FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
Iron Sucrose
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IRON SUCROSE50 mg/2.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFZ7NYF5N8L
Rxcui1741261, 1741267, 1741270

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
04cdd491-d111-4bc2-9549-75c575e1bd4bProduct name120200714
8390fb8b-6c75-416c-a9a1-70e8ed493b73Product name120200611
96a528e9-23e2-495f-81b9-ae87df2f7552Product name120191120
3df56c93-5837-4523-aac2-4b1ec48b9676Product name220160719
a883b7cc-d320-41d7-92ae-c873457ae641Product name120151116
bb23e78e-9e64-4037-a1c1-0e1d8762700eProduct name120150325
ef06c001-572c-d95e-42f6-ee83da75673aProduct name120140508
fd21f957-6863-d07b-5a35-250186878716Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-3485-56Iron Sucrose2.5 mL in 1 VIAL, SINGLE-DOSEINJECTION2.51
0781-3485-95Iron Sucrose10 in 1 CARTONINJECTION101
0781-3485-96Iron Sucrose2.5 mL in 1 VIAL, SINGLE-DOSEINJECTION2.51
0781-3485-96Iron Sucrose25 in 1 CARTONINJECTION251

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3485-56ML - Milliliter0781-3485b64e9832-4f81-441c-8e5b-f22ff799c29b12025-10-14
0781-3485-95ML - Milliliter0781-3485a35aefd7-35f2-40f6-832e-875b78551f0c12025-10-14
0781-3485-96ML - Milliliter0781-3485506f0db8-22af-4521-adfa-bde91d7c592b12025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1741267iron (as iron sucrose) 100 MG in 5 ML InjectionPSN78c04f10-0489-4e45-8cb5-28a6789d11491
1741261iron (as iron sucrose) 200 MG in 10 ML InjectionPSN78c04f10-0489-4e45-8cb5-28a6789d11491
1741270iron (as iron sucrose) 50 MG in 2.5 mL InjectionPSN78c04f10-0489-4e45-8cb5-28a6789d11491
174126110 ML iron sucrose 20 MG/ML InjectionSCD78c04f10-0489-4e45-8cb5-28a6789d11491
17412702.5 ML iron sucrose 20 MG/ML InjectionSCD78c04f10-0489-4e45-8cb5-28a6789d11491
17412675 ML iron sucrose 20 MG/ML InjectionSCD78c04f10-0489-4e45-8cb5-28a6789d11491
1741267ferric oxide, saccharated 100 MG per 5 ML InjectionSY78c04f10-0489-4e45-8cb5-28a6789d11491
1741261ferric oxide, saccharated 200 MG per 10 ML InjectionSY78c04f10-0489-4e45-8cb5-28a6789d11491
1741270ferric oxide, saccharated 50 MG per 2.5 ML InjectionSY78c04f10-0489-4e45-8cb5-28a6789d11491
1741267iron (as iron sucrose) 100 MG per 5 ML InjectionSY78c04f10-0489-4e45-8cb5-28a6789d11491
1741261iron (as iron sucrose) 200 MG per 10 ML InjectionSY78c04f10-0489-4e45-8cb5-28a6789d11491
1741270iron (as iron sucrose) 50 MG per 2.5 ML InjectionSY78c04f10-0489-4e45-8cb5-28a6789d11491

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0781-3485-56007813485562.5 mL in 1 VIAL, SINGLE-DOSE2.5 mlHistorical
0781-3485-950078134859510 VIAL, SINGLE-DOSE in 1 CARTON (0781-3485-95) / 2.5 mL in 1 VIAL, SINGLE-DOSE (0781-3485-56) 2025-09-22NoNoCurrent
0781-3485-960078134859625 VIAL, SINGLE-DOSE in 1 CARTON (0781-3485-96) / 2.5 mL in 1 VIAL, SINGLE-DOSE2025-09-22NoNoCurrent