FDA.reportPublic FDA data

Triferic

Product NDC
57278-315
11-digit product format
572780315
Labeler code
57278
Product ID
57278-315_af5e96dc-661a-5180-e053-2a95a90a6edc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FERRIC PYROPHOSPHATE CITRATE
Dosage form
POWDER
Route
INTRAVENOUS
Labeler
Rockwell Medical, Inc
Application
NDA208551
Marketing category
NDA
Marketing start
2016-04-25
Marketing end
0000-00-00
Substance
FERRIC PYROPHOSPHATE CITRATE
Active strength
272 mg/1
Pharmacologic classes
Iron [CS],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct57278-315IInactivated by FDA2026-07-31
excluded packagepackage57278-31557278-315-02IInactivated by FDA2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N208551-001TRIFERICFERRIC PYROPHOSPHATE CITRATE272MG IRON/PACKETPOWDER / INTRAVENOUSRLD2016-04-25

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N208551-00178579772027-09-08U-16562017-03-27
N208551-00178164042029-04-17U-16562017-03-27

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N208551-001TRIFERIC272MG IRON/PACKETPOWDER / INTRAVENOUSRLD2016-04-25a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N208551-00178579772027-09-08U-16562017-03-27a50c72e98297…
2026-08-01 22:54:322026-06N208551-00178164042029-04-17U-16562017-03-27a50c72e98297…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57278-315-022023-01-30C16284748780-1f386c649-ea67-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TRIFERIC safely and effectively. See full prescribing information for TRIFERIC. TRIFERIC ® (ferric pyrophosphate citrate) solution, for hemodialysis use TRIFERIC ® (ferric pyrophosphate citrate) for solution, for hemodialysis use Initial U.S. Approval: 2015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57278-315-02Triferic100 in 1 CARTONPOWDER10014
57278-315-02Triferic1 in 1 PACKETPOWDER114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57278-315-02EA - Each57278-315ef2e4c19-3e22-4c09-a4e0-21d03a3ac59e12017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FERRIC PYROPHOSPHATE CITRATEACTIVE INGREDIENTUBY79OCO9GTRIFERIC (FERRIC PYROPHOSPHATE) SOLUTION [ROCKWELL MEDICAL, INC]2
FERRIC CATIONACTIVE MOIETY91O4LML611TRIFERIC (FERRIC PYROPHOSPHATE) SOLUTION [ROCKWELL MEDICAL, INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57278-315TRIFERIC (FERRIC PYROPHOSPHATE) SOLUTION TRIFERIC (FERRIC PYROPHOSPHATE CITRATE) POWDER [ROCKWELL MEDICAL, INC]14Legacy NDC, 2 package rows20200916_46ec9233-4063-4c48-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1790866ferric pyrophosphate (as iron) 272 MG hemodialysis InjectionPSN46ec9233-4063-4c48-e054-00144ff8d46c14
1855508ferric pyrophosphate citrate (as iron) 27.2 MG in 5 mL hemodialysis InjectionPSN46ec9233-4063-4c48-e054-00144ff8d46c14
1855509Triferic (iron) 27.2 MG in 5 mL hemodialysis InjectionPSN46ec9233-4063-4c48-e054-00144ff8d46c14
1790869Triferic (iron) 272 MG hemodialysis InjectionPSN46ec9233-4063-4c48-e054-00144ff8d46c14
18555095 ML ferric pyrophosphate citrate 5.44 MG/ML Injection [Triferic]SBD46ec9233-4063-4c48-e054-00144ff8d46c14
1790869ferric pyrophosphate citrate 272 MG Injection [Triferic]SBD46ec9233-4063-4c48-e054-00144ff8d46c14
18555085 ML ferric pyrophosphate citrate 5.44 MG/ML InjectionSCD46ec9233-4063-4c48-e054-00144ff8d46c14
1790866ferric pyrophosphate citrate 272 MG InjectionSCD46ec9233-4063-4c48-e054-00144ff8d46c14
1790866ferric pyrophosphate (as elemental iron) 272 MG hemodialysis InjectionSY46ec9233-4063-4c48-e054-00144ff8d46c14
1855508ferric pyrophosphate citrate (as iron) 27.2 MG per 5 ML hemodialysis InjectionSY46ec9233-4063-4c48-e054-00144ff8d46c14
1855509Triferic (as elemental iron) 27.2 MG per 5 ML hemodialysis InjectionSY46ec9233-4063-4c48-e054-00144ff8d46c14
1790869Triferic (as elemental iron) 272 MG hemodialysis InjectionSY46ec9233-4063-4c48-e054-00144ff8d46c14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57278-315-0257278031502100 PACKET in 1 CARTON (57278-315-02) > 1 POWDER in 1 PACKET100 packet2016-04-250000-00-00NoNoCurrent