FDA.reportPublic FDA data

Sodium Ferric Gluconate Complex in Sucrose

Product NDC
0143-9298
11-digit product format
001439298
Labeler code
0143
Product ID
0143-9298_4272216c-1e53-4180-a731-0592e772666f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Ferric Gluconate Complex in Sucrose
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA078215
Marketing category
ANDA
Marketing start
2011-03-31
Substance
SODIUM FERRIC GLUCONATE COMPLEX
Active strength
12.5 mg/mL
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
Sodium Ferric Gluconate Complex in Sucrose
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FERRIC GLUCONATE COMPLEX12.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCC9149U2QX
Rxcui242761

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
ef06c001-572c-d95e-42f6-ee83da75673aProduct name120140508
fd21f957-6863-d07b-5a35-250186878716Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9298-01Sodium Ferric Gluconate Complex in Sucrose5 mL in 1 VIAL, SINGLE-DOSEINJECTION55
0143-9298-10Sodium Ferric Gluconate Complex in Sucrose10 in 1 CARTONINJECTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9298-01ML - Milliliter0143-9298a5376a93-9178-4b2c-a4b0-4269ce8254d912018-03-08
0143-9298-10ML - Milliliter0143-92985bbd4413-8e38-450b-9ec5-26cdd708d47012018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9298SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION [HIKMA PHARMACEUTICALS USA INC.]5Current NDC, Legacy NDC, 2 package rows20230609_36377351-d208-4363-8826-0acfea3f0cc1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242761sodium ferric gluconate complex (as iron) 62.5 MG in 5 mL InjectionPSN36377351-d208-4363-8826-0acfea3f0cc15
2427615 ML sodium ferric gluconate complex 12.5 MG/ML InjectionSCD36377351-d208-4363-8826-0acfea3f0cc15
242761sodium ferric gluconate complex (as elemental iron) 62.5 MG per 5 ML InjectionSY36377351-d208-4363-8826-0acfea3f0cc15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9298-01001439298015 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
0143-9298-100014392981010 VIAL, SINGLE-DOSE in 1 CARTON (0143-9298-10) / 5 mL in 1 VIAL, SINGLE-DOSE (0143-9298-01) 2011-03-310000-00-00NoNoCurrent