FDA.reportPublic FDA data

NDC 59676-320-00 - PROCRIT

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
59676-320
Requested NDC
59676-320-00
Package NDCs from labels
59676-320-00, 59676-320-04
Manufacturer
Janssen Products, LP | Amgen, Inc. | Patheon Manufacturing Services LLC | Amgen Manufacturing Ltd
Effective date
2025-04-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PROCRIT - Janssen Products, LP | Amgen, Inc. | Patheon Manufacturing Services LLC | Amgen Manufacturing LtdJanssen Products, LP | Amgen, Inc. | Patheon Manufacturing Services LLC | Amgen Manufacturing Ltd2025-04-09HUMAN PRESCRIPTION DRUG LABEL
PROCRIT - Physicians Total Care, Inc.Physicians Total Care, Inc.2013-01-17HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-06-04Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59676-320-00PROCRIT1 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION131
59676-320-04PROCRIT4 in 1 CARTONINJECTION, SOLUTION431

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59676-320PROCRIT (ERYTHROPOIETIN) INJECTION, SOLUTION [JANSSEN PRODUCTS, LP]31Current NDC, Legacy NDC, 2 package rows20250410_0c721ba4-ae19-417f-aae1-221ed1a0866a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59676-320-00ML - Milliliter59676-3201c772b64-8ff3-47f5-8a0a-4694fe62c14112013-06-04
59676-320-04ML - Milliliter59676-320dfea93c9-82ed-4d5a-a066-edce7b4b953912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ErythropoietinACTIVE INGREDIENT64FS3BFH5WPROCRIT (ERYTHROPOIETIN) INJECTION, SOLUTION [JANSSEN PRODUCTS, LP]21
ErythropoietinACTIVE MOIETY64FS3BFH5WPROCRIT (ERYTHROPOIETIN) INJECTION, SOLUTION [JANSSEN PRODUCTS, LP]21
albumin (human)INACTIVE INGREDIENTZIF514RVZRPROCRIT (ERYTHROPOIETIN) INJECTION, SOLUTION [JANSSEN PRODUCTS, LP]21
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHPROCRIT (ERYTHROPOIETIN) INJECTION, SOLUTION [JANSSEN PRODUCTS, LP]21
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPPROCRIT (ERYTHROPOIETIN) INJECTION, SOLUTION [JANSSEN PRODUCTS, LP]21
sodium chlorideINACTIVE INGREDIENT451W47IQ8XPROCRIT (ERYTHROPOIETIN) INJECTION, SOLUTION [JANSSEN PRODUCTS, LP]21
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRPROCRIT (ERYTHROPOIETIN) INJECTION, SOLUTION [JANSSEN PRODUCTS, LP]21
sodium phosphate, dibasic, anhydrousINACTIVE INGREDIENT22ADO53M6FPROCRIT (ERYTHROPOIETIN) INJECTION, SOLUTION [JANSSEN PRODUCTS, LP]21
sodium phosphate, monobasic, monohydrateINACTIVE INGREDIENT593YOG76RNPROCRIT (ERYTHROPOIETIN) INJECTION, SOLUTION [JANSSEN PRODUCTS, LP]21
waterINACTIVE INGREDIENT059QF0KO0RPROCRIT (ERYTHROPOIETIN) INJECTION, SOLUTION [JANSSEN PRODUCTS, LP]21
ErythropoietinACTIVE INGREDIENT64FS3BFH5WPROCRIT (ERYTHROPOIETIN) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
ErythropoietinACTIVE MOIETY64FS3BFH5WPROCRIT (ERYTHROPOIETIN) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
albumin (human)INACTIVE INGREDIENTZIF514RVZRPROCRIT (ERYTHROPOIETIN) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHPROCRIT (ERYTHROPOIETIN) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPPROCRIT (ERYTHROPOIETIN) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
sodium chlorideINACTIVE INGREDIENT451W47IQ8XPROCRIT (ERYTHROPOIETIN) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRPROCRIT (ERYTHROPOIETIN) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
sodium phosphate, dibasic, anhydrousINACTIVE INGREDIENT22ADO53M6FPROCRIT (ERYTHROPOIETIN) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
sodium phosphate, monobasic, monohydrateINACTIVE INGREDIENT593YOG76RNPROCRIT (ERYTHROPOIETIN) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
waterINACTIVE INGREDIENT059QF0KO0RPROCRIT (ERYTHROPOIETIN) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]2

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 4 of 58 · 1,149 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
The Cell Salt Co. Daily Blend 12 in 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAThe Cell Salt Company LLC55826f59-acf4-7370-e063-6394a90afed72026-07-01WarningsExact identifier
unii: 451W47IQ8X
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC55820ff9-7b4b-2bce-e063-6394a90a8b432026-06-30WarningsExact identifier
unii: 451W47IQ8X
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC55806cb8-cf92-c4e5-e063-6394a90aaa2d2026-06-30WarningsExact identifier
unii: 451W47IQ8X
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC5581d8e5-4105-e9da-e063-6394a90a316e2026-06-30WarningsExact identifier
unii: 451W47IQ8X
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BOVISTA, CARBO VEGETABILIS, CARBONEUM SULPHURATUM, COFFEA CRUDA, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SULPHUR, ACETYLSALICYLICUM ACIDUM, FORMALINUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, TEREBINTHINA, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM,Energique, Inc.2e361b50-9268-4053-b13c-93af645498482026-06-25WarningsExact identifier
unii: LKG8494WBH
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fd8a72-0527-df0c-e063-6294a90abe752026-06-24Exact identifier
unii: 2968PHW8QP
unii: 1Q73Q2JULR
unii: 593YOG76RN
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fddca1-b40c-7af0-e063-6294a90a410e2026-06-24Exact identifier
unii: 2968PHW8QP
unii: 1Q73Q2JULR
unii: 593YOG76RN
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fdf83e-f641-1f69-e063-6394a90ab7502026-06-24Exact identifier
unii: 2968PHW8QP
unii: 1Q73Q2JULR
unii: 593YOG76RN
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
MCAS SupportAPIS MELLIFICA, ANTIMONIUM CRUDUM, ASCORBICUM ACIDUM, BOVISTA, CARBOLICUM ACIDUM, CHAMOMILLA, CORTISONE ACETICUM, GINKGO BILOBA, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, NATRUM MURIATICUM, QUERCETIN, RHUS TOX, SCUTELLARIA LATERIFLORA, STOMACH (SUIS), URTICA URENSDeseret Biologicals, Inc.af3d5f8f-6f24-4045-8730-c776ff54bcc42026-06-24WarningsExact identifier
unii: 451W47IQ8X
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
EPOGENEPOETIN ALFAAmgen, Inc1f2d0b28-9cc5-4523-80b8-637fdaf3f7a52026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA103234
rxcui: 1721684
rxcui: 239998
rxcui: 240377
rxcui: 241999
rxcui: 240000
rxcui: 239999
unii: 64FS3BFH5W
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
0.9% Sodium Chloride Saline SolutionSODIUM CHLORIDEYunqi Cosmetics (Shenzhen) Co., Ltd546af257-dbd1-11fc-e063-6394a90a8e0a2026-06-16WarningsExact identifier
unii: 451W47IQ8X
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd.395aec48-198a-4aed-8e38-7accfb3232f92026-06-15Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
BM BM68 DROPSARGENTUM NIT, BARYTA CARB., DULCAMARA, GELSEMIUM, KALI BROM, NAT MUR, CAUSTICUMBM Private Limited53f9c99a-0f20-0358-e063-6394a90af4e02026-06-15WarningsExact identifier
unii: 451W47IQ8X
BM BM68ARGENTUM NIT, BARYTA CARB, DULCAMARA, GELSEMIUM, KALI BROM, NAT MUR, CAUSTICUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro5448c76a-2ecb-9402-e063-6294a90a6ad72026-06-15WarningsExact identifier
unii: 451W47IQ8X
BM BIO28 ALCOHOLCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro544b66c4-49df-556f-e063-6394a90af3ed2026-06-15WarningsExact identifier
unii: 451W47IQ8X
Male SupportAGNUS CASTUS, AURUM METALLICUM, BENZOICUM ACIDUM, BRYONIA (ALBA), BUFO RANA, CALADIUM SEGUINUM, CHIMAPHILA UMBELLATA, CLEMATIS ERECTA, CONIUM MACULATUM, CORTISONE ACETICUM, HYPOTHALAMUS SUIS, KALI ARSENICOSUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PROSTATE (SUIS), RHODODENDRON CHRYSANTHUM, SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, TESTOSTERONE, THUJA OCCIDENTALISDeseret Biologicals, Inc.29cefc89-3bb6-484e-84ab-116b5827a4c32026-06-15WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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