FDA.reportPublic FDA data

NDC 65219-021-00 - Oxytocin

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
65219-021
Requested NDC
65219-021-00
Package NDCs from labels
65219-021-00, 65219-021-01
Manufacturer
Fresenius Kabi USA, LLC
Effective date
2025-03-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Oxytocin - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2025-03-24HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65219-021-00Oxytocin1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION12
65219-021-01Oxytocin25 in 1 TRAYINJECTION, SOLUTION252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-021OXYTOCIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2Current NDC, 2 package rows20250409_4c4c4b69-8bf7-472c-aafe-29805ba5c965.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-021-00ML - Milliliter65219-021e2418f81-f3e2-41af-9491-6f91d8fc5e5612025-10-14
65219-021-01ML - Milliliter65219-02171409996-013d-404a-8a97-f492abf5ebaa12025-10-14

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 8 of 13 · 253 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Endopan HPACETICUM ACIDUM, COLCHICUM AUTUMNALE, LACTICUM ACIDUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SYZYGIUM JAMBOLANUM, URANIUM NITRICUMEnergique, Inc.0d475595-7afe-423f-9da8-720f1513f9562024-10-24WarningsExact identifier
unii: Q40Q9N063P
Dental PainACETICUM ACIDUM, CALENDULA OFFICINALIS, ZINGIBER OFFICINALE, BRYONIA (ALBA), COFFEA TOSTA, LEDUM PALUSTRE, PHOSPHORUS, PLANTAGO MAJOR, SPIGELIA ANTHELMIA, ARNICA MONTANA, CHAMOMILLA, HEPAR SULPHURIS CALCAREUM, HYPERICUM PERFORATUM, ACONITUM NAPELLUS, ANTIMONIUM CRUDUM, MEZEREUM, SEPIA, STAPHYSAGRIA, MAGNESIA PHOSPHORICADeseret Biologicals, Inc.3a117358-3c51-4870-9932-701ffe90e3f82024-10-23WarningsExact identifier
unii: Q40Q9N063P
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.9aa060f1-f8f6-46e6-a7d0-bd46a73f26762024-10-17WarningsExact identifier
unii: Q40Q9N063P
OxytocinOXYTOCINFresenius Kabi USA, LLC6d7d1280-f286-4f39-89f3-2b96571810e62024-10-15Warnings, Adverse reactionsExact identifier
application number: NDA018248
rxcui: 1791721
unii: 1JQS135EYN
EyS Eye WashWATEREyes-Plus LLC1443f6bf-3a77-4a19-8585-0ec58efe042f2024-10-15WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATER SOLUTIONKroger Company354402ad-581d-47e7-9fd3-933bef281ff42024-10-11WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATERHubei Changjian Medical Products Co., Ltd.d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea2024-10-11WarningsExact identifier
unii: 059QF0KO0R
EmpathyAETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATADeseret Biologicals, Inc.a89067c1-ef12-49da-8fa6-e65ff664f4972024-08-13WarningsExact identifier
unii: 059QF0KO0R
PitocinOXYTOCINPar Health USA, LLCdddcdcc3-cd4d-4573-98ac-9468bea23a8b2024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1791721
unii: 1JQS135EYN
Acetic AcidACETIC ACIDNuCare Pharmaceuticals,Inc.7470a1ed-bc00-cb52-e053-2a91aa0a5c7d2024-07-15Warnings, Adverse reactionsExact identifier
unii: Q40Q9N063P
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
unii: 059QF0KO0R
Eyes Alive Eye WashWATERRIVIERA PHARMA INC081079f4-1c06-4054-b771-00fedaa666f62024-06-05WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBecton Dickinson and Company6e43c5a3-dad2-49ed-b500-964cb4563cc92024-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Weight Loss Support Plus Female BalanceFOENICULUM VULGARE, AMMONIUM BROMATUM, FUCUS VESICULOSUS, LECITHIN (DERIVED FROM EGG), CAPSICUM ANNUUM, CAULOPHYLLUM THALICTRINES, CIMICIFUGA RACEMOSA, GALIUM APARINE, HYPOTHALAMUS SUIS, KALI BICHROMICUM, LAC DEFLORATUM, PHYTOLACCA DECANDRA, RUBUS IDAEUS, THYROIDINUM (BOVINE), PITUITARUM POSTERIUM (BOVINE), ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, CALCAREA CARBONICA, ADRENALINUM, PHOSPHORUS, HEPAR SULPHURIS CALCAREUM, PROGESTERONE, OXYTOCINCarolinas Weight Loss Institute66249339-1e80-449f-9c2a-a030cdc71a0c2024-05-23WarningsExact identifier
unii: 1JQS135EYN
IntimateNATRUM CARBONICUM, SACCHARUM OFFICINALE, LITHIUM CARBONICUM, PLACENTA TOTALIS SUIS, LAC CANINUM, ANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, GERMANIUM METALLICUM, HELLEBORUS NIGER, MAGNESIA OXYDATA, RHUS GLABRA, STRAMONIUM, THUJA OCCIDENTALIS, DNA (HUMAN), OXYTOCIN, HYDROGEN, NEON, LAC MATERNA HUMANUMDeseret Biologicals, Inc.ca0447c1-606e-443a-b789-7d65143fec282024-05-13WarningsExact identifier
unii: 1JQS135EYN
Weight Loss Support Plus Female BalanceFOENICULUM VULGARE, AMMONIUM BROMATUM, FUCUS VESICULOSUS, LECITHIN (DERIVED FROM EGG), CAPSICUM ANNUUM, CAULOPHYLLUM THALICTROIDES, CIMICIFUGA RACEMOSA, GALIUM APARINE, HYPOTHALAMUS SUIS, KALI BICHROMICUM, LAC DEFLORATUM (NSPC), PHYTOLACCA DECANDRA, RUBUS IDAEUS, THYROIDINUM (BOVINE), PITUITARUM POSTERIUM ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, CALCAREA CARBONICA, ADRENALINUM, PHOSPHORUS, HEPAR SULPHURIS CALCAREUM, OXYTOCIN, PROGESTERONECarolinas Weight Loss Institute52ce70ad-7ed6-4559-8c4c-590bf7b10e652024-05-13WarningsExact identifier
unii: 1JQS135EYN
GI DistressACETICUM ACIDUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BISMUTHUM SUBNITRICUM, CINCHONA OFFICINALIS, COLCHICUM AUTUMNALE, COLIBACILLINUM CUM NATRUM MURIATICUM, COLOCYNTHIS, CROTON TIGLIUM, ECHINACEA (ANGUSTIFOLIA), FERRUM METALLICUM, GAMBOGIA, IRIS VERSICOLOR, LAC DEFLORATUM, MERCURIUS VIVUS, NATRUM PHOSPHORICUM, NUX VOMICA, PROTEUS (MIRABILIS), RICINUS COMMUNIS, VERATRUM ALBUMDeseret Biologicals, Inc.40df69fa-92ae-4f26-8664-36955cf395c52024-05-13WarningsExact identifier
unii: Q40Q9N063P
GI DistressECHINACEA (ANGUSTIFOLIA), NATRUM PHOSPHORICUM, COLCHICUM AUTUMNALE, ARSENICUM ALBUM, COLOCYNTHIS, CROTON TIGLIUM, GAMBOGIA, ACETICUM ACIDUM, ANTIMONIUM CRUDUM, BISMUTHUM SUBNITRICUM, CINCHONA OFFICINALIS, FERRUM METALLICUM, IRIS VERSICOLOR, LAC DEFLORATUM, MERCURIUS VIVUS, NUX VOMICA, RICINUS COMMUNIS, VERATRUM ALBUM, COLIBACILLINUM CUM NATRUM MURIATICUM, PROTEUS (MIRABILIS)Deseret Biologicals, Inc.056ac695-82d3-4164-9123-79520b5deecc2024-05-08WarningsExact identifier
unii: Q40Q9N063P
Neurotransmitter ProAETHUSA CYNAPIUM, GINKGO BILOBA, KALI PHOSPHORICUM, CEREBRUM SUIS, HYPOTHALAMUS SUIS, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALUMINA, ANACARDIUM ORIENTALE, ARSENICUM ALBUM, CORTISONE ACETICUM, LEVOTHYROXINUM, LYCOPODIUM CLAVATUM, NADIDUM, PHOSPHORUS, UBIDECARENONUM, ZINCUM METALLICUM, ACETYLCHOLINE CHLORIDE, DOPAMINE HYDROCHLORIDE, GABA (GAMMA-AMINOBUTYRIC ACID), HISTAMINUM HYDROCHLORICUM, MELATONIN, NOREPINEPHRINE (BITARTRATE), OXYTOCIN, SEROTONIN (HYDROCHLORIDE)Energique, Inc.a80e5e2d-4c53-4b18-b89b-a7790073b7ed2024-05-06WarningsExact identifier
unii: 1JQS135EYN

Reported adverse events (FAERS/openFDA)#

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