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

Additional Listing Data#

Finished product
Yes
Brand name base
Velphoro
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FERRIC OXYHYDROXIDE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii87PZU03K0K
Rxcui1484289, 1484296

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
910c1bd7-67d1-44c7-ad4f-9445f827edccProduct name120230808

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49230-645-51Velphoro90 in 1 BOTTLETABLET, CHEWABLE9037
49230-645-51Velphoro1 in 1 CARTONTABLET, CHEWABLE137

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49230-645VELPHORO (SUCROFERRIC OXYHYDROXIDE) TABLET, CHEWABLE [FRESENIUS MEDICAL CARE NORTH AMERICA]31Current NDC, Legacy NDC, 2 package rows20241220_237da26c-f38c-4faa-93ad-735e71c9d0c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1484289sucroferric oxyhydroxide 500 MG Chewable TabletPSN237da26c-f38c-4faa-93ad-735e71c9d0c137
1484296Velphoro 500 MG Chewable TabletPSN237da26c-f38c-4faa-93ad-735e71c9d0c137
1484296sucroferric oxyhydroxide 500 MG Chewable Tablet [Velphoro]SBD237da26c-f38c-4faa-93ad-735e71c9d0c137
1484289sucroferric oxyhydroxide 500 MG Chewable TabletSCD237da26c-f38c-4faa-93ad-735e71c9d0c137
1484296Velphoro 500 MG Chewable TabletSY237da26c-f38c-4faa-93ad-735e71c9d0c137

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49230-645-51492300645511 BOTTLE in 1 CARTON (49230-645-51) / 90 TABLET, CHEWABLE in 1 BOTTLE1 bottle2013-11-270000-00-00NoNoCurrent