Iron Sucrose

Product NDC
0781-3485
11-digit product format
007813485
Labeler code
0781
Product ID
0781-3485_78c04f10-0489-4e45-8cb5-28a6789d1149
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Iron Sucrose
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Sandoz Inc
Application
ANDA212340
Marketing category
ANDA
Marketing start
2025-09-22
Substance
IRON SUCROSE
Active strength
50 mg/2.5mL
Pharmacologic classes
Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
FZ7NYF5N8LIRON SUCROSE8047-67-4IRON SUCROSE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0781-3485-950078134859510 VIAL, SINGLE-DOSE in 1 CARTON (0781-3485-95) / 2.5 mL in 1 VIAL, SINGLE-DOSE (0781-3485-56) 2025-09-22NoNoHistorical
0781-3485-960078134859625 VIAL, SINGLE-DOSE in 1 CARTON (0781-3485-96) / 2.5 mL in 1 VIAL, SINGLE-DOSE2025-09-22NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Iron SucroseSandoz Inc2025-06-30HUMAN PRESCRIPTION DRUG LABEL1