FDA.reportPublic FDA data

Iron Sucrose

Product NDC
67457-638
11-digit product format
674570638
Labeler code
67457
Product ID
67457-638_3f109bdb-a412-43b2-84c7-9dad05e85a71
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Iron Sucrose
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
ANDA212559
Marketing category
ANDA
Marketing start
2025-08-11
Substance
IRON SUCROSE
Active strength
100 mg/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 SUCROSE100 mg/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
67457-638-00Iron Sucrose5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION51
67457-638-00Iron Sucrose1 in 1 CARTONINJECTION, SOLUTION11
67457-638-10Iron Sucrose10 in 1 CARTONINJECTION, SOLUTION101
67457-638-10Iron Sucrose5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION51
67457-638-25Iron Sucrose25 in 1 CARTONINJECTION, SOLUTION251
67457-638-25Iron Sucrose5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-638-00ML - Milliliter67457-638197d9bb3-e290-4b8e-822c-439b9acb3c0512025-09-12
67457-638-10ML - Milliliter67457-6387efc2514-bac3-4899-8d95-b4b35731bf0512025-09-12
67457-638-25ML - Milliliter67457-638ed4ccb2f-9114-492a-82b1-272a2afa6a9512025-09-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1741267iron (as iron sucrose) 100 MG in 5 ML InjectionPSN3f109bdb-a412-43b2-84c7-9dad05e85a711
1741261iron (as iron sucrose) 200 MG in 10 ML InjectionPSN3f109bdb-a412-43b2-84c7-9dad05e85a711
1741270iron (as iron sucrose) 50 MG in 2.5 mL InjectionPSN3f109bdb-a412-43b2-84c7-9dad05e85a711
174126110 ML iron sucrose 20 MG/ML InjectionSCD3f109bdb-a412-43b2-84c7-9dad05e85a711
17412702.5 ML iron sucrose 20 MG/ML InjectionSCD3f109bdb-a412-43b2-84c7-9dad05e85a711
17412675 ML iron sucrose 20 MG/ML InjectionSCD3f109bdb-a412-43b2-84c7-9dad05e85a711
1741267ferric oxide, saccharated 100 MG per 5 ML InjectionSY3f109bdb-a412-43b2-84c7-9dad05e85a711
1741261ferric oxide, saccharated 200 MG per 10 ML InjectionSY3f109bdb-a412-43b2-84c7-9dad05e85a711
1741270ferric oxide, saccharated 50 MG per 2.5 ML InjectionSY3f109bdb-a412-43b2-84c7-9dad05e85a711
1741267iron (as iron sucrose) 100 MG per 5 ML InjectionSY3f109bdb-a412-43b2-84c7-9dad05e85a711
1741261iron (as iron sucrose) 200 MG per 10 ML InjectionSY3f109bdb-a412-43b2-84c7-9dad05e85a711
1741270iron (as iron sucrose) 50 MG per 2.5 ML InjectionSY3f109bdb-a412-43b2-84c7-9dad05e85a711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67457-638-00674570638005 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
67457-638-106745706381010 VIAL, SINGLE-DOSE in 1 CARTON (67457-638-10) / 5 mL in 1 VIAL, SINGLE-DOSE2025-08-11NoNoHistorical
67457-638-256745706382525 VIAL, SINGLE-DOSE in 1 CARTON (67457-638-25) / 5 mL in 1 VIAL, SINGLE-DOSE2025-08-11NoNoHistorical