NDC 57278-314
Triferic
Ferric Pyrophosphate
Triferic is a Intravenous Solution in the Human Prescription Drug category. It is labeled and distributed by Rockwell Medical, Inc. The primary component is Ferric Pyrophosphate Citrate.
| Product ID | 57278-314_698459af-84e6-55f5-e053-2a91aa0aac82 |
| NDC | 57278-314 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Triferic |
| Generic Name | Ferric Pyrophosphate |
| Dosage Form | Solution |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2015-02-06 |
| Marketing Category | NDA / NDA |
| Application Number | NDA206317 |
| Labeler Name | Rockwell Medical, Inc |
| Substance Name | FERRIC PYROPHOSPHATE CITRATE |
| Active Ingredient Strength | 5 mg/mL |
| Pharm Classes | Iron [CS],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
Packaging
NDC 57278-314-02
8 POUCH in 1 CARTON (57278-314-02) > 5 AMPULE in 1 POUCH > 5 mL in 1 AMPULE
| Marketing Start Date | 2015-02-06 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 57278-314-01 [57278031401]
Triferic SOLUTION
| Marketing Category | NDA |
| Application Number | NDA206317 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2015-02-06 |
| Marketing End Date | 2019-11-01 |
NDC 57278-314-02 [57278031402]
Triferic SOLUTION
| Marketing Category | NDA |
| Application Number | NDA206317 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2015-02-06 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| FERRIC PYROPHOSPHATE CITRATE | 5.44 mg/mL |
OpenFDA Data
| SPL SET ID: | 46ec9233-4063-4c48-e054-00144ff8d46c |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Iron [CS]
- Parenteral Iron Replacement [EPC]
- Phosphate Binder [EPC]
- Phosphate Chelating Activity [MoA]
NDC Crossover Matching brand name "Triferic" or generic name "Ferric Pyrophosphate"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 57278-314 | Triferic | FERRIC PYROPHOSPHATE |
| 57278-315 | Triferic | FERRIC PYROPHOSPHATE CITRATE |
| 57278-316 | Triferic | Ferric Pyrophosphate Citrate |
| 64811-315 | Triferic | FERRIC PYROPHOSPHATE CITRATE |
Trademark Results [Triferic]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRIFERIC 86036014 4837260 Live/Registered |
ROCKWELL MEDICAL, INC. 2013-08-13 |
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