FDA.reportPublic FDA data

Triferic AVNU

Product NDC
57278-318
11-digit product format
572780318
Labeler code
57278
Product ID
57278-318_af5e4041-2fca-6927-e053-2995a90aa402
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ferric pyrophosphate citrate
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Rockwell Medical Inc.
Application
NDA212860
Marketing category
NDA
Marketing start
2020-03-30
Marketing end
0000-00-00
Substance
FERRIC PYROPHOSPHATE CITRATE
Active strength
2 mg/mL
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

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
57278-318-022023-01-30C16284748780-1f386c64a-279b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TRIFERIC AVNU safely and effectively. See full prescribing information for TRIFERIC AVNU. TRIFERIC ® AVNU (ferric pyrophosphate citrate injection), for intravenous use Initial U.S. Approval: 2015
57278-318-112023-01-30C16284748780-1f386c64a-279b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TRIFERIC AVNU safely and effectively. See full prescribing information for TRIFERIC AVNU. TRIFERIC ® AVNU (ferric pyrophosphate citrate injection), for intravenous use Initial U.S. Approval: 2015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57278-318-01Triferic AVNU10 in 1 POUCHSOLUTION103
57278-318-01Triferic AVNU4.5 mL in 1 AMPULESOLUTION4.53
57278-318-02Triferic AVNU4 in 1 CARTONSOLUTION43
57278-318-11Triferic AVNU4.5 mL in 1 AMPULESOLUTION4.53
57278-318-11Triferic AVNU1 in 1 POUCHSOLUTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57278-318TRIFERIC AVNU (FERRIC PYROPHOSPHATE CITRATE) SOLUTION [ROCKWELL MEDICAL INC.]3Legacy NDC, 5 package rows20200916_51197a48-6078-42cd-b5ed-5ea22b6757b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2287755ferric pyrophosphate citrate (as iron) 6.75 MG in 4.5 mL hemodialysis InjectionPSN51197a48-6078-42cd-b5ed-5ea22b6757b43
2287757Triferic (iron) 6.75 MG in 4.5 mL hemodialysis InjectionPSN51197a48-6078-42cd-b5ed-5ea22b6757b43
22877574.5 ML ferric pyrophosphate citrate 1.5 MG/ML Injection [Triferic]SBD51197a48-6078-42cd-b5ed-5ea22b6757b43
22877554.5 ML ferric pyrophosphate citrate 1.5 MG/ML InjectionSCD51197a48-6078-42cd-b5ed-5ea22b6757b43
22877574.5 ML Triferic 1.5 MG/ML InjectionSY51197a48-6078-42cd-b5ed-5ea22b6757b43
2287755ferric pyrophosphate citrate (as elemental iron) 6.75 MG per 4.5 ML hemodialysis InjectionSY51197a48-6078-42cd-b5ed-5ea22b6757b43
2287757Triferic (as elemental iron) 6.75 MG per 4.5 ML hemodialysis InjectionSY51197a48-6078-42cd-b5ed-5ea22b6757b43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57278-318-015727803180110 in 1 POUCHHistorical
57278-318-02572780318024 POUCH in 1 CARTON (57278-318-02) > 10 AMPULE in 1 POUCH (57278-318-01) > 4.5 mL in 1 AMPULE4 pouch2020-03-300000-00-00NoNoCurrent
57278-318-11572780318111 AMPULE in 1 POUCH (57278-318-11) > 4.5 mL in 1 AMPULE1 ampule2020-09-150000-00-00YesNoCurrent