category
ANDA
Marketing start
2011-03-30
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
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 SODIUM20 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-472-30Fosinopril Sodium30 in 1 BOTTLETABLET308
65862-472-90Fosinopril Sodium90 in 1 BOTTLETABLET908
65862-472-99Fosinopril Sodium1000 in 1 BOTTLETABLET10008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-472-90EA - Each65862-472e03d28a4-7a35-4851-b7b3-ecfaa242995812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FOSINOPRIL SODIUMACTIVE INGREDIENTNW2RTH6T2NFOSINOPRIL SODIUM TABLET [AUROBINDO PHARMA LIMITED]5
FOSINOPRILATACTIVE MOIETYS312EY6ZT8FOSINOPRIL SODIUM TABLET [AUROBINDO PHARMA LIMITED]5
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKFOSINOPRIL SODIUM TABLET [AUROBINDO PHARMA LIMITED]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFOSINOPRIL SODIUM TABLET [AUROBINDO PHARMA LIMITED]5
CROSPOVIDONEINACTIVE INGREDIENT68401960MKFOSINOPRIL SODIUM TABLET [AUROBINDO PHARMA LIMITED]5
POVIDONE K30INACTIVE INGREDIENTU725QWY32XFOSINOPRIL SODIUM TABLET [AUROBINDO PHARMA LIMITED]5
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIFOSINOPRIL SODIUM TABLET [AUROBINDO PHARMA LIMITED]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-472FOSINOPRIL SODIUM TABLET [AUROBINDO PHARMA LIMITED]8Current NDC, Legacy NDC, 3 package rows20240518_aee04f17-8ee9-42f5-861f-b6ba17220ca4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857169fosinopril sodium 10 MG Oral TabletPSNaee04f17-8ee9-42f5-861f-b6ba17220ca48
857183fosinopril sodium 20 MG Oral TabletPSNaee04f17-8ee9-42f5-861f-b6ba17220ca48
857187fosinopril sodium 40 MG Oral TabletPSNaee04f17-8ee9-42f5-861f-b6ba17220ca48
857169fosinopril sodium 10 MG Oral TabletSCDaee04f17-8ee9-42f5-861f-b6ba17220ca48
857183fosinopril sodium 20 MG Oral TabletSCDaee04f17-8ee9-42f5-861f-b6ba17220ca48
857187fosinopril sodium 40 MG Oral TabletSCDaee04f17-8ee9-42f5-861f-b6ba17220ca48
857169FNP Sodium 10 MG Oral TabletSYaee04f17-8ee9-42f5-861f-b6ba17220ca48
857183FNP Sodium 20 MG Oral TabletSYaee04f17-8ee9-42f5-861f-b6ba17220ca48
857187FNP Sodium 40 MG Oral TabletSYaee04f17-8ee9-42f5-861f-b6ba17220ca48

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-472-306586204723030 TABLET in 1 BOTTLE (65862-472-30) 30 tablet2011-03-300000-00-00NoNoCurrent
65862-472-39658620472393000 TABLET in 1 BAG (65862-472-39)3000 tablet30-MAR-11Current
65862-472-906586204729090 TABLET in 1 BOTTLE (65862-472-90) 90 tablet2011-03-300000-00-00NoNoCurrent
65862-472-99658620472991000 TABLET in 1 BOTTLE (65862-472-99) 1000 tablet2011-03-300000-00-00NoNoCurrent