Triferic

Product NDC
57278-316
11-digit product format
572780316
Labeler code
57278
Product ID
57278-316_9649003d-78eb-9fbe-e053-2995a90a6313
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ferric Pyrophosphate Citrate
Dosage form
SOLUTION
Route
HEMODIALYSIS; INTRAVENOUS
Labeler
Rockwell Medical, Inc
Application
NDA206317
Marketing category
NDA
Marketing start
2015-09-04
Marketing end
0000-00-00
Substance
FERRIC PYROPHOSPHATE CITRATE
Active strength
272 mg/50mL
Pharmacologic classes
Iron [CS],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57278-316-01ML - Milliliter57278-3164bb0bb63-35a0-452d-89ab-41d15f0c06e212017-03-06
57278-316-02ML - Milliliter57278-3162648b920-3349-4bda-81e7-2a708002568c12017-03-06
57278-316-03ML - Milliliter57278-3164564c32c-c27a-4a1d-9041-4562f310868d12017-03-06