Home NDC 49230-645 Velphoro
Product NDC 49230-645
11-digit product format 492300645
Labeler code 49230
Product ID 49230-645_4e6c954e-7710-efc7-e063-6394a90a6dc2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sucroferric oxyhydroxide
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Fresenius Medical Care Renal Therapies Group, LLC
Application NDA205109
Marketing category NDA
Marketing start 2013-11-27
Substance FERRIC OXYHYDROXIDE
Active strength 500 mg/1
Pharmacologic classes Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N205109-001 VELPHORO FERRIC OXYHYDROXIDE EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27
Orange Book patents# Current patent rows page 1 of 1 · 22 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N205109-001 10682376 2028-11-13 Drug product 2020-06-17 N205109-001 10695367 2028-11-13 Drug product 2020-07-01 N205109-001 10925896 2028-11-13 Drug product 2021-03-10 N205109-001 10925897 2028-11-13 Drug product 2021-03-10 N205109-001 10933090 2028-11-13 Drug product 2021-03-10 N205109-001 11013761 2028-11-13 Drug product 2021-06-02 N205109-001 11013762 2028-11-13 Drug product 2021-06-02 N205109-001 10682376*PED 2029-05-13 Pediatric extension N205109-001 10695367*PED 2029-05-13 Pediatric extension N205109-001 10925896*PED 2029-05-13 Pediatric extension N205109-001 10925897*PED 2029-05-13 Pediatric extension N205109-001 10933090*PED 2029-05-13 Pediatric extension N205109-001 11013761*PED 2029-05-13 Pediatric extension N205109-001 11013762*PED 2029-05-13 Pediatric extension N205109-001 9561251 2030-01-23 U-1468 Drug product 2017-03-02 N205109-001 9561251*PED 2030-07-23 Pediatric extension N205109-001 10624855 2034-11-26 Drug product 2020-04-27 N205109-001 11234938 2034-11-26 Drug product 2022-02-17 N205109-001 11446252 2034-11-26 Drug product 2022-09-20 N205109-001 10624855*PED 2035-05-26 Pediatric extension N205109-001 11234938*PED 2035-05-26 Pediatric extension N205109-001 11446252*PED 2035-05-26 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N205109-001 NPP 2027-07-01 N205109-001 PED 2028-01-01
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.
Product history page 1 of 2 · 41 observed 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 2026-02-19 14:30 UTC 2026-02 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N205109-001 VELPHORO 500MG TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N205109-001 VELPHORO 500MG TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N205109-001 VELPHORO 500MG TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N205109-001 VELPHORO 500MG TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N205109-001 VELPHORO 500MG TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N205109-001 VELPHORO 500MG TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N205109-001 VELPHORO 500MG TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N205109-001 VELPHORO 500MG TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 19 · 728 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N205109-001 10682376 2028-11-13 Drug product 2020-06-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205109-001 10695367 2028-11-13 Drug product 2020-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205109-001 10925896 2028-11-13 Drug product 2021-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205109-001 10925897 2028-11-13 Drug product 2021-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205109-001 10933090 2028-11-13 Drug product 2021-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205109-001 11013761 2028-11-13 Drug product 2021-06-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205109-001 11013762 2028-11-13 Drug product 2021-06-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205109-001 10682376*PED 2029-05-13 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205109-001 10695367*PED 2029-05-13 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205109-001 10925896*PED 2029-05-13 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205109-001 10925897*PED 2029-05-13 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205109-001 10933090*PED 2029-05-13 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205109-001 11013761*PED 2029-05-13 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205109-001 11013762*PED 2029-05-13 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205109-001 9561251 2030-01-23 U-1468 Drug product 2017-03-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205109-001 9561251*PED 2030-07-23 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205109-001 10624855 2034-11-26 Drug product 2020-04-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205109-001 11234938 2034-11-26 Drug product 2022-02-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205109-001 11446252 2034-11-26 Drug product 2022-09-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205109-001 10624855*PED 2035-05-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205109-001 11234938*PED 2035-05-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205109-001 11446252*PED 2035-05-26 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205109-001 10682376 2028-11-13 Drug product 2020-06-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205109-001 10695367 2028-11-13 Drug product 2020-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205109-001 10925896 2028-11-13 Drug product 2021-03-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205109-001 10925897 2028-11-13 Drug product 2021-03-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205109-001 10933090 2028-11-13 Drug product 2021-03-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205109-001 11013761 2028-11-13 Drug product 2021-06-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205109-001 11013762 2028-11-13 Drug product 2021-06-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205109-001 10682376*PED 2029-05-13 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205109-001 10695367*PED 2029-05-13 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205109-001 10925896*PED 2029-05-13 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205109-001 10925897*PED 2029-05-13 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205109-001 10933090*PED 2029-05-13 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205109-001 11013761*PED 2029-05-13 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205109-001 11013762*PED 2029-05-13 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205109-001 9561251 2030-01-23 U-1468 Drug product 2017-03-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205109-001 9561251*PED 2030-07-23 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205109-001 10624855 2034-11-26 Drug product 2020-04-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205109-001 11234938 2034-11-26 Drug product 2022-02-17 31067a03dcf5…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Velphoro
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FERRIC OXYHYDROXIDE 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 87PZU03K0K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1484289 Internal RxNorm lookup 1484296 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49230-645-51 Velphoro 90 in 1 BOTTLE TABLET, CHEWABLE 90 37 49230-645-51 Velphoro 1 in 1 CARTON TABLET, CHEWABLE 1 37
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49230-645 VELPHORO (SUCROFERRIC OXYHYDROXIDE) TABLET, CHEWABLE [FRESENIUS MEDICAL CARE NORTH AMERICA] 31 Current NDC, Legacy NDC, 2 package rows 20241220_237da26c-f38c-4faa-93ad-735e71c9d0c1.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Velphoro SUCROFERRIC OXYHYDROXIDE Fresenius Medical Care Renal Therapies Group, LLC 237da26c-f38c-4faa-93ad-735e71c9d0c1 2026-04-01 Warnings, Adverse reactions Exact identifier application applno (NDA): 205109 application number: NDA205109 ndc (product): 49230-645
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 49230-645-51 49230064551 1 BOTTLE in 1 CARTON (49230-645-51) / 90 TABLET, CHEWABLE in 1 BOTTLE 1 bottle 2013-11-27 0000-00-00 No No Current