FDA.reportPublic FDA data

Ferrlecit

Product NDC
0024-2794
11-digit product format
000242794
Labeler code
0024
Product ID
0024-2794_df1cd4cc-f035-435c-a17e-381071f0d9e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sodium ferric gluconate complex
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
sanofi-aventis U.S. LLC
Application
NDA020955
Marketing category
NDA
Marketing start
2014-07-07
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
Ferrlecit
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, 261123

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
0024-2794-01Ferrlecit5 mL in 1 VIAL, SINGLE-USEINJECTION512
0024-2794-10Ferrlecit10 in 1 CARTONINJECTION1012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0024-2794-01ML - Milliliter0024-27946d53665e-0f6d-4aa2-a835-94aa8d6e859b12021-05-05
0024-2794-10ML - Milliliter0024-2794c71cb8ff-efef-4f1c-a0e0-44fe41825bd012014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
sodium ferric gluconate complexACTIVE INGREDIENTCC9149U2QXFERRLECIT (SODIUM FERRIC GLUCONATE COMPLEX) INJECTION [SANOFI-AVENTIS U.S. LLC]1
ferric cationACTIVE MOIETY91O4LML611FERRLECIT (SODIUM FERRIC GLUCONATE COMPLEX) INJECTION [SANOFI-AVENTIS U.S. LLC]1
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHFERRLECIT (SODIUM FERRIC GLUCONATE COMPLEX) INJECTION [SANOFI-AVENTIS U.S. LLC]1
sucroseINACTIVE INGREDIENTC151H8M554FERRLECIT (SODIUM FERRIC GLUCONATE COMPLEX) INJECTION [SANOFI-AVENTIS U.S. LLC]1
waterINACTIVE INGREDIENT059QF0KO0RFERRLECIT (SODIUM FERRIC GLUCONATE COMPLEX) INJECTION [SANOFI-AVENTIS U.S. LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0024-2794FERRLECIT (SODIUM FERRIC GLUCONATE COMPLEX) INJECTION [SANOFI-AVENTIS U.S. LLC]10Current NDC, Legacy NDC, 2 package rows20220330_b25b34ab-9cf1-4a2b-bdf2-5eaf66625999.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
261123Ferrlecit (iron) 62.5 MG in 5 mL InjectionPSNb25b34ab-9cf1-4a2b-bdf2-5eaf6662599912
242761sodium ferric gluconate complex (as iron) 62.5 MG in 5 mL InjectionPSNb25b34ab-9cf1-4a2b-bdf2-5eaf6662599912
2611235 ML sodium ferric gluconate complex 12.5 MG/ML Injection [Ferrlecit]SBDb25b34ab-9cf1-4a2b-bdf2-5eaf6662599912
2427615 ML sodium ferric gluconate complex 12.5 MG/ML InjectionSCDb25b34ab-9cf1-4a2b-bdf2-5eaf6662599912
2611235 ML Ferrlecit 12.5 MG/ML InjectionSYb25b34ab-9cf1-4a2b-bdf2-5eaf6662599912
261123Ferrlecit (as elemental iron) 62.5 MG per 5 ML InjectionSYb25b34ab-9cf1-4a2b-bdf2-5eaf6662599912
242761sodium ferric gluconate complex (as elemental iron) 62.5 MG per 5 ML InjectionSYb25b34ab-9cf1-4a2b-bdf2-5eaf6662599912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0024-2794-01000242794015 mL in 1 VIAL, SINGLE-USE5 mlHistorical
0024-2794-100002427941010 VIAL, SINGLE-USE in 1 CARTON (0024-2794-10) / 5 mL in 1 VIAL, SINGLE-USE (0024-2794-01) 2014-07-070000-00-00NoNoCurrent