FDA.reportPublic FDA data

NDC 59676-310-00 - 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
59676-310
Requested NDC
59676-310-00
Package NDCs from labels
59676-310-00, 59676-310-01, 59676-310-02
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 Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59676-310-00PROCRIT1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION131
59676-310-01PROCRIT6 in 1 CARTONINJECTION, SOLUTION631
59676-310-02PROCRIT25 in 1 CARTONINJECTION, SOLUTION2531

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59676-310PROCRIT (ERYTHROPOIETIN) INJECTION, SOLUTION [JANSSEN PRODUCTS, LP]31Current NDC, Legacy NDC, 3 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
59676-310-00ML - Milliliter59676-3107d7598bc-ad9c-4172-b22a-1257661e496412012-07-24
59676-310-01ML - Milliliter59676-31025e06fd5-fd52-4e8e-932b-80ed8a6d697012012-07-24
59676-310-02ML - Milliliter59676-3104b4f460d-3718-425b-a661-7deb1d17d82612012-07-24

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 1 of 59 · 1,161 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: 451W47IQ8X
SalineNASALRaritan Pharmaceuiticals Inc4b178e4e-a10f-4b75-8140-1f7548e203ad2026-09-09WarningsExact identifier
unii: 451W47IQ8X
Thyroid SupportCALCAREA CARBONICA, CALCAREA IODATA, CAUSTICUM, FERRUM IODATUM, FUCUS VESICULOSUS, KALI IODATUM, NATRUM MURIATICUM, THYROIDINUM (BOVINE)NaturalCare07b4e0ed-2b00-4d0a-ad8f-fc6deff153252026-09-08WarningsExact identifier
unii: 451W47IQ8X
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: 451W47IQ8X
KROGER SalineNASALKROGER COMPANYc84b242b-f46e-4ea8-a3c1-109a476446462026-09-02WarningsExact identifier
unii: 451W47IQ8X
Adrenal SupportADRENALINUM, ARGENTUM NITRICUM, BERBERIS VULGARIS, NATRUM MURIATICUM, OLEUM MORRHUAE, PETROLEUM, VANADIUMNaturalCare31a5d522-15cd-432a-bf87-f721bcbe2e312026-09-02WarningsExact identifier
unii: 451W47IQ8X
Xtreme Saline Rinse MixSODIUM BICARBONATE, SODIUM CHLORIDEXtreme Personal Care Inc776f417e-e443-4918-8c7a-1913b7dddcd42026-09-01WarningsExact identifier
unii: 451W47IQ8X
Nacl 0.9% Normal Saline SolutionSODIUM CHLORIDECHI FUNG TECHNOLOGY COMPANY5a53c4c8-c9de-700c-e063-6394a90a3ab52026-08-31WarningsExact identifier
unii: 451W47IQ8X
BMNP Nat MurNATRUM MURIATICUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro5a57ccfd-ab6f-cb2c-e063-6394a90ae9e62026-08-31WarningsExact identifier
unii: 451W47IQ8X
Allergy CareADRENALINUM, RAGWEED, POLLEN (AMBROSIA ARTEMISIAEFOLIA), APIS MELLIFICA, ECHINACEA (ANGUSTIFOLIA), HISTAMINUM HYDROCHLORICUM, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHURNaturalCaref3ca7f5a-1448-4670-ac02-b47ffb6c55852026-08-27WarningsExact identifier
unii: 451W47IQ8X
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
SalineSALINE NASAL SPRAYDynarex Corporation3247ae7d-554f-baab-e063-6294a90aa3ec2026-08-25WarningsExact identifier
unii: 451W47IQ8X
Electrolyte PlusKALI MURIATICUM, L-ARGININE, L-CARNITINE, L-LEUCINE, L-ORNITHINE, L-VALINE, MAGNESIA MURIATICA, ASCORBICUM ACIDUM, BORAX, CHROMIUM OXYDATUM, FERRUM MURIATICUM, KALI CARBONICUM, MAGNESIUM GLUCONICUM DIHYDRICUM, NATRUM MURIATICUM, ZINCUM GLUCONICUM, CUPRUM METALLICUM, KALI PHOSPHORICUM, NICCOLUM METALLICUM, SELENIUM METALLICUM, VANADIUM METALLICUM, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, MANGANUM CARBONICUMDeseret Biologicals, Inc.e3564733-8b88-4753-9077-9d74004d8ec92026-08-25WarningsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.d5b44f79-5299-4b31-ba45-0e511cdbe17c2026-08-24WarningsExact identifier
unii: 451W47IQ8X
0.9% Benzyl Alcohol Solution (Laboratory Use Only)0.9% BENZYL ALCOHOL SOLUTION (LABORATORY USE ONLY)Guangzhou Huanmei Cosmetics Co., Ltd5976bde6-0999-ffc4-e063-6394a90aadcf2026-08-20WarningsExact identifier
unii: LKG8494WBH
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEYYBA CORP597f3347-647c-3545-e063-6294a90abab22026-08-20WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLC2e5fe9f4-78e5-4af4-8bf9-9680e5dc5e882026-08-20Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sinusforce-HPARSENICUM ALBUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIABioActive Nutritional, Inc.53c96680-210b-4426-8b41-3b9a882848dd2026-08-20WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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