FDA.reportPublic FDA data

Fosinopril sodium

Product NDC
43547-386
11-digit product format
435470386
Labeler code
43547
Product ID
43547-386_e39b61db-42b8-4ddf-89d1-549c08d49e71
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fosinopirl sodium
Dosage form
TABLET
Route
ORAL
Labeler
Solco Healthcare LLC
Application
ANDA205670
Marketing category
ANDA
Marketing start
2017-10-01
Substance
FOSINOPRIL SODIUM
Active strength
10 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 SODIUM10 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
43547-386-09Fosinopril sodium90 in 1 BOTTLETABLET903
43547-386-11Fosinopril sodium1000 in 1 BOTTLETABLET10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-386-09EA - Each43547-386c70b4399-70d5-41d6-a8fd-f90b8ff31b1f12017-11-06
43547-386-11EA - Each43547-386001814b9-a51a-4930-b6fa-f5c851fd08cf12017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-386FOSINOPRIL SODIUM (FOSINOPIRL SODIUM) TABLET FOSINOPRIL SODIUM TABLET [SOLCO HEALTHCARE LLC]2Current NDC, Legacy NDC, 2 package rows20200120_0a66f606-5e6f-473d-8a1e-9ef316adb2e2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857169fosinopril sodium 10 MG Oral TabletPSN3d521d4d-29f8-40d7-971b-0efb68dfbff27
857169fosinopril sodium 10 MG Oral TabletSCD3d521d4d-29f8-40d7-971b-0efb68dfbff27
857169FNP Sodium 10 MG Oral TabletSY3d521d4d-29f8-40d7-971b-0efb68dfbff27
857169fosinopril sodium 10 MG Oral TabletPSN0a66f606-5e6f-473d-8a1e-9ef316adb2e23
857169fosinopril sodium 10 MG Oral TabletPSN9ff203c2-b29b-4cdb-9bd3-2eac190dae5c3
857183fosinopril sodium 20 MG Oral TabletPSN0a66f606-5e6f-473d-8a1e-9ef316adb2e23
857187fosinopril sodium 40 MG Oral TabletPSN0a66f606-5e6f-473d-8a1e-9ef316adb2e23
857169fosinopril sodium 10 MG Oral TabletSCD0a66f606-5e6f-473d-8a1e-9ef316adb2e23
857169fosinopril sodium 10 MG Oral TabletSCD9ff203c2-b29b-4cdb-9bd3-2eac190dae5c3
857183fosinopril sodium 20 MG Oral TabletSCD0a66f606-5e6f-473d-8a1e-9ef316adb2e23
857187fosinopril sodium 40 MG Oral TabletSCD0a66f606-5e6f-473d-8a1e-9ef316adb2e23
857169FNP Sodium 10 MG Oral TabletSY0a66f606-5e6f-473d-8a1e-9ef316adb2e23
857169FNP Sodium 10 MG Oral TabletSY9ff203c2-b29b-4cdb-9bd3-2eac190dae5c3
857183FNP Sodium 20 MG Oral TabletSY0a66f606-5e6f-473d-8a1e-9ef316adb2e23
857187FNP Sodium 40 MG Oral TabletSY0a66f606-5e6f-473d-8a1e-9ef316adb2e23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43547-386-094354703860990 TABLET in 1 BOTTLE (43547-386-09) 90 tablet2017-10-010000-00-00NoNoCurrent
43547-386-11435470386111000 TABLET in 1 BOTTLE (43547-386-11) 1000 tablet2017-10-010000-00-00NoNoCurrent