FDA.reportPublic FDA data

Fosinopril Sodium

Product NDC
69097-858
11-digit product format
690970858
Labeler code
69097
Product ID
69097-858_6d672087-9b6a-4afe-8c3e-0616943a82cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fosinopril
Dosage form
TABLET
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA077222
Marketing category
ANDA
Marketing start
2016-06-16
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69097-858-05Fosinopril Sodium90 in 1 BOTTLETABLET906
69097-858-15Fosinopril Sodium1000 in 1 BOTTLETABLET10006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-858-05EA - Each69097-858cf4cf3d6-f454-4ab4-8b8f-4442ec8dbe6912016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-858FOSINOPRIL SODIUM (FOSINOPRIL) TABLET [CIPLA USA INC.]6Current NDC, Legacy NDC, 2 package rows20230121_736fe52f-69fb-48b2-b1c5-f06531878538.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857169fosinopril sodium 10 MG Oral TabletPSN880e5bf4-ced8-4765-a5c2-2361fd06ed9c19
857187fosinopril sodium 40 MG Oral TabletPSN880e5bf4-ced8-4765-a5c2-2361fd06ed9c19
857169fosinopril sodium 10 MG Oral TabletSCD880e5bf4-ced8-4765-a5c2-2361fd06ed9c19
857187fosinopril sodium 40 MG Oral TabletSCD880e5bf4-ced8-4765-a5c2-2361fd06ed9c19
857169FNP Sodium 10 MG Oral TabletSY880e5bf4-ced8-4765-a5c2-2361fd06ed9c19
857187FNP Sodium 40 MG Oral TabletSY880e5bf4-ced8-4765-a5c2-2361fd06ed9c19
857169fosinopril sodium 10 MG Oral TabletPSN736fe52f-69fb-48b2-b1c5-f065318785386
857183fosinopril sodium 20 MG Oral TabletPSN736fe52f-69fb-48b2-b1c5-f065318785386
857187fosinopril sodium 40 MG Oral TabletPSN736fe52f-69fb-48b2-b1c5-f065318785386
857169fosinopril sodium 10 MG Oral TabletSCD736fe52f-69fb-48b2-b1c5-f065318785386
857183fosinopril sodium 20 MG Oral TabletSCD736fe52f-69fb-48b2-b1c5-f065318785386
857187fosinopril sodium 40 MG Oral TabletSCD736fe52f-69fb-48b2-b1c5-f065318785386
857169FNP Sodium 10 MG Oral TabletSY736fe52f-69fb-48b2-b1c5-f065318785386
857183FNP Sodium 20 MG Oral TabletSY736fe52f-69fb-48b2-b1c5-f065318785386
857187FNP Sodium 40 MG Oral TabletSY736fe52f-69fb-48b2-b1c5-f065318785386

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-858-056909708580590 TABLET in 1 BOTTLE (69097-858-05) 90 tablet2016-06-160000-00-00NoNoCurrent
69097-858-15690970858151000 TABLET in 1 BOTTLE (69097-858-15) 1000 tablet2016-06-160000-00-00NoNoCurrent