Triferic
- Product NDC
- 57278-314
- 11-digit product format
- 572780314
- Labeler code
- 57278
- Product ID
- 57278-314_af5e96dc-661a-5180-e053-2a95a90a6edc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FERRIC PYROPHOSPHATE
- Dosage form
- SOLUTION
- Route
- HEMODIALYSIS
- Labeler
- Rockwell Medical, Inc
- Application
- NDA206317
- Marketing category
- NDA
- Marketing start
- 2015-02-06
- Marketing end
- 0000-00-00
- Substance
- FERRIC PYROPHOSPHATE CITRATE
- Active strength
- 5 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 | Effective |
|---|---|---|---|
| 04cdd491-d111-4bc2-9549-75c575e1bd4b | Product name | 1 | 20200714 |
| 8390fb8b-6c75-416c-a9a1-70e8ed493b73 | Product name | 1 | 20200611 |
| 96a528e9-23e2-495f-81b9-ae87df2f7552 | Product name | 1 | 20191120 |
| 3df56c93-5837-4523-aac2-4b1ec48b9676 | Product name | 2 | 20160719 |
| a883b7cc-d320-41d7-92ae-c873457ae641 | Product name | 1 | 20151116 |
| bb23e78e-9e64-4037-a1c1-0e1d8762700e | Product name | 1 | 20150325 |
| ef06c001-572c-d95e-42f6-ee83da75673a | Product name | 1 | 20140508 |
| fd21f957-6863-d07b-5a35-250186878716 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 57278-314-02 | 2023-01-30 | C162847 | 48780-1 | f386c649-ea67-0266-e053-dadaa90a7c1a | These 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 | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 57278-314-02 | Triferic | 5 in 1 POUCH | SOLUTION | 5 | 14 | |
| 57278-314-02 | Triferic | 8 in 1 CARTON | SOLUTION | 8 | 14 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57278-314-01 | ML - Milliliter | 57278-314 | 11d9f360-f6cf-4424-a7a5-f0f909110dac | 1 | 2019-06-19 |
| 57278-314-02 | ML - Milliliter | 57278-314 | 27d1b3fb-4bf8-4069-8aa4-93527903fa5d | 1 | 2015-11-12 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1790866 | ferric pyrophosphate (as iron) 272 MG hemodialysis Injection | PSN | 46ec9233-4063-4c48-e054-00144ff8d46c | 14 |
| 1855508 | ferric pyrophosphate citrate (as iron) 27.2 MG in 5 mL hemodialysis Injection | PSN | 46ec9233-4063-4c48-e054-00144ff8d46c | 14 |
| 1855509 | Triferic (iron) 27.2 MG in 5 mL hemodialysis Injection | PSN | 46ec9233-4063-4c48-e054-00144ff8d46c | 14 |
| 1790869 | Triferic (iron) 272 MG hemodialysis Injection | PSN | 46ec9233-4063-4c48-e054-00144ff8d46c | 14 |
| 1855509 | 5 ML ferric pyrophosphate citrate 5.44 MG/ML Injection [Triferic] | SBD | 46ec9233-4063-4c48-e054-00144ff8d46c | 14 |
| 1790869 | ferric pyrophosphate citrate 272 MG Injection [Triferic] | SBD | 46ec9233-4063-4c48-e054-00144ff8d46c | 14 |
| 1855508 | 5 ML ferric pyrophosphate citrate 5.44 MG/ML Injection | SCD | 46ec9233-4063-4c48-e054-00144ff8d46c | 14 |
| 1790866 | ferric pyrophosphate citrate 272 MG Injection | SCD | 46ec9233-4063-4c48-e054-00144ff8d46c | 14 |
| 1790866 | ferric pyrophosphate (as elemental iron) 272 MG hemodialysis Injection | SY | 46ec9233-4063-4c48-e054-00144ff8d46c | 14 |
| 1855508 | ferric pyrophosphate citrate (as iron) 27.2 MG per 5 ML hemodialysis Injection | SY | 46ec9233-4063-4c48-e054-00144ff8d46c | 14 |
| 1855509 | Triferic (as elemental iron) 27.2 MG per 5 ML hemodialysis Injection | SY | 46ec9233-4063-4c48-e054-00144ff8d46c | 14 |
| 1790869 | Triferic (as elemental iron) 272 MG hemodialysis Injection | SY | 46ec9233-4063-4c48-e054-00144ff8d46c | 14 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 57278-314-02 | 57278031402 | 8 POUCH in 1 CARTON (57278-314-02) > 5 AMPULE in 1 POUCH > 5 mL in 1 AMPULE | 8 pouch | 2015-02-06 | 0000-00-00 | No | No | Current |