Home NDC 49230-646 Velphoro
Product NDC 49230-646
11-digit product format 492300646
Labeler code 49230
Product ID 49230-646_5ec19308-78b6-f929-e063-6294a90a1fc3
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 250 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 45 .
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 N205109-001 VELPHORO FERRIC OXYHYDROXIDE EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 N205109-002 VELPHORO FERRIC OXYHYDROXIDE EQ 250MG IRON TABLET, CHEWABLE / ORAL RLD 2026-10-13
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 · 4 matching rows.
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 · 46 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 2026-11-14 07:37:17 2026-10 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N205109-002 VELPHORO EQ 250MG IRON TABLET, CHEWABLE / ORAL RLD 2026-10-13 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 c2088c7a36db…2026-09-14 22:38:34 2026-08 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 caaa826d4ba7…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…
Observed Orange Book patent history# Patent history page 1 of 21 · 816 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-11-14 07:37:17 2026-10 N205109-001 10682376 2028-11-13 Drug product 2020-06-17 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N205109-001 10695367 2028-11-13 Drug product 2020-07-01 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N205109-001 10925896 2028-11-13 Drug product 2021-03-10 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N205109-001 10925897 2028-11-13 Drug product 2021-03-10 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N205109-001 10933090 2028-11-13 Drug product 2021-03-10 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N205109-001 11013761 2028-11-13 Drug product 2021-06-02 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N205109-001 11013762 2028-11-13 Drug product 2021-06-02 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N205109-001 10682376*PED 2029-05-13 Pediatric extension d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N205109-001 10695367*PED 2029-05-13 Pediatric extension d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N205109-001 10925896*PED 2029-05-13 Pediatric extension d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N205109-001 10925897*PED 2029-05-13 Pediatric extension d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N205109-001 10933090*PED 2029-05-13 Pediatric extension d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N205109-001 11013761*PED 2029-05-13 Pediatric extension d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N205109-001 11013762*PED 2029-05-13 Pediatric extension d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N205109-001 9561251 2030-01-23 U-1468 Drug product 2017-03-02 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N205109-001 9561251*PED 2030-07-23 Pediatric extension d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N205109-001 10624855 2034-11-26 Drug product 2020-04-27 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N205109-001 11234938 2034-11-26 Drug product 2022-02-17 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N205109-001 11446252 2034-11-26 Drug product 2022-09-20 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N205109-001 10624855*PED 2035-05-26 Pediatric extension d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N205109-001 11234938*PED 2035-05-26 Pediatric extension d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N205109-001 11446252*PED 2035-05-26 Pediatric extension d4dbc9d85df4…2026-10-15 13:18:30 2026-09 N205109-001 10682376 2028-11-13 Drug product 2020-06-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N205109-001 10695367 2028-11-13 Drug product 2020-07-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N205109-001 10925896 2028-11-13 Drug product 2021-03-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N205109-001 10925897 2028-11-13 Drug product 2021-03-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N205109-001 10933090 2028-11-13 Drug product 2021-03-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N205109-001 11013761 2028-11-13 Drug product 2021-06-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 N205109-001 11013762 2028-11-13 Drug product 2021-06-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 N205109-001 10682376*PED 2029-05-13 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N205109-001 10695367*PED 2029-05-13 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N205109-001 10925896*PED 2029-05-13 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N205109-001 10925897*PED 2029-05-13 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N205109-001 10933090*PED 2029-05-13 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N205109-001 11013761*PED 2029-05-13 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N205109-001 11013762*PED 2029-05-13 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N205109-001 9561251 2030-01-23 U-1468 Drug product 2017-03-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 N205109-001 9561251*PED 2030-07-23 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N205109-001 10624855 2034-11-26 Drug product 2020-04-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 N205109-001 11234938 2034-11-26 Drug product 2022-02-17 c2088c7a36db…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Velphoro
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FERRIC OXYHYDROXIDE 250 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1484289 Internal RxNorm lookup 1484296 Internal RxNorm lookup 2755814 Internal RxNorm lookup 2755816 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Socrata Ingredients# DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 49230-646-61 49230064661 1 BOTTLE in 1 CARTON (49230-646-61) / 90 TABLET, CHEWABLE in 1 BOTTLE 1 bottle 2013-11-27 No No Current