FDA.reportPublic FDA data

NDC 0517-2325-01 - Venofer

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0517-2325
Requested NDC
0517-2325-01
Package NDCs from labels
0517-2325-01, 0517-2325-10
Manufacturer
American Regent, Inc. | Vifor (International) Inc.
Effective date
2026-03-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Venofer - American Regent, Inc. | Vifor (International) Inc.American Regent, Inc. | Vifor (International) Inc.2026-03-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0517-2325-01Venofer2.5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION2.545
0517-2325-10Venofer10 in 1 BOXINJECTION, SOLUTION1045

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0517-2325VENOFER (IRON SUCROSE) INJECTION, SOLUTION [AMERICAN REGENT, INC.]44Current NDC, Legacy NDC, 2 package rows20240904_626dc9e5-c6b4-4f9c-9bf4-774fd3ae619a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0517-2325-10ML - Milliliter0517-2325b06db8b8-0aed-4ac9-8e4c-4e54c87435ec12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IRON SUCROSEACTIVE INGREDIENTFZ7NYF5N8LVENOFER (IRON SUCROSE) INJECTION, SOLUTION [AMERICAN REGENT, INC.]17
FERRIC CATIONACTIVE MOIETY91O4LML611VENOFER (IRON SUCROSE) INJECTION, SOLUTION [AMERICAN REGENT, INC.]17
WATERINACTIVE INGREDIENT059QF0KO0RVENOFER (IRON SUCROSE) INJECTION, SOLUTION [AMERICAN REGENT, INC.]17

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 2 of 9 · 168 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Iron SucroseIRON SUCROSEInternational Medication Systems, Limited6f19c80e-22e9-4bab-aa53-4d2d958119ed2026-06-05Warnings, Adverse reactionsExact identifier
rxcui: 1741261
rxcui: 1741267
rxcui: 1741270
unii: FZ7NYF5N8L
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
VenoferIRON SUCROSEAmerican Regent, Inc.b998ef36-81fa-40a1-9cd1-6d6156f915642026-03-01Warnings, Adverse reactionsExact identifier
application number: NDA021135
ndc (product): 0517-2340
rxcui: 1741267
rxcui: 1741268
spl id: 215e70bd-ace6-4a58-a31f-ca899ec2eca5
spl set id: b998ef36-81fa-40a1-9cd1-6d6156f91564
unii: FZ7NYF5N8L
VenoferIRON SUCROSEAmerican Regent, Inc.626dc9e5-c6b4-4f9c-9bf4-774fd3ae619a2026-03-01Warnings, Adverse reactionsExact identifier
application number: NDA021135
ndc (package): 0517-2340-01
ndc (package): 0517-2310-01
ndc (package): 0517-2325-10
ndc (package): 0517-2340-10
ndc (package): 0517-2310-05
ndc (package): 0517-2325-01
ndc (package): 0517-2340-25
ndc (product): 0517-2340
ndc (product): 0517-2310
ndc (product): 0517-2325
ndc11 (package): 00517232501
rxcui: 1741263
rxcui: 1741271
rxcui: 1741261
rxcui: 1741267
rxcui: 1741268
rxcui: 1741270
spl id: 500b09f8-36f1-4842-8d07-246fea7bdfd0
spl set id: 626dc9e5-c6b4-4f9c-9bf4-774fd3ae619a
unii: FZ7NYF5N8L
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
Eye CleanEYE WASHHART Health41f53e2e-c2bc-4bf1-a541-3bcb2cf630022025-12-31WarningsExact identifier
unii: 059QF0KO0R
teeth and gumsCALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOSSiddha Flower Essences LLC926c79d5-d270-4c0d-aca9-b58571c24f3a2025-12-31WarningsExact identifier
unii: 059QF0KO0R
lung and sinusCALC PHOS, FERRUM PHOS, GENTIANELLA AMARELLA, FLOS, KALI MUR, KALI PHOS, KALI SULPH, ROCK WATER, ROSE CANINA, FLOSSiddha Flower Essences LLC9f7c949f-21bc-473c-ab8d-24837893fccc2025-12-31WarningsExact identifier
unii: 059QF0KO0R
Quality Choice Eye WashWATERChain Drug Marketing Assoc., Inc.1fb8a109-351b-7039-e063-6394a90a73112025-12-30WarningsExact identifier
unii: 059QF0KO0R
Rite Aid Eye WashPURIFIED WATERRite Aid28a18e04-d735-a511-e063-6394a90af6bb2025-12-30WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.