Home NDC 57278-316 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N206317-001 TRIFERIC FERRIC PYROPHOSPHATE CITRATE 27.2MG IRON/5ML (5.44MG IRON/ML) SOLUTION / INTRAVENOUS RLD 2015-01-23 N206317-002 TRIFERIC FERRIC PYROPHOSPHATE CITRATE 272MG IRON/50ML (5.44MG IRON/ML) SOLUTION / INTRAVENOUS RLD 2015-09-04
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N206317-001 7816404 2029-04-17 U-1656 Drug product 2015-02-20
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N206317-001 TRIFERIC 27.2MG IRON/5ML (5.44MG IRON/ML) SOLUTION / INTRAVENOUS RLD 2015-01-23 a50c72e98297…2026-08-01 22:54:32 2026-06 N206317-002 TRIFERIC 272MG IRON/50ML (5.44MG IRON/ML) SOLUTION / INTRAVENOUS RLD 2015-09-04 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N206317-001 7816404 2029-04-17 U-1656 Drug product 2015-02-20 a50c72e98297…