FDA.reportPublic FDA data

Ferumoxytol

Product NDC
0781-3154
11-digit product format
007813154
Labeler code
0781
Product ID
0781-3154_7374e3ff-0761-45f0-bb76-bf1b74a20480
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ferumoxytol
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Sandoz Inc
Application
ANDA206604
Marketing category
ANDA
Marketing start
2021-07-15
Substance
FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE
Active strength
510 mg/17mL
Pharmacologic classes
Iron [CS], Parenteral Iron Replacement [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ferumoxytol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE510 mg/17mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCLH5FT6412
Rxcui860605

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
910c1bd7-67d1-44c7-ad4f-9445f827edccProduct name120230808

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0781-3154-012023-08-02C16284748780-10191ceaa-63f1-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use FERUMOXYTOL INJECTION safely and effectively. See full prescribing information for FERUMOXYTOL INJECTION. FERUMOXYTOL injection, for intravenous use Initial U.S. Approval: 2009
0781-3154-952023-08-02C16284748780-10191ceaa-63f1-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use FERUMOXYTOL INJECTION safely and effectively. See full prescribing information for FERUMOXYTOL INJECTION. FERUMOXYTOL injection, for intravenous use Initial U.S. Approval: 2009
0781-3154-012023-07-28C16284748780-10191ceaa-63f1-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use FERUMOXYTOL INJECTION safely and effectively. See full prescribing information for FERUMOXYTOL INJECTION. FERUMOXYTOL injection, for intravenous use Initial U.S. Approval: 2009
0781-3154-952023-07-28C16284748780-10191ceaa-63f1-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use FERUMOXYTOL INJECTION safely and effectively. See full prescribing information for FERUMOXYTOL INJECTION. FERUMOXYTOL injection, for intravenous use Initial U.S. Approval: 2009

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-3154-01Ferumoxytol1 in 1 CARTONINJECTION16
0781-3154-01Ferumoxytol17 mL in 1 VIAL, SINGLE-DOSEINJECTION176
0781-3154-95Ferumoxytol10 in 1 CARTONINJECTION106
0781-3154-95Ferumoxytol17 mL in 1 VIAL, SINGLE-DOSEINJECTION176

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3154-01ML - Milliliter0781-3154519a55f6-ffd6-44e2-a582-fef667997ae112021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-3154FERUMOXYTOL INJECTION [SANDOZ INC]5Current NDC, Legacy NDC, 4 package rows20230803_cf94c7fc-13a0-4ac9-bb85-9c38aa704d35.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860605iron (as ferumoxytol) 510 MG in 17 ML InjectionPSNcf94c7fc-13a0-4ac9-bb85-9c38aa704d356
86060517 ML ferumoxytol 30 MG/ML InjectionSCDcf94c7fc-13a0-4ac9-bb85-9c38aa704d356
860605iron (as ferumoxytol) 510 MG per 17 ML InjectionSYcf94c7fc-13a0-4ac9-bb85-9c38aa704d356

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-3154-01007813154011 VIAL, SINGLE-DOSE in 1 CARTON (0781-3154-01) / 17 mL in 1 VIAL, SINGLE-DOSE2021-07-150000-00-00NoNoCurrent
0781-3154-950078131549510 VIAL, SINGLE-DOSE in 1 CARTON (0781-3154-95) / 17 mL in 1 VIAL, SINGLE-DOSE2021-07-150000-00-00NoNoCurrent