Sodium Ferric Gluconate Complex in Sucrose

Product NDC
0143-9570
11-digit product format
001439570
Labeler code
0143
Product ID
0143-9570_7a57fb1e-f803-4f81-a643-6fc18d8371ff
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
0143-9570-01Sodium Ferric Gluconate Complex in Sucrose5 mL in 1 VIALINJECTION57
0143-9570-10Sodium Ferric Gluconate Complex in Sucrose10 in 1 CARTONINJECTION107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9570-01ML - Milliliter0143-95701c933de3-c245-4437-b3bd-54c7ac4a410512015-05-05
0143-9570-10ML - Milliliter0143-9570a14744b3-74db-459e-b191-bdf39741c24c12015-05-05

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9570SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION [HIKMA PHARMACEUTICALS USA INC.]7Current NDC, Legacy NDC, 2 package rows20250323_218d1b8d-b24f-4f77-b588-97c7dd1c2eec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242761sodium ferric gluconate complex (as iron) 62.5 MG in 5 mL InjectionPSN218d1b8d-b24f-4f77-b588-97c7dd1c2eec7
2427615 ML sodium ferric gluconate complex 12.5 MG/ML InjectionSCD218d1b8d-b24f-4f77-b588-97c7dd1c2eec7
242761sodium ferric gluconate complex (as elemental iron) 62.5 MG per 5 ML InjectionSY218d1b8d-b24f-4f77-b588-97c7dd1c2eec7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9570-01001439570015 mL in 1 VIAL5 mlHistorical
0143-9570-100014395701010 VIAL in 1 CARTON (0143-9570-10) / 5 mL in 1 VIAL (0143-9570-01) 10 vial2011-03-310000-00-00NoNoCurrent