FDA.reportPublic FDA data

Ferrlecit

Product NDC
0024-2792
11-digit product format
000242792
Labeler code
0024
Product ID
0024-2792_2552acd1-62ae-49aa-9f88-e3baba1db724
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
2011-03-01
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
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
0024-2792-01Ferrlecit5 mL in 1 VIAL, SINGLE-USEINJECTION516
0024-2792-10Ferrlecit10 in 1 CARTONINJECTION1016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0024-2792-01ML - Milliliter0024-279205fcf687-5eca-4797-951f-aeb29221c28812021-05-05
0024-2792-10ML - Milliliter0024-2792c46f7eef-9494-48f7-b9f6-f60b84acfbc112012-07-24

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]3
ferric cationACTIVE MOIETY91O4LML611FERRLECIT (SODIUM FERRIC GLUCONATE COMPLEX) INJECTION [SANOFI-AVENTIS U.S. LLC]3
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHFERRLECIT (SODIUM FERRIC GLUCONATE COMPLEX) INJECTION [SANOFI-AVENTIS U.S. LLC]3
sucroseINACTIVE INGREDIENTC151H8M554FERRLECIT (SODIUM FERRIC GLUCONATE COMPLEX) INJECTION [SANOFI-AVENTIS U.S. LLC]3
waterINACTIVE INGREDIENT059QF0KO0RFERRLECIT (SODIUM FERRIC GLUCONATE COMPLEX) INJECTION [SANOFI-AVENTIS U.S. LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0024-2792FERRLECIT (SODIUM FERRIC GLUCONATE COMPLEX) INJECTION [SANOFI-AVENTIS U.S. LLC]15Current NDC, Legacy NDC, 2 package rows20250525_1fe028ff-42ac-4329-b1a5-a9dadfcb79f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
261123Ferrlecit (iron) 62.5 MG in 5 mL InjectionPSN1fe028ff-42ac-4329-b1a5-a9dadfcb79f616
242761sodium ferric gluconate complex (as iron) 62.5 MG in 5 mL InjectionPSN1fe028ff-42ac-4329-b1a5-a9dadfcb79f616
2611235 ML sodium ferric gluconate complex 12.5 MG/ML Injection [Ferrlecit]SBD1fe028ff-42ac-4329-b1a5-a9dadfcb79f616
2427615 ML sodium ferric gluconate complex 12.5 MG/ML InjectionSCD1fe028ff-42ac-4329-b1a5-a9dadfcb79f616
2611235 ML Ferrlecit 12.5 MG/ML InjectionSY1fe028ff-42ac-4329-b1a5-a9dadfcb79f616
261123Ferrlecit (as elemental iron) 62.5 MG per 5 ML InjectionSY1fe028ff-42ac-4329-b1a5-a9dadfcb79f616
242761sodium ferric gluconate complex (as elemental iron) 62.5 MG per 5 ML InjectionSY1fe028ff-42ac-4329-b1a5-a9dadfcb79f616

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0024-2792-01000242792015 mL in 1 VIAL, SINGLE-USE5 mlHistorical
0024-2792-100002427921010 VIAL, SINGLE-USE in 1 CARTON (0024-2792-10) / 5 mL in 1 VIAL, SINGLE-USE (0024-2792-01) 2011-03-010000-00-00NoNoCurrent