FDA.reportPublic FDA data

Injectafer

Product NDC
0517-0620
11-digit product format
005170620
Labeler code
0517
Product ID
0517-0620_a092ebb6-505b-464f-9669-194a913ff8e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ferric Carboxymaltose
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
American Regent, Inc.
Application
NDA203565
Marketing category
NDA
Marketing start
2021-06-01
Substance
FERRIC CARBOXYMALTOSE
Active strength
50 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
Injectafer
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FERRIC CARBOXYMALTOSE50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6897GXD6OE
Rxcui1435169, 1435174, 2552400, 2552401, 2602296, 2602297

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
0517-0620-01Injectafer20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION2029
0517-0620-01Injectafer1 in 1 BOXINJECTION, SOLUTION129

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0517-0620-01ML - Milliliter0517-06206566f37f-c51e-4e44-936b-7d137418a27412025-10-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FERRIC CARBOXYMALTOSEACTIVE INGREDIENT6897GXD6OEINJECTAFER (FERRIC CARBOXYMALTOSE INJECTION) INJECTION, SOLUTION [AMERICAN REGENT, INC.]3
FERRIC CATIONACTIVE MOIETY91O4LML611INJECTAFER (FERRIC CARBOXYMALTOSE INJECTION) INJECTION, SOLUTION [AMERICAN REGENT, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RINJECTAFER (FERRIC CARBOXYMALTOSE INJECTION) INJECTION, SOLUTION [AMERICAN REGENT, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0517-0620INJECTAFER (FERRIC CARBOXYMALTOSE INJECTION) INJECTION, SOLUTION INJECTAFER (FERRIC CARBOXYMALTOSE) INJECTION, SOLUTION [AMERICAN REGENT, INC.]29Current NDC, Legacy NDC, 2 package rows20250108_517b4a19-45b3-4286-9f6a-ced4e10447de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1435169ferric carboxymaltose (as iron) 750 MG in 15 mL InjectionPSN517b4a19-45b3-4286-9f6a-ced4e10447de29
2552400ferric carboxymaltose (iron) 1000 MG in 20 mL InjectionPSN517b4a19-45b3-4286-9f6a-ced4e10447de29
2602296ferric carboxymaltose 100 MG in 2 ML InjectionPSN517b4a19-45b3-4286-9f6a-ced4e10447de29
2602297Injectafer (iron) 100 MG in 2 mL InjectionPSN517b4a19-45b3-4286-9f6a-ced4e10447de29
2552401Injectafer (iron) 1000 MG in 20 ML InjectionPSN517b4a19-45b3-4286-9f6a-ced4e10447de29
1435174Injectafer (iron) 750 MG in 15 mL InjectionPSN517b4a19-45b3-4286-9f6a-ced4e10447de29
143517415 ML ferric carboxymaltose 50 MG/ML Injection [Injectafer]SBD517b4a19-45b3-4286-9f6a-ced4e10447de29
26022972 ML ferric carboxymaltose 50 MG/ML Injection [Injectafer]SBD517b4a19-45b3-4286-9f6a-ced4e10447de29
255240120 ML ferric carboxymaltose 50 MG/ML Injection [Injectafer]SBD517b4a19-45b3-4286-9f6a-ced4e10447de29
143516915 ML ferric carboxymaltose 50 MG/ML InjectionSCD517b4a19-45b3-4286-9f6a-ced4e10447de29
26022962 ML ferric carboxymaltose 50 MG/ML InjectionSCD517b4a19-45b3-4286-9f6a-ced4e10447de29
255240020 ML ferric carboxymaltose 50 MG/ML InjectionSCD517b4a19-45b3-4286-9f6a-ced4e10447de29
143517415 ML Injectafer 50 MG/ML InjectionSY517b4a19-45b3-4286-9f6a-ced4e10447de29
26022972 ML Injectafer 50 MG/ML InjectionSY517b4a19-45b3-4286-9f6a-ced4e10447de29
255240120 ML Injectafer 50 MG/ML InjectionSY517b4a19-45b3-4286-9f6a-ced4e10447de29
2552400ferric carboxymaltose (as elemental iron) 1000 MG per 20 ML InjectionSY517b4a19-45b3-4286-9f6a-ced4e10447de29
1435169ferric carboxymaltose (as elemental iron) 750 MG per 15 ML InjectionSY517b4a19-45b3-4286-9f6a-ced4e10447de29
2602296ferric carboxymaltose 100 MG per 2 ML InjectionSY517b4a19-45b3-4286-9f6a-ced4e10447de29
2552401Injectafer (as elemental iron) 1000 MG per 20 ML InjectionSY517b4a19-45b3-4286-9f6a-ced4e10447de29
1435174Injectafer (as elemental iron) 750 MG per 15 ML InjectionSY517b4a19-45b3-4286-9f6a-ced4e10447de29

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0517-0620-01005170620011 VIAL, SINGLE-DOSE in 1 BOX (0517-0620-01) / 20 mL in 1 VIAL, SINGLE-DOSE2021-06-010000-00-00NoNoCurrent